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Unpacking HACCP 7 Principles: How to set up a HACCP Plan?

HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the food industry. It is a concept designed to identify and prevent or eliminate any potential hazards that may put consumers at risk of food-borne illnesses. This guide will take an in-depth look into what HACCP is and how it can be used to ensure food safety and quality.

When it comes to food safety, compliance is a top priority for any business. And that means consulting with the right experts to ensure your operations are up to code. The company has years of experience helping businesses navigate the complex world of food safety regulations.

7 principles Haccp, How to Set up a HACCP or PCP

This blog post will look at 7 HACCP principles every food safety consultant should know. These principles will help you understand your clients and work more effectively with them to ensure compliance.

How to set up a HACCP Plan?

Setting up a HACCP plan is an important first step when becoming certified or licensing your business. This plan will help identify potential hazards and create a process to reduce the risk of foodborne illness. Many software applications can help you create your HACCP plan but choosing one that is comprehensive and easy to use is important.

The Food Safety Modernization Act (FSMA) requires all food businesses with 20 or more employees to have a written HACCP plan by January 1, 2017. If you are not already licensed or certified, getting started on your HACCP plan as soon as possible is important. There are a number of resources available online and through your state Extension office that can help guide you through the process.

Once you have created your HACCP plan, you must implement it correctly. A good way is to conduct regular “sanitation audits” of your operations.

What is HACCP?

HACCP is a systematic approach to identifying, assessing, and controlling hazards in food operations. It is a globally accepted method for preventing safety risks associated with the production of foods. HACCP works by requiring food producers to identify potential risks from a holistic point-of-view and then develop a plan to address those risks. The goal is to make sure that all control points in the food production process are identified and monitored so that there is minimal risk from hazards such as contamination or spoilage.

Regulatory Consulting HACCP 7 Principles Unlocked

1.    Identify and analyze hazards (Principle # 1)

Hazard identification and analysis are essential to developing a safe food safety plan. The first step in hazard identification is to identify potential food safety hazards. To do this, you need to understand the basic principles of hazard analysis.

The first principle of hazard analysis is that all hazards are related. It means that if you identify one risk factor, you’re likely to also identify other associated risks. For example, if you’re looking at the potential for bacteria contamination, you’ll need to consider heat exposure, cross-contamination, and moisture levels.

The second principle of hazard analysis is that all hazards can cause food safety problems. It means that no matter how small the risk may seem, it can still lead to an unsafe product if it’s not properly addressed. For example, even a very small number of Listeria monocytogenes cells can cause serious illness in people who eat contaminated food.

The final principle of hazard analysis is that food safety risks can vary depending on the situation. It means that different risks might be more or less likely to occur in different scenarios, such as during production (when there’s a high level of contamination) or during distribution (when products reach consumers).

2.  Determine the Critical Control Points (CCPs) (Principle # 2)

When determining the CCPs for a food production facility, there are many things to consider. The key is to identify points where contamination could easily occur and take action to prevent it.

The following tips will help you determine the CCPs:

  • Look at the layout of the facility and make a list of potential contamination points. These include where raw materials or finished products are handled, workers enter and exit the facility, or equipment is maintained.
  • Evaluate how easily contaminants could enter or leave the facility. For example, if there are many entrances and exits, contaminants may be less likely to stay inside the facility. If there are few points of entry, then contaminants may be more likely to spread throughout the facility.
  • Consider how cleanliness affects CCPs. For example, if bacteria can live on surfaces for a short time, then they may be able to contaminate food products during manufacturing or storage. Similarly, dirty equipment can create conditions that allow spoilage and infection.

3.  Establish Critical Limits for each CCP (Principle # 3)

The third CCP principle is establishing Critical Limits. Critical limits are the maximum amount of contaminants or pollutants that CCPs can release into the environment. By reaching and keeping critical limits, the CCPs work as they should and do not pose an unacceptable risk to human health or the environment.

A company must first identify the contaminants or pollutants that comprise the CCPs’ emission profile to establish critical limits. Once the profile is known, a company can use mathematical models to determine the allowable levels of each contaminant in air, water, or soil. The allowable levels should be set at a level that protects human health and the environment while allowing for normal operations of the CCPs.

Setting critical limits is a complex process that requires careful consideration of all factors involved in emissions from a CCP. It is important to remember that critical limits may change over time as new information becomes available about how contaminants interact with each other and with humans and the environment. Therefore, it is important for companies to regularly review their critical limit settings and make any necessary adjustments.

4.  Establish a Monitoring Procedure (Principle # 4)

There are a few things that you should consider when establishing your monitoring procedure in order to ensure compliance with HACCP principles.

You first need to decide what type of monitoring you will do. You can choose to monitor either the process or the product. The choice depends on which area of concern most concerns you.

If you are concerned about the quality of the product, then you should focus on monitoring the process. It means focusing on things like cleanliness, sanitation, and hygiene. You should also track how often products are produced and tracked throughout their life cycle.

Need FSVP Assistance or help Creating a HACCP Plan?

5.  Establish Corrective Actions (Principle # 5)

Develop corrective actions for identified deficiencies in safety performance.

A regulatory consulting firm must be able to identify and correct deficiencies in safety performance, regardless of the cause. Identifying and correcting deficiencies takes a comprehensive approach that includes inspection, review of records, interviews, and data analyses. Once the deficiencies are identified, consultants should develop corrective actions to ensure that operations continue to meet applicable safety standards.

6.  Verify the HACCP Plan (Principle # 6)

HACCP verification is important in ensuring that your food safety plan is effective. The verification process helps to ensure that all key elements of your HACCP plan are in place and operational. It also allows you to identify any plan deviations and determine if corrective action is necessary.

One of the most important aspects of verification is verifying the holding temperature of food. This parameter should be held at a temperature that will prevent spoilage and should not exceed 41 degrees Celsius (105 degrees Fahrenheit). If the food is not held at this temperature, it may be subject to microbial growth, resulting in foodborne illness.

7.  Keep Records (Principle # 7)

Keeping records is the key to compliance and ensuring regulatory compliance. By keeping records, you can ensure that all relevant information is captured and preserved to allow easy retrieval during an audit or inquiry.

There are a few different ways to keep your records: written, electronic, or both. The most important factor is having a system that allows you to easily capture and track information. You should also make sure that all records are accurate and up to date.

Record keeping is an important aspect of the HACCP plan due to the following:

  1. Offers traceability and transparency
  2. Ensures due diligence
  3. Provides a record of complaints with critical limits set
  4. Identifies potential problems

You should also maintain detailed logs of all interactions with regulators, including phone calls, e-mails, meeting minutes, and correspondence. This information will help you reconstruct what occurred during any interaction and remember any pertinent details.

How to Implement the HACCP System in Your Food Facility:

Once you have all the basics in place, there are certain steps to take when beginning to establish and implement your HACCP system. First, you must create a HACCP team, which should include people knowledgeable about the process and familiar with the equipment and production environment. After that, your team will identify each stage within the process, determine what kind of hazard is present at that stage, and figure out how to prevent or reduce that hazard using predetermined controls. Finally, it’s time to create a detailed plan document outlining exactly what needs to be done – from pre-requisite programs, monitoring procedures, and corrective actions – while documenting all evidence along the way.

How can I maintain and audit my HACCP system?

After your HACCP system is established and documented, you need to make sure that it’s implemented and maintained properly. You should periodically conduct reviews of all pre-requisite programs, monitoring procedures, and corrective actions; take feedback from team members regarding the effectiveness of the system; and update documents as necessary. Additionally, carry out independent audits in order to evaluate performance and identify any additional improvements that can be made. Doing so will give you greater confidence that your team can deliver safe, quality food products every time.

What are the responsibilities of team members when implementing a HACCP plan?

