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MDSAP: What Is It and How Does It Apply to my Medical Device?

Who Needs an MDSAP Certificate?

Anyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These certificates are evidence that your company has an appropriate quality management system in place to ensure that only safe and effective medical devices are made available for sale.

How do I obtain an MDSAP certificate?

First you must implement a quality management system within your company that meets the requirements of ISO 13485. The areas covered by these practices include design and development, production, storage and distribution, installation, and servicing of medical devices. Once all applicable procedures are in place you must contact an auditor that has been authorized to issue MDSAP certificates. Only certificates issued by approved auditors will be recognized by Health Canada.

Note that these certificates include a scope of the types of products that your company is authorized to manufacture. For example, if you obtain an MDSAP certificate for the manufacture of medical gloves you can get an MDL for medical gloves but not for home pregnancy tests. The scope of the certificate must match the type of product being sold. If you need to expand the scope of your certificate you must contact your auditor.

Why is it called a single audit program?

Historically every country would require their own audit of medical device manufacturer’s quality management system. This led to a situation where a company looking to sell in 5 different countries would often require 5 different audits of the quality management system. In order to reduce the burdens associated with multiple audits, several countries banded together to form the Medical Device Single Audit Program. Certificates issued through MDSAP will satisfy the audit requirements for all participating countries.

Countries that currently recognize MDSAP certificates include:

  • Australia
  • Brazil
  • Canada
  • Japan
  • USA

Are there any exemptions? What if I have an ISO 13485 certificate but it’s not MDSAP?

Health Canada won’t accept any other ISO 13485 certificate even if it’s from a major market such as the European Union. The only exception that has ever been granted is for devices related to the COVID-19 pandemic. Health Canada created a special approval pathway for these devices that would allow non-MDSAP certified companies to obtain authorization to sell their products.

I don’t have an MDSAP certificate and I’m not interested in obtaining one. What are my options?

The only option in this case is to enter into a private label agreement with a company that has one. The company you partner with must already have an MDSAP certificate and an MDL for the product they will be making. You will need to submit a Private Label Licence Application to Health Canada that states that your business partner will be conducting all manufacturing work and the product is identical to the already licenced product in every way except brand name and the company name listed on the label.

How Quality Smart Solutions can help:

Quality Smart Solutions offers many avenues of support including full support for obtaining any Medical Device License. Our team is equipped with professionals who have extensive experience in the Canna, Pharmaceutical, Natural Health Product, Food and Medical Device industries.

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GRAS or NDI? Factors to Consider

Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is considered approved (and the product will not be considered adulterated upon formulation) for use, you have a decision to make: Do you wish to obtain ingredient approval through GRAS (Generally Recognized As Safe) or via NDI (New Dietary Ingredient)?

This blog will explore the concepts and requirements surrounding both GRAS and NDI to help you navigate your ingredients into the US food supply. We will discuss each pathway and reasons why your company may want to favour one over the other.

What Does GRAS stand for?

GRAS stands for “Generally Recognized As Safe”. GRAS is the more flexible option as these decisions allow use in foods and dietary supplements no additional processing is applied to the ingredient. 

How Do I Classify my Ingredient as GRAS?

Ingredients can be self-affirmed GRAS or submitted via notification to the FDA for approval

Self-AffirmedThe ingredient must be widely used in the food supply to meet the self-affirmed criteria. GRAS assessments require the substantiation/evidence to be made available to the public upon approval, thus limiting discretion. The requirement for proof is use in conventional foods for a long period of time and/or the food is considered safe by experts. Essentially you need to prove safe historical use. 

Notification to the FDA – FDA reserves the right to take 180 days or longer to evaluate a GRAS notification. Once an ingredient is approved via the GRAS route, it can be used in both food and dietary supplements. GRAS ingredients must meet the safety standard: reasonable certainty of no harm under the intended use conditions. GRAS ingredients must meet the lower GMP standards set out in 21 CFR 110. To summarize, this notification process takes longer to obtain, but allows for use of the ingredient in food and dietary supplements.

What Does NDI Stand For?

NDI stands for “New Dietary Ingredient”. Unless considered an ‘old dietary ingredient’ (used in dietary supplement products prior to October 15, 1994), an NDIN (New Dietary Ingredient Notification) must be sent to and approved by the FDA. NDI approved ingredients are only approved for use within Dietary Supplements, thus limiting applications and uses of your ingredient. 

The NDI notification process will keep your submitted documentation largely between you and the regulator and is a good option for proprietary research/documentation. The NDI review standard is within 75 days, a considerably shorter timeline. NDI ingredients must meet the safety standard: does not present a significant or unreasonable risk of illness or injury. NDI ingredients must meet the higher GMP standards set out in 21 CFR 111. To summarize, this notification process is shorter in overall length, but only allows your ingredient to be used in dietary supplements. 

Summary

In conclusion, although the GRAS notification process takes longer on average it allows the most flexibility for end use (ie. use in dietary supplements and in food). NDI allows you to keep your documentation private, has a shorter review period but only allows you to market your ingredient within Dietary Supplements. There are pros and cons to each. Ultimately, how you wish to position your finished goods is the best