Every member of the HACCP team has a role to play in the successful application and maintenance of the system. The HACCP Coordinator is typically responsible for ensuring that the HACCP plan is in compliance with regulatory requirements and successfully implemented by all team members. This individual also serves as a point of contact for any questions about HACCP and monitors the overall performance of the process. A Team Leader should implement the program, actively listen to any concerns from their colleagues, ensure compliance with regulations, investigate any possible food safety issues, and report back to the Coordinator on status updates. All team members must be trained thoroughly in how to perform their respective roles and must comply with every aspect of the established HACCP system.

Conclusion

As a business owner, you are likely familiar with the term “regulatory compliance.” But what does that mean for your company? We explored seven principles of HACCP for regulatory compliance and showed you how to unlock the potential benefits that can come from implementing them in your business.

By learning about and understanding these principles, you can ensure that your company operates within applicable legal guidelines and avoids potential fines and other penalties. You can create a strong foundation for future growth and success with a little effort. If you want more clarification on this subject, you can find HACCP or PCP regulatory experts to help you!

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

30 Minute Free Consultation
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5 FDA Warning Letters: Food Manufacturers of CBD Food Products

Introduction

On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning letters to food manufacturers who were selling products containing cannabidiol (CBD). These letters were issued in response to an online search for companies selling foods or beverages containing CBD as a continued FDA CBD enforcement trend.

FDA warning letter to Food Manufacturers of CBD food products

The FDA has made it clear that CBD is not an approved food additive, and it cannot be added to foods or drinks, including animal feed. Two of the warning letters targeted companies marketing products that were labeled as dietary supplements. The FDA emphasized that even if a product is marketed as a dietary supplement, it does not change how it will be evaluated by the agency.

The letters outline 2 major compliance violations:  To learn more about CBD regulations click here:

  1. FDA stated that there is insufficient evidence to demonstrate that CBD could be generally recognized as safe (GRAS) for its intended use. With no GRAS pathway available, CBD can only be approved as a food additive, requiring premarket approval. Currently, there is no food additive regulation that authorizes the use of CBD.
  2. The fact that CBD was sold as an unapproved new drug was in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. This “drug preclusion” clause was invoked because the drug product Epidiolex containing CBD as its active ingredient, was first approved as an Investigational New Drug (IND) for the treatment of Dravet Syndrome.

Warning letters regarding cannabidiol (CBD).

There are companies that have been marketing food and dietary supplement products which have been making claims that their CBD-containing products treat and prevent various diseases, including cancer. However, the FDA made it clear that CBD is not an approved food additive, and it cannot be added to foods or drinks, including pet treats. In addition to this, manufacturers should not make any health claims about these products as there is no scientific evidence that supports such claims.

The FDA has been receiving reports from consumers who experienced adverse events after taking certain foods or drinks containing CBD oil over the last few years. These adverse events include severe vomiting and diarrhea which can lead to dehydration or even kidney failure if left untreated for long periods of time; therefore, it’s important for anyone who uses these types of products on a regular basis to contact their doctor immediately if they experience symptoms related with them getting sick after consuming them (e.g.., nausea/vomiting, etc.)

What are the safety concerns?

The use of CBD raises safety concerns, especially with long-term use. Scientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.

What consequences do these companies face?

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

Conclusion

Currently, CBD is not permissible as a food additive or dietary supplement ingredient. The FDA has issued several warning letters to food manufacturers that are selling products containing CBD, which demonstrates the agency’s commitment to enforcing the law and protecting public health.

Quality Smart Solutions can help food manufacturers of hemp extracts for dietary supplements and food labeling to ensure its compliant with FDA rules, regulations, and guidance documents.  We’ll help you through every step of the clinical trial design and execution and can also help with food products to obtain Generally Regarded as Safe (GRAS) status.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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Safe Quality Food Certification SQF Facility Certifications

Food is one of the most important parts of our lives. We eat it to stay alive, and we eat it to enjoy life. Unfortunately, foodborne illnesses are a major issue in Canada, taking a toll on our health and economy.

Safe Quality Food Certification SQF Certification Cost, SQF Facility Certifications

One way to reduce the risk of foodborne illnesses is to certify your food as safe. There are a number of ways you can do this, from using compliant labelling to using independent certification services.

This blog post will explore the different food safety certifications and how they can benefit your business.

What is SQF Certification?

Safe Quality Food Certification is a program that establishes and maintains food safety standards. This certification is specific to the manufacturing of safe food products, according to the SQF website.

To obtain SQF certification, a company must meet certain safety and quality standards set by the organization. These standards cover everything from production processes and handling of ingredients to storage and packaging. Companies that meet these requirements can display the SQF logo on their products.

SQF certification is important because it assures consumers that the food, they buy is safe and of high quality. It can also help companies attract new customers and increase profits.

How to get SQF Certification?

If you want to get certified as a safe quality food producer, the Safe Quality Food Certification (SQF) program is one of the options available to you. SQF certification is an internationally recognized standard that regulates the production and handling of food products.

To become certified, you must first pass an audit that covers topics such as food safety management systems, hazard identification and analysis, and cleaning and sanitation practices. Once you have passed the audit, you will be issued an SQF certification certificate.

Need help with your GFSI or SQF Certification process?

If you are interested in becoming certified, there are several things to keep in mind. First, ensure your business can meet the standards required for certification. Second, make sure your food safety management system is properly implemented. Finally, make sure your cleanliness and sanitation practices are up to par. If you can meet all these requirements, becoming certified with SQF should not be too difficult.

What is the SQF Certification Process?

The World Health Organization developed the Safe Quality Food Certification (SQF) program to help ensure the safety and quality of food products. The SQF program is a system for monitoring food quality and safety. The program is divided into three phases: pre-certification, certification, and re-certification.

Pre-certification involves verifying that a company has met certain standards and requirements related to food safety management. To be eligible for pre-certification, a company must have an adequate food safety management system.

Certification is the first step in the SQF process. Companies must pass a comprehensive audit that tests their compliance with established food safety standards. After the audit, companies are designated with an “SQF Level 1” or “SQF Level 2” certification.

Re-certification is required every five years for all companies certified at SQF Levels 1 or 2. Re-certification allows companies to demonstrate their continued compliance with established food safety standards. Companies must submit documentation demonstrating their adherence to current regulations and plans for continuous improvement in food safety management procedures.

The SQF certification process can be time-consuming and costly, but it assures that the food products you purchase are safe and high-quality.

What are the benefits of SQF Certification?

SQF certification is a globally accepted quality system that ensures food products’ safety, quality, and environmental compliance. SQF certification is mandatory for many companies in the food industry and has been found to be beneficial in terms of product safety, quality assurance, and market share.

The benefits of SQF certification can be summarized as follows:

  1. Improves product safety.
  2. Enhances quality assurance.
  3. Increases market share.

SQF Certification Cost

Certification costs vary depending on the certification body and program. The Safe Quality Food Certification (SQF) is a global, voluntary program administered by the International Organization for Standardization (ISO) and offers certification to organizations that meet specific quality requirements. SQF certification is valid for five years and requires annual renewal. Organizations with SQF certification can use the certified logo on their products and promotional materials.

The SQF program has two levels: Level 1 certification recognizes organizations that have implemented specific quality management systems (QMSs) in their operations, while Level 2 certification identifies organizations that have excelled in implementing QMSs across all aspects of their business. Organizations may also become certified in more than one area, such as safety and environmental responsibility.

To qualify for Level 1 or Level 2 certification, an organization must meet ISO/IEC 17025:2005 standards for QMSs. To maintain certification, an organization must continue compliance with its QMSs through periodic audits or other forms of oversight.

In order to be eligible for SQF certification, an organization must also comply with ISO 9001:2008 standards for quality management systems. In addition, most organizations seeking Level 1 or Level 2 certification must also comply with ISO 14001:2004 environmental management standards.

The cost of becoming certified varies according to the type of program desired and the number of areas in which the organization wishes to certify itself.

What are SQF Facility Certifications?

Safe Quality Food (SQF) Facility Certifications are the global standard for identifying and certifying organizations that produce safe food. SQF is a voluntary, non-profit organization developing globally accepted principles and practices to help improve food safety.

The SQF Foundation works with member companies that meet rigorous criteria to certify their facilities. Facilities must complete an extensive assessment process, including documentation and sampling of production processes. Certification can be earned by either Member Companies or Third-Party Assessors, depending on the type of facility being certified.

Third, Party Assessors can issue certificates for various operations such as slaughterhouses, agriculture production, processing plants, bakery production, and cold storage facilities. Member Companies certify their entire operations or specific areas, such as product safety, environmental management, or quality control procedures.

There are over 900 SQF Certified Organizations in more than 100 countries worldwide.

Conclusion

As business owners, it’s important to ensure your food is of safe and quality variety. Food certification can help you achieve this goal by assessing the production process for your food items and ensuring that they meet specific safety standards.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

30 Minute Free Consultation
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FDA UDI Labeling Requirements for FDA Class 1 Medical Device

Class 1 Medical Device FDA

 

FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand overview, you’ll gain insight into the prerequisites for device categories, UDI labeling requirements, and more.

With the proliferation of medical devices worldwide, it is important to stay on top of applicable UDI labeling requirements. This guide will explain the global regulatory standards for Unique Device Identifiers (UDIs) and other important information about UDI labeling and usage.

Introduction:

The FDA in July 2022 updated its guidance documents on Unique Device Identifier requirements (UDI). That guidance document now reflects the Global Unique Device Identification Database (GUDID) submission requirements for select class 1 medical devices.  FDA considers these products to be classified as consumer health products and therefore doesn’t enforce GUDID requirements for these medical devices when their labels must have a UDI.

Class I devices that FDA does not consider to be consumer health which is typically used in healthcare settings and are often subject to additional regulatory controls, such as the requirement to submit a premarket notification. For these devices, FDA has determined that submission of UDI data into GUDID is required as submission of UDI data into GUDID for these devices may also help reduce medical errors and simplify the integration of device use information into data systems.

Overview of Class 1 Medical Device FDA Regulations:

  1. Know Your Pre-Market Requirements-  Before you can even start the market entry process for a Class 1 medical device, you must have the right prerequisites in place. These include confirming the product is in an appropriate category (such as general or hospital use) and understanding the labeling requirements of your product before submitting it. Additionally, if you’re using third-party test results, they must be approved by FDA personnel before they’re submitted with your device application.
  2. Understand the Proper Labeling Requirements- Labeling is a big part of class 1 device market entry. You must include the information required by FDA so consumers can understand how to use your product safely and effectively. This includes basic information such as the product name, intended purpose, hardware components, and identification/serial numbers. Additionally, you may be required to provide prominent health hazard warnings depending on the use of your product. It’s important to pay attention to these labeling requirements when preparing for a Class 1 device submission.
  3. Research Ban Laws & Rules in Your State- Before entering the Class 1 device market, you should research the laws and regulations set by the FDA in your state. You should also become familiar with any unique requirements that may apply to your device type. Additionally, be sure to read up on pre-market requirements for medical device manufacturers operating out of different states as these will differ. Understanding your FDA state-specific requirements is essential when planning a successful Class 1 medical device submission.
  4. Ensure Compliance with Quality Systems Regulations (QSR)- All FDA-regulated manufacturers must comply with the Quality System Regulation (QSR), which is comprised of 21 CFR 820, by developing and maintaining an effective quality system that describes how you will comply with requirements. The QSR includes the establishment and maintenance of a system for design control, including established design specifications and accurate record-keeping. When planning your product launch, ensure that all documentation meets QSR requirements to avoid costly delays or rejection from the FDA when making registration or listing submissions.

  5.  Determine If FDA 510(k) Clearance Is Necessary- Before embarking on the Class I medical device FDA regulatory pathway, consult with the FDA to determine if 510(k) clearance is needed. Most Class I devices are exempt from premarket notification (510(k)) unless they are listed in a class II or III device classification. Determine whether any of your product’s intended uses or technological characteristics cross over into the parameters of higher-risk categories, and update your device’s labeling accordingly.

Understand Global UDI Regulations:

Understanding the global UDI regulations will help with compliance and ensure that your medical devices are properly labeled. Regulations differ from region to region, so it is important to familiarize yourself with the applicable rules which may include labeling requirements, a timeline of implementation deadlines, and registration systems for reporting UIDs. In addition, depending on jurisdictions like the United States Food & Drug Administration (FDA), there may be further stipulations or exceptions specific to your region.

Label All Products With UDI Markings:

One key requirement of UDI and UID systems is the label marking system for products. Different countries may have different standards and formatting for label markings, but the basics remain the same: all products must have a plain-text label marking with at least one basic data element (e.g., trade name, product identifier) along with the UDI notation in either human- or machine-readable format.

What is the FDA Unique Device Identification (UDI) system?

The FDA’s Unique Device Identification (UDI) system is a critical component of the Federal Drug and Cosmetic Act (FD&C Act). The purpose of the UDI system is to provide a way for any person or business that manufactures or imports devices to identify each device they make, import, or offer for sale. This identification provides public health officials with crucial information about the device, which helps them track potentially harmful devices and make sure that approved devices are safe.

The FDA has historically required all Class 1 devices to be labeled with a UDI but recently expanded its requirements to include all Class 2-6 devices as well. This article will discuss how this requirement works in practice and what you need to do as an importer or manufacturer to comply with these new regulations.

The UDI System

The UDI System is a unique identification system for medical devices. The UDI consists of two parts: A Device Identifier (DI) (a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device)

  • A Production Identifier (PI):  a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
    • Lot or batch number within which a device was manufactured
    • Serial number of a specific device
    • Expiration date of a specific device
    • Date a specific device was manufactured;
    • Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

The device labeler must provide the UDI in two forms on labels and packages:

  • Easily readable plain text
  • Machine-readable form that uses automatic identification and data capture (AIDC) technology.

To develop a UDI, device labelers must contact one of the issuing agencies accredited by the FDA. Contact an FDA-Accredited Issuing Agency for details.

When are the UDI Rule requirements?

According to the medical device categorization, the FDA published a final rule in September 2013 establishing the UDI system.  The rule included compliance dates ranging from September 24, 2014, to September 24, 2020.

The UDI rule mentioned the following requirements:

  • Unless an exception or alternate is applicable, a device must have a UDI on its label and packing.
  • Stand-alone software that is governed as a device requires special labelling.
  • GUDID, the FDA’s repository for device safety information, requires data submission regarding any device that must have a UDI.
  • Specific dates must follow a defined format on device labels.

 

UDI Database Requirements:

The FDA requires that class 1 medical devices which are typically used in healthcare settings bear the UDI on their packaging. This is a 12-digit number that is a combination of DI and PI. . Manufacturers must register with the FDA by submitting information about the company name, location, contact information, etc., to get an authorization code that will allow them to submit UDI information for their own devices or those made by third parties.

The manufacturer generates this unique code when they register with the FDA and then uses it each time they submit data about medical devices through their system; this means there can be multiple codes associated with each device if it changes hands between manufacturers or is exported from one country into another.

What is a Class 1 Medical Device?

A Class 1 medical device is a device that has not been shown to present risks beyond those associated with the basic safety and performance characteristics generally accepted for non-medical products. Examples of Class 1 medical devices include wheelchairs, tooth-cleaning kits, and hearing aids. Some Class 1 medical devices are exempt from regulatory requirements set out by the FDA.

What are the Regulations for Class 1 Medical Devices?

Class 1 medical devices, while exempt from most FDA regulations, must still comply with essential principles of safety and performance. This means that manufacturers of Class 1 devices must demonstrate compliance with controls in the US and international standards of good manufacturing practice (GMP). Manufacturers of Class 1 medical devices must also ensure that their products are labeled appropriately, including a description of the device’s intended use, pertinent warnings, and instructions for use.

What Documentation is Required to Manufacture a Class 1 Medical Device?

For Class 1 medical devices, the manufacturer must create a device master record (DMR) including documents such as design drawings and specifications, materials used in device production, processes used to manufacture the device, an identification of all parts of the product and their functions, instructions for use and storage, a description of the testing procedures performed during production, along with results documentation. In addition, manufacturers must also document records that demonstrate compliance with quality systems requirements.

How Does a Company Ensure its Class 1 Medical Devices Meet Quality Standards?

To ensure that their Class 1 medical devices meet quality standards, manufacturers must adhere to the Quality System Regulation (QSR). This requires companies to develop and implement a robust quality system that meets the requirements specified in the QSR.

The QSR outlines specific design control, production and process control, inspection or verification, nonconforming product evaluation, and corrective and preventive action processes. By following these regulations, manufacturers can ensure that their medical devices meet safety standards before bringing them to market.

FDA UDI Requirements for Class 1 Medical Devices

The FDA classifies devices into 3 classes: Class I, II, and III. These classifications allow the FDA to determine how much risk a product poses and how heavily it should be regulated. You can read more about each.

In general, the UDI submission requirements are different between these categories because they are considered to have different risk levels (i.e., higher for Class III). However, there are some similarities in their requirements as well: Namely, all devices must be registered in GUDID at least 30 days before distribution begins to avoid noncompliance penalties from the FDA after submitting your UDI information through MDRx.

Understanding FDA UDI Requirements is a great start to making sure you are fully compliant with medical device regulations:

By now, you’ve probably been bombarded with UDI requirements for class 1 medical devices and perhaps even class 3 devices. The GUDID submission deadlines are fast approaching, so it is important to understand what the FDA UDI requirements are for each type of product.

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) which required that every device include a unique device identifier or UDI. This act was created after years of poorly managed recalls and devices being used in procedures without any knowledge about their safety record.

It was designed to increase transparency between healthcare providers and manufacturers by providing better information about the safety of medical devices that are being used on patients.

What is the GUDID Database?

The GUDID (Global Unique Device Identification Database) is an essential tool for both healthcare providers and manufacturers of medical devices. This database allows manufacturers to register device information and provides up-to-date access to healthcare professionals to ensure the safety, quality, and effectiveness of the products they use. 

The GUDID is managed by the U.S. Food and Drug Administration (FDA) and is a secure, centralized repository decentralized of device identification information submitted by medical device manufacturers. This data is updated regularly to ensure accuracy, traceability, and readability, which helps healthcare providers make informed decisions about their device selection and use. Also, by submitting device information to the GUDID, medical device manufacturers can comply with FDA regulations.

How can the GUDID database help you?

Making full use of the GUDID database can have many advantages for both medical device manufacturers and healthcare providers. For example, the unique identifier provided by GUDID makes it possible to identify a device with accuracy, traceability, and readability information. Additionally, GUDID data provides healthcare providers with essential guidance for usage and disposal instructions for medical devices at the end of their profile information. Furthermore, medical device manufacturers can also benefit from access to timely updates on any changes made to their devices’ profiles or FDA-regulated recall status.

How to Search the GUDID Database?

The GUDID database makes it easy to quickly lookup a device. All you need is either the name of the device or its Universal Product Code (UPC). You can find the UPC on or near the product’s packaging. Once you have identified the product, click on it in the GUDID search results to access information such as medical device descriptions and instructions, actions performed by the manufacturer, and any known recalls related to that particular item.

How to Optimize the Performance in the GUDID Database?

You can easily optimize your performance in the GUDID database by learning how to use its most helpful features. To create accurate, up-to-date device information, you’ll want to take advantage of GUDID’s bulk submission capabilities, label augmentation services, and report tracking tools. Additionally, it’s important to remain vigilant about managing data accuracy – always double-check prior submissions and confirm current device versions are accurately listed within the system.

GUDID Submission Timelines

The GUDID submission timeline and process have been designed to ensure that the UDI is assigned within 12 hours of the time of submission and that a labeler has access to all relevant information in one place at all times.

The steps are as follows:

  • Submit your device record (DR) or modification to FDA’s Global Unique Device Identification Database (GUDID).
  • Within 12 hours after submitting your DR/modification, check the status of your DR/modification on the GUDID portal and review any errors reported by FDA for resolution. Once resolved, please upload your corrected version of your DR/modification. If no corrections are needed, proceed directly to Step 4 below: Labeler Notification Reassignment Letter (LRARL) generation.
  • Upon successful completion of these activities outlined above, you will receive an LRARL from FDA via email with instructions for downloading labels from our CDRH Labeling Information Management System website—the same site where labels were previously downloaded using CDRH’s legacy Labeling Information Management System (LIMS).

Submitting Information to the Global Unique Device Identification Database (GUDID):

Device labelers are required to submit information to the FDA-administered Global Unique Device Identification Database (GUDID). GUDID includes a standard set of basic identifying elements for each device with a UDI and contains ONLY the device identifier (DI), which serves as the key to obtaining device information in the database. GUDID does not include the production identifier (PI).

To submit information to GUDID, the device labeler must first request a GUDID account.

Conclusion

The UDI system is a great way to make sure that medical devices are properly tracked and identified. It helps ensure that they are not misbranded or adulterated, which could lead to serious harm or injury to patients. The FDA has made it clear that all Class 1 Medical Devices must be registered before being sold in the US. You should always be aware of your responsibility as a manufacturer when dealing with UDI requirements for any class of device, as well as understand how FDA UDI regulations apply specifically for each class level.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: 

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Canadian Medical Device Classification (MDALL, MDL & MDEL Listing)

medical device classification in canada

How Medical Devices are Classified in Canada

Regulatory Classification Basics for your Medical Device: 

There are certain rules that apply to a medical device classification, and it varies between different regulatory agencies. The classifications are related to the perceived risk of the product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.

Why does Regulatory Classification even matter for my Medical Device?

Knowing how your medical device is classified matters so that we can determine what is required to be done before the medical device is sold in Canada. Furthermore, the classification determines how the product is to be designed and what controls are required. Lastly, timelines around what it would take to bring your device to market and costs can be estimated once the device class is determined.

Medical Device Classification in Canada (MDALL, MDL, MDEL)

The medical devices regulations in Canada are established by the Government of Canada and regulated by Health Canada. There is a risk-based classification system defined by Health Canada for non-in vitro diagnostic (non-IVDDs) medical devices:

  1. Invasive Devices (Rules 1-3)
  2. Non-Invasive Devices (Rules 4-7)
  3. Active Devices (Rules 8-12)
  4. Special Rules (Rules 13-16)

For each of the broad categories, there are a set of rules that apply.  Manufacturers should follow these rules to determine the risk classification of their medical devices. For example, you are interested in marketing a percutaneous catheter in Canada. After reviewing the Risk-Based Classification System for non-IVDDs, we would determine for you that the percutaneous catheter is an invasive device. To classify the device, we’d review all the options and conclude that Rule 1 applies for you. Further, based on the intent of use, the medical device is classified as a Class II medical device in Canada. There are similar risk-based classification systems for in vitro diagnostic medical devices and Software as a Medical Device (SaMD).

Medical Device Licence (MDL) in Canada

Overall, there are four levels of medical device classifications based on the level of risk (low to high) in Canada: Class I, Class II, Class III, and Class IV.  Before going to market in Canada, a manufacturer must first apply for a medical device license (MDL).

Class, I medical devices do not require a license. There are different applications for Class II, Class III, and Class IV medical devices, and the application complexity increases as the risk classification increases.

There is a keyword index document available to assist manufacturers in verifying the class of medical devices is an alphabetical listing of all the short descriptors for devices that are entered into the medical devices system. This document contains synonyms and industry words that are used to describe these devices, along with their respective classifications.

Need MDALL, MDL, MDEL Registration & Listing Health Canada Assistance

 

Manufacturers of Class II, III, and Class IV medical devices can receive their MDL license by submitting a premarket application.  This can be in either the ToC or Health Canada formats, for entering the Canadian market. Additionally, the manufacturers should obtain an ISO 13485 certification with Medical Device Single Audit Program (MDSAP).

Medical Device Active Licence Listing (MDALL)

Once Health Canada approves the Medical Device Licence, the device information is maintained in the Medical Devices Bureau database for Class II, Class III, and Class IV devices. Class I medical devices do not require an MDL as they are monitored by the Health Products and Food Branch Inspectorate through establishment licensing.

The MDALL online query allows you to search for medical devices with an active MDL. A search can be done by company name, company ID, license name, license number, device name, and device identifier.  A device identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. The catalog number of the device is often selected for this purpose.

Medical Device Licence Renewal in Canada

The medical device license renewal process in Canada has two purposes.  The first is to confirm whether the medical device will continue to be sold in Canada and whether the medical device license will remain active.  The second is to collect information that must be assessed prior to invoicing for market authorization.

Manufacturers of medical devices that are licensed for sale in Canada are required to inform Health Canada each year before November 1 that the information submitted with their license application and any subsequent amendments have not changed. This is referred to as the medical device license renewal process. Manufacturers of licensed Class II, III, and IV medical devices are charged an annual fee, payable at the time of license renewal, for the right to sell their devices in Canada. The fee is charged annually for the twelve-month period beginning on November 1 of each year. Manufacturers must notify Health Canada if there is a change regarding the regulatory correspondent or contact information previously submitted. Failure to do so may result in the cancellation of your medical license.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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Medical Device License (MDL MDEL SaMD) Under the Microscope

 

The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence (MDL) and the Medical Device Establishment Licence (MDEL) are the licenses issued by Health Canada, the Health Agency that regulates the medical devices sold in the Canadian market.

Medical Device License MDL MDEL SaMD

These licences are referred to as “medical device” and “medical device establishment,” respectively. In the Canadian market, medical devices are separated into four different classes: Class I, Class II, Class III, and Class IV.

Devices that fall into Classes II, III, and IV are eligible to receive Medical Device Licenses (MDL). In contrast, establishments that manufacture Class I medical devices are eligible to receive Medical Device Establishment Licenses (MDEL). In addition, the MDEL is granted to importers and distributors of all device classes.

A medical device license is a type of intellectual property (IP) license issued by Health Canada to authorize a manufacturer to sell its medical device in Canada.

Medical Device License (MDL) – Common License

It is a license required for a company to manufacture, import, distribute and sell medical devices in Canada.

A medical Device License (MDL) is a permit or license to sell medical devices. Health Canada issues this license. Furthermore, it is a requirement for all medical device manufacturing. Getting MDL becomes easy when you proceed with a reliable platform.

Medical Device Establishment License (MDEL)

Medical Device Establishment License (MDEL) is the document that provides evidence of compliance with the Medical Devices Regulations. The Medical Device Establishment Licence (MDEL) is an authorization issued by Health Canada under the authority of the Food and Drugs Act, which authorizes an establishment to manufacture or import/distribute a medical device.

The MDEL also authorizes an establishment to manufacture or import/distribute software that performs medical functions (SaMD). Health Canada regulates all medical devices that are marketed in Canada.

Renewal of MDEL and MDL

Before April 1 of each year, the MDEL goes through an annual review, and before November 1 of each year, the MDL for each device class goes through a renewal process. The application for the initial licence and the application for renewing an existing licence are both different from one another.

It is imperative to select the appropriate application in order to prevent any potential delays in the review process by Health Canada. Quality Smart Solutions has the knowledge and experience to successfully manage and complete the projects required by the Canadian Medical Device Regulator.

Do you need MDL, MDEL, or SaMD Assistance?

 

Software as a Medical Device (SaMD)

The software industry contributes significantly to the advancement of the healthcare sector. Any software product’s functionality, as well as the manner in which it is represented or labelled for use, determines whether it can be considered a medical device in accordance with the regulations set forth by Health Canada.

Software as a Medical Device (SaMD) is software that monitors or treats human health. Software as a Medical Device (SaMD) is software that has been demonstrated to meet the regulatory requirements of Health Canada’s Medical Devices Program. It can be used instead of an MDL but not in addition to an MDL.

Software as a medical device (SaMD) is a regulatory term used in Canada to describe the approval process for the software that performs medical functions. SaMD is also used as an electronic device offering healthcare services. SaMDs can be used to diagnose, treat, or prevent illness or injury.

Health Canada Medical Device and Quality Management System Requirements

It is essential to get a basic understanding of the whole procedure. It will not only make things easier for you but it will also save you time and money.

When applying for an MDL, you will also be required to demonstrate that you have a quality management system that is certified to ISO 13485 and is in compliance with the Medical Device Single Audit Program (MDSAP).

This demonstrates that your organization is able to fulfill the specific requirements outlined in the Canadian Medical Devices Regulations (CMDR).

Difference

Knowing the difference between MDL, MDEL, and SaMD licenses is essential because they are not interchangeable. However, these terms and licenses are required for different purposes.

The MDL is a license that is required for medical devices. It enables the manufacture, distribution, and sale of medical devices in the United States. This article will explain what the MDL is and what it does.

The MDEL is a Health Canada regulatory classification for medical device establishments. The MDEL licence is an establishment licence, which means that the holder of this licence is permitted to manufacture, import, and distribute medical devices within their specific establishment. This licence is usually granted to businesses that are involved in the production or distribution of medical devices.

The MDEL licence is an important qualification for businesses who want to produce or distribute medical devices. It allows these businesses to operate under strict safety and quality guidelines, and it also allows them to sell their products in a regulated market.

SAMDs are software that act as a medical device. The creation of software for medical devices is one of the areas of the healthcare industry that is expanding at the quickest rate.

Does Canada require that international producers have a local representative in the country?

No. In the case of medical devices, Health Canada does not mandate that a local representative be present. Applications for medical device registration can be submitted by foreign producers, and those applications can be held.

My device has FDA authorization; is there a fast-track for additional markets?

The approvals obtained in other countries are not recognized by Health Canada, and as a result, they do not provide you with any major advantages throughout the approval process. On the other hand, if an application is turned down in another jurisdiction, it can hurt the chances of getting it approved in Canada.

Because a significant portion of the material that must be provided for submissions to Health Canada is the same as that which must be provided for an EU technical file or a US 510(k), having these could potentially reduce the amount of time spent.

Conclusion

The MDL vs MDEL vs SaMD landscape is a complex one, but hopefully this article has given you a better understanding of the differences between these three types of medical devices licences available in Canada.

All medical devices imported into or offered for sale in Canada are subject to the Medical Devices Regulations (the Regulations). These were written with authority granted by the Food and Drugs Act (the Act). The Regulations outline the requirements that must be met for medical devices to be legally imported into Canada, sold there, or advertised there.

We hope you have now grasped the idea of all three terms (MDL, MDEL & SAMD). If you still have questions, feel free to ask the experts now.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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CFIA Enforcement of Nutrition Facts Table & Food Labelling

 

The Canadian Food Inspection Agency (CFIA) is responsible for protecting Canadians’ health and safety by ensuring that food that reaches customers is safe, nutritious, and correctly labeled. The CFIA’s responsibilities also include enforcing federal food safety and nutrition regulations.

Nutrition Facts Table CFIA

As of July 1, 2016, the CFIA has begun to enforce the new Nutrition Facts Table (NFT) and food labeling regulations. It means that all food products sold in Canada must now comply with these new rules.

If you are a food manufacturer, importer, or retailer, it is important to understand these changes and how food labeling links your business with your customers. This blog post will provide an overview of the new NFT and food labeling requirements, as well as some tips on how to comply with them.

Overview of the CFIA’s Enforcement Process

The Canadian Food Inspection Agency (CFIA) ensures that food products sold in Canada are safe and properly labeled. The CFIA enforces federal food safety and labeling laws, such as the Food and Drugs Act and the Safe Food for Canadians Act.

The CFIA’s enforcement process begins when it receives a complaint or information about a possible violation. The CFIA will then investigate to determine if there is a federal law violation. If a violation is found, the CFIA will take appropriate enforcement action, including issuing a warning, recalling a seizure order, or prosecuting the offender.

The CFIA takes food safety and labeling violations seriously and will not hesitate to take enforcement action when necessary. However, the CFIA also recognizes that many unintentional violations can be corrected quickly and easily. In these cases, the CFIA may provide guidance to help businesses comply with the law.

Nutrition Facts Table and CFIA Changes

The Nutrition Facts table is a mandatory component of food labels in Canada. It must be easy to read and understand and provide information on the following nutrients: calories, fat, saturated, trans fat, cholesterol, sodium, carbohydrates, fiber, sugars, and protein. The table must also include each nutrient’s percent daily value (%DV).

The %DV tells you the percentage of each nutrient in a single serving in terms of the daily recommended intake. For example, if the %DV for sodium is 4%, then one serving of that food contains 4% of the daily recommended intake for sodium.

 

Recently, Canadian officials have made many changes to the nutrition fact table. Some of them are the following.

  1. Potassium has been included in the previously mentioned list of nutrients because of its significance in maintaining normal blood pressure. The majority of people in Canada do not consume sufficient amounts of this essential nutrient.
  2. Omit vitamin A and vitamin C because the diets of most individuals in Canada provide an adequate amount of these nutrients.
  3. Adding the levels of potassium, calcium, and iron that are measured in milligrams (mg)
  4. Including a footnote at the table’s bottom regarding the percentage of the daily value
  5. Consumers will have an easier time understanding how much sugar and other nutrients (like sodium) are in their meals if this information is provided, and it will explain that: A little amount would be 5% or less.
  6. The Nutrition Facts table can help you make wise and informed choices about the foods you eat. Use it to compare similar products and choose the one that best meets your nutritional needs.

Food Labelling

According to the Canadian Food Inspection Agency (CFIA), food labels must include certain information to help consumers make informed choices about the foods they purchase. The CFIA is responsible for enforcing these requirements and ensuring that food labels are accurate and up-to-date.

The Nutrition Facts table is one of the most important parts of a food label, as it provides information on the nutrient content of a food. The CFIA requires that all packaged foods sold in Canada include a Nutrition Facts table on their label.

The CFIA also regulates other aspects of food labeling, such as claims about a product’s benefits, ingredient lists, and nutrition claims. For example, claims such as “low fat” or “high in fiber” must meet specific criteria for a food label.

The CFIA has published several resources to help the industry comply with food labeling requirements, including a Guide to Food Labelling and Advertising and a toolkit for small businesses.

How does the CFIA Enforces the Regulations?

The Safe Food for Canadians Act and Regulations have rules about how food labels should look. The Canadian Food Inspection Agency (CFIA) makes sure these rules are followed. The CFIA verifies that the industry complies with the regulations through various activities, such as inspections, audits, and investigations. Food Labelling Links consumers with safe food.

If the CFIA finds that a company is not in compliance with the food labeling regulations, it may take enforcement action. Enforcement actions can range from issuing a warning to ordering a recall of the products in question. The CFIA also has the authority to issue fines and prosecute companies that do not comply with the law.

The CFIA takes food labeling violations seriously and will not hesitate to take enforcement action when necessary. The industry should be aware of the Safe Food for

Conclusion

The CFIA’s enforcement of the Nutrition Facts Table and food labeling is important in ensuring Canadians have access to accurate and up-to-date information about the foods they eat. This will help them make informed choices about the foods they purchase and ultimately lead to healthier eating habits.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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FSVP Compliance: Regulatory Assessment Record Keeping

 

U.S.A RRA FDA Draft Guidance:

In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation of Remote Regulatory Assessments (RRAs). Questions and answers outlined the regulatory oversight during and after the COVID-19 pandemic. 

FSVP Compliance Record Reviews

The draft, “Conducting Remote Regulatory Assessments: Questions and Answers,” outlines the FDA’s use of RRAs to continue regulatory oversight in the short and long term. The draft guidance states that RRAs, which allowed FDA to assess an establishment’s compliance while there were travel restrictions, have been proven.  The FDA has determined that continued use of RRAs will benefit the post-pandemic world and across all FDA-regulated industries.

Remote Regulatory Assessments:

RRAs are optional in some situations, while they are required in others. For American food importers participating in the Foreign Supplier Verification Program (FSVP), RRAs are required. Establishments must make sure that the necessary FSVP documents are kept properly, in English, and easily accessible to FDA when it is implementing RRAs to evaluate their compliance because record-keeping is a crucial component of FSVP compliance.

Businesses that only import products are not regarded as facilities unless they also manufacture, process, pack, or store food. However, rather than FSVP for US importers, FDA would instead examine for compliance with the Supply Chain Program under 117 (like FSVP for food facilities).

FDA FSVP Record Reviews (FSVP Rule):

A range of activities for which the FDA may use multiple terminologies, but that are all deemed to be forms of RRAs, including remote interactive evaluations and remote record reviews, according to the FDA.

According to the FSVP rule, each imported product from each supplier must be supported by paperwork that shows FDA food safety compliance.

The FSVP needs to be updated at least every three years, or if important supplier/product information changes, such as the facility’s address, or when a new ingredient or procedure is added that has an impact on the hazard analysis or other FSVP evaluations.

Do you need help getting your FSVP certification?

 

FDA Timeframes for Establishment FSVP Records:

FDA assesses each situation individually before determining the required timeframe for an institution to submit records for a required RRA. However, importers are required by the Federal Food, Drug, and Cosmetics (FD&C) Act to deliver FSVP records “promptly to the FDA upon request.” The records must be supplied electronically or in another way that enables fast delivery when the FDA makes a written request for them.

The FDA Compliance Officer will ask for the records to be submitted using the FSVP Importer Portal for FSVP Records Submission during RRAs. The portal will ask importers to register for an account and upload the required FSVP information.

The documents need to be arranged and identified correctly. They might also be emailed in at other times. FDA is a legally recognized organization and will request physical records at the importer’s business headquarters.

What are the FSVP Non-Compliance penalties?

FDA may refuse a U.S. importer’s food imports at the U.S. port of entry (21 CFR 1.514(a)), and the importer may be in violation of section 805 of the FD&C Act if they don’t answer to the FDA’s request for FSVP reports. Among the behaviors that FDA may deem as declining to engage in a mandatory RRA are actions like withdrawing participation and refusing to give FDA access to records.

Additionally, FDA will issue a Form 483, summarising the inspectional observations, if violations are discovered during an FSVP inspection. FDA will publicly issue a Warning Letter, which can progress to issuing a public Import Alert 99-41 if an importer does not respond and take corrective steps within 15 days.

Once an Import Alert is issued, the FDA will detain an importer’s violative food shipments without the need for physical examination. This effectively can shut down an importer’s business.  Therefore, it is critical that your FSVP certification is done properly to avoid non-compliance penalties.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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Canada Cosmetic Regulations: Cosmetic Notification Form (CNF)

 

Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF)

Canada is one of the most popular tourist destinations in the world, and it’s no surprise that the country has some of the most stringent cosmetic regulations in the world.

Cosmetic Notification Form (CNF)

In this blog post, we’ll look at some of the top Canadian cosmetic regulations and what you need to do if you want to sell products in Canada. From ingredient lists to packaging, read on to learn everything you need to know about selling products in Canada.

What is a Cosmetic Notification Form?

A Cosmetic Notification Form (CNF) is a document that must be submitted to Health Canada before you commence the distribution of a cosmetic product in Canada. The person responsible for distributing the product must be listed on the cosmetic notification form. You must also include information about the product, such as its name, ingredients, and intended use.

To ensure that your cosmetic products are safe and meet Canadian safety standards, you must first submit a CNF to Health Canada. It will help Health Canada to ensure that your products are safe before they’re released to the market.

The CNF is important because it allows Health Canada to track any safety issues with your product. If Health Canada identifies any issues, they will reach out to you with corrective actions that will be required prior to continuing the sale of your cosmetic products.

If you want to distribute a cosmetic product in Canada, you must first submit a CNF to Health Canada.

What are the Cosmetic Notification Form Requirements?

The cosmetic notification form (CNF) is a document that cosmetics manufacturers in Canada must submit to Health Canada before they market their products. The CNF is an electronic registration form that must be submitted to the department prior to sale in Canada.

The CNF requires information such as the name and address of the manufacturer, the product ingredients, the product name, product form, and area of intended use.

The Cosmetic Notification Form requirements became effective on January 1, 2009. All cosmetic manufacturers wishing to market their products in Canada must register with Health Canada using the CNF.

How to File a Cosmetic Notification Form?

If you are selling a cosmetic product in Canada, you must file a Cosmetic Notification Form (CNF). You can file the form with the government agency that regulates cosmetics in Canada. The form requires information about the product, ingredients, and any manufacturers/distributors.

The CNF is used to:

  • Stop non-compliant products from being released into the environment
  • Check for safety issues with cosmetic products
  • Track products and their ingredients

You can find more information about filing a CNF on the Health Canada website.

Who Must File a Cosmetic Notification Form?

Cosmetic manufacturers and distributors must file a Cosmetic Notification Form (CNF) if they import, distribute or sell any cosmetic product in Canada that is not currently authorized for sale in Canada. The Cosmetic Notification Form must be filed with Health Canada before the cosmetic product can be sold in Canada.

The Cosmetic Notification Form must include the following information:

  • The name of the cosmetic product
  • The company name and address of the cosmetic manufacturer or distributor
  • The ingredients of the cosmetic product
  • The country of origin for the cosmetic product

Where Can I File a Cosmetic Notification Form in Canada?

A cosmetic Notification Form (CNF) is a form that must be filed with Health Canada in order to notify the regulator of any changes or updates to the cosmetic product’s ingredients, manufacturing processes, or labeling. The CNF must be filed for all cosmetic products, including personal care products.

To file a CNF, you must fulfil all the requirements. You need someone to help you out on the legal front. Only experts can help and guide you effectively throughout the process. It will make things a lot easier for you.

How long will it take for Health Canada to Process My Cosmetic Notification Form?

Cosmetic products that do not contain any restricted or prohibited ingredients will be processed immediately and a cosmetic number will be issued in 24 – 48 hours. Cosmetics that contain restricted ingredients will follow manual processing by Health Canada. A service standard for manual processing has not been established. 

Conclusion

The Cosmetic Notification Form (CNF) is a document that cosmetic companies must submit to Health Canada before marketing a new cosmetic product in Canada. The CNF includes details about the product, such as its ingredients and intended use, and information on how it will be marketed.

By law, all cosmetics products must contain safe ingredients in order to be sold in Canada.  For tips on how to complete your cosmetic notification form (CNF) click here:

CNF Infographic

How Quality Smart Solutions can help

QSS offers regulatory services from registering your cosmetic products to reviewing your cosmetic labels and submitting a cosmetic notification application to Health Canada.

We also offer FDA cosmetic product compliance solutions for USA Cosmetic Regulations.

Our experts are here to help and offer any cosmetic-related regulatory advice!

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Food Labelling & Health Canada Packaging Update 2022-12-15

 

Health Canada Announcement:

The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and they will apply to packaged foods high in saturated fat, sugars, and salt. A front-of-package emblem will need to be shown on these prepackaged foods in order to comply with the new requirements.

Food products carrying these new symbols are ones that meet or exceed daily amounts of saturated fat, carbohydrates, and salt. It is required that the sign, which is a magnifying glass in black and white with accompanying text, be visible on the front of all packages, that it be situated on the upper right side of the label, and that it be printed in both English and French.

Food Labelling Health Canada Packaging Updates

These new changes represent a significant cost investment for specific businesses operating in various food product segments specifically targeted by the regulations.

The food industry has been given until January 1, 2026, to make this change. However, you may start seeing the front-of-package nutrition symbol earlier.

Compliance Enforcement

The CFIA will begin to check compliance on December 15, 2022, and will use enforcement discretion when non-compliant enterprises have documented plans outlining how they intend to satisfy the new rules as soon as is humanly practicable.

Food labels have updated the list of ingredients and the nutrition data table to reflect these changes. Because of these revisions, the nutrition facts table and the list of ingredients will be improved so that they are simpler to comprehend.

This will assist the people in Canada in making decisions based on accurate information. It was decided to give the industry five years to make the necessary changes to their labels and use up any labels that had already been printed to meet the current requirements.

Despite this, because of the difficulties created by COVID-19, the Canadian Food Inspection Agency (CFIA) has decided that, for the first year, up to December 14, 2022, they would concentrate their efforts on education and the promotion of compliance.

Main sectors affected by these changes.

The changes that have been made to the nutrition facts table are subjected to help make healthier food choices. Now people will have access to more accurate information, and they will be able to know and decide what is good for them.

This transparency will develop trust between consumers and manufacturers as well.

  • Changes to the nutrition facts table
  • Changes to the serving size
  • Changes to the information on sugars
  • Changes to the information on sweeteners
  • Changes to the list of ingredients
  • Front-of-package nutrition labeling

Do you need help with the new Health Canada food labeling and packaging updates?

 

Food items that require symbols and those that do not:

The following are examples of foods that will need to display the symbol:

  1. Generally, prepackaged foods that reach or surpass 15 percent of the recommended value for saturated fat, carbohydrates, or salt are prefabricated (such as deli meats, soups, frozen desserts, or puddings).
  2. Foods sold in a pre-packaged form that includes 10 percent or more of the recommended value for saturated fat, carbohydrates, or salt and have a tiny reference quantity (meaning the amount of food a person generally takes in one sitting) are considered to be high in these nutrients (such as pickles, salad dressings, cookies or breakfast cereals).
  3. Main meals sold in a pre-packaged form with a reference quantity larger than or equal to 200 grams and that meets or exceeds 30 percent of the recommended value for saturated fat, sugars, or salt (such as frozen lasagna, meat pie, or pizza).

A few food items are excluded from this rule:

  1. Foods that are beneficial to one’s health, such as fresh, frozen, canned, or dried fruits and vegetables; 2% or whole milk; eggs; foods that contain a healthy fat profile, such as vegetable oils, nuts, and fatty fish; and any combination of these foods so long as they do not contain ingredients that contain saturated fat, sugars, and sodium.
  2. Foods that provide a source of nutrients that are not commonly accessible in other foods and that most Canadians do not receive enough of, such as cheese and yogurt, which include calcium and are manufactured from dairy products. These are examples of foods that fall into this category.
  3. Foods that are developed specifically to fulfill the requirements of a particular demographic, such as rations for usage by members of the armed forces.

Standard Format Details

Changes are introduced for the following standard formats

  • Language
  • Location
  • Orientation
  • Visibility
  • Order
  • Type
  • Leading
  • Rules
  • Indents
  • Colour in the Nutrition Facts Table
  • Crowding of Information and Narrowing the Nutrition Facts Table
  • Adjusting the Nutrition Facts Table Rectangle
  • Dividing the Nutrition Facts Table
  • Destruction of the Nutrition Facts Table Upon Opening of the Package
  • Abbreviations and Symbols in the Nutrition Facts Table
  • Presentation of Certain Additional Information in the NFT
  • Tailoring of the Linear format and Language Specifications

Abbreviations and Symbols in the Nutrition Facts Table

Consultations with members of the public back up the idea that readers often have trouble understanding what is meant when abbreviations are used. The following are the only acronyms that can be used in the Nutrition Facts table (NFT) because of this restriction on the number of allowed abbreviations:

  • “% Daily Value” or “% DV” for “Percent Daily Value” (English expression)
  • “% valeur quotidienne” or “% VQ” “pourcentage de la valeur quotidienne” (French expression)
  • “Vit” for vitamin
  • “kJ” for kilojoules

The shortened forms “% DV” or “% VQ” should be limited to the particular NFt figures they are authorized, as stated in the Directory of Nutrition Facts Table Formats. This will ensure that the information presented is accurate.

When the abbreviated form “% DV” and “% VQ” subheading is used within the NFt rather than the long form “% Daily Value” and “% valeur quotidienne,” the asterisk (*) that follows it also links the abbreviation to an explanation of its meaning, elsewhere within the table (i.e., * DV = Daily Value; * VQ = valeur quotidienne), as demonstrated in the example that follows.

Conclusion

The Canadian government has changed the information available on food and nutrition items. The information on the list of ingredients seen on food labels has been improved due to input from consumers and stakeholders.

Now customers will have more access to more information and can decide what is better for them and their children.

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in Health Canada Food & Beverage Compliance.

We can assist you with your food label and packaging compliance/translation, Nutrition Facts Table creation, TMA License, Novel Food Notification, SFCR License, HACCP, or PCP setup.

We also offer GRAS Notification and Supplement Food Compliance Solutions.

Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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Blog

FDA NAC Warning Letter: Targeting N-Acetyl Cysteine (NAC) Supplements

Background on FDA NAC Warning Letters:

Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key to ensuring compliance, avoiding costly penalties and maintaining a successful business relationship with federal regulators. This guide will teach you how to understand FDA warning letters and provide guidance on how to comply.

N-acetyl-L-cysteine (NAC supplement) has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease, according to a summary of the study sponsored by the Memorial Sloan Kettering Cancer Center in New York. NAC is an amino acid that was approved by the FDA as a drug in 1963. 

NAC has also been widely marketed in another category of products overseen by the FDA—dietary supplements. However, there have been several instances where the FDA has challenged the legality of NAC use in dietary supplements.

What is the FDA’s NAC System?

The FDA’s NAC system is a regulatory program that provides for the assessment of risk and imposition of requirements, restrictions and prohibitions on foods, conforming to safety standards. It includes warning letters issued by the FDA to food companies that fail to comply with the Food Safety Modernization Act (FSMA). Warning letters provide guidance on steps necessary to bring the company into compliance.

FDA NAC Warning Letters

In 2010, the FDA issued a warning letter indicating that it believed that NAC was a drug and as such is not allowed to be used as an ingredient in dietary supplements. However, the FDA has still received several dietary supplement claims notifications including NAC as an ingredient tied to a structure/function claim. Up until recently, NAC had been successfully marketed as a dietary supplement product with no enforcement action.

As of recently, the FDA has issued warning letters to companies marketing dietary supplements indicated for the treatment of hangovers, as the ingredient NAC is excluded from the definition of a dietary supplement (since it was already categorized as a drug in 1963). Dietary Supplement products containing NAC are considered an unapproved drug product, and therefore illegal.

How to Identify Common Errors Before a Warning Letter is Issued?

Before you receive an FDA warning letter, it’s important to make sure your processes are compliant with FSMA requirements. By identifying common errors and taking corrective actions early on, food companies can avoid significant delays or actions resulting from a warning letter. Reviewing existing systems and practices for compliance is the first step to preventing warnings letters. Make sure all of your documentation is up-to-date and accurate, while also being able to demonstrate that all FSMA requirements are consistently met.

Understanding Your Options Once A Warning Letter Is Received:

Once a warning letter is issued, the FDA will provide guidance on how to resolve the matter. Depending on the severity of the violation or the regulations broken, companies may have different options for remediation. These could include product recalls, facility closure plans, repackaging of products, and revising standard operating procedures. Companies should also investigate certain areas such as employee training and record keeping if an observation is related to human error. This process should be well-documented throughout in order to demonstrate that FSMA regulations have been met and corrective actions have been taken.

Creating An Effective Response To An FDA Warning Letter:

As soon as an FDA Warning Letter arrives, it needs to be addressed immediately. A comprehensive response should be sent within the prescribed timeline and include corrective actions taken or planned, along with any evidence of success or additional steps necessary to complete them. Companies should also demonstrate how current systems are in compliance with the applicable regulations and specify what measures will be implemented to ensure they remain compliant. This response must come from the appropriate personnel and be signed by a competent official, such as a Chief Compliance Officer (CCO).

Best Practices For Ongoing Compliance With The NAC System:

It’s important to create and maintain a comprehensive FDA compliance management system that can actively monitor for deficiencies that lead to issued warning letters. A CCO-driven corrective action plan should be implemented and monitored, with personnel trained on proper procedures at all levels of the organization. Procedures should also be in place for reporting any noncompliance issues quickly and accurately. Regular reviews of SOPs, GPs, document controls, quality system training, internal audit findings and policies should also take place to ensure ongoing FDA compliance.

Response from Retailers

Amazon has recently been quietly removing dietary supplement products containing NAC from their site, shortly after the news of the FDA’s warning letters. There has also been a push by Amazon and other retailers such as Walgreens to ensure products that are being sold through their channels are compliant.

How can we help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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News

Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023

The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments.

The fiscal year will begin on October 1st, 2022, and end on September 30th, 2023. All medical device facilities will have to pay these fees to remain FDA-compliant.

In this blog, we’re going to elaborate on everything that you should know going into 2023 and which we’ll elaborate on everything you should know including which fees may apply in 2023.

FDA Medical Device MDUFA Fees in 2023

Medical Devices and Establishments:

  • Certain medical device applications 
  • Periodic reporting on class III devices 
  • Annual registration of establishments 

All businesses that have sales that are less than $100 million in the most recent tax year can qualify as small businesses and pay a reduced fee on their applications.  If your business has sales of less than $30 million you can receive a waiver for your first premarket application or reports.

These Medical Device Establishment registration fees are consistent no matter the business size and must be paid to complete registrations.  There are no waivers or reductions for small businesses, establishments, or groups when it comes to this establishment registration fee.  This fee must be paid for every physical location a company owns that handles applicable medical device functions.  All medical device fees have increased to deal with inflation over the last year as a result of FDA suggestions.

What is the purpose of Medical Device User Fees:

  • User fees are used to fund FDA’s medical device regulatory programs
  • MDUFA fees are used to fund the medical device user fee program
  • FDA uses these fees to review new medical devices and monitor the safety of existing devices
  • FDA has a budget for these fees

FDA’s Medical Device User Fee Programs:

  • MDUFA VI is the sixth amendment to the Medical Device User Fee and Modernization Act (MDUFMA)
  • MDUFA VI was signed into law in December 2017
  • MDUFA VI will go into effect on October 1, 2022

FDA’s Proposed FY 2023 Medical Device User Fee Rates:

  • increase in fees for the first time since 2017
  • MDUFA VI rates are based on the number of submissions and inspections
  • MDUFA VI rates are based on inflation and volume
  • MDUFA VI rates are lower than the proposed FY 2023 MDUFA VI rates

FY 2023 MDUFMA Financial Highlights:

  • FDA is proposing to refund 50% of the user fee for 510(k) applications filed in 2023
  • FDA is proposing to refund 50% of the user fee for Premarket Reports filed in 2023

FDA’s Proposed FY 2023 Refund Policy for the Premarket Application User Fee and the Premarket Report User Fee:

  • FDA is proposing to refund 50% of the user fee for 510(k) applications filed in 2023
  • FDA is proposing to refund 50% of the user fee for Premarket Reports filed in 2023

How Quality Smart Solutions can help

FDA won’t consider medical device registrations to be complete until all required payments have been paid and the deadline for renewal is December 31st, 2022.  If not paid, the FDA can remove your registration from its database.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device licenses and registrations.  We can help you by responding to potential information requests, keeping your licenses and registrations updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! For more assistance with FDA regulatory requirements call 1-800-396-5144, email: info@qualitysmartsolutions.com, or book a FREE regulatory consultation with one of our experts using the form.

How Quality Smart Solutions can help

How can Quality Smart Solutions help you ensure your 510k medical devices are FDA-compliant? We offer medical device license application services that consist of preparing and submitting applications, as well as handling communication with the FDA. Our team of experts can handle all medical licensing matters and are happy to help you with future projects or questions! Please find our contact information here:

Contact our Compliance Experts to Discuss Your Needs.

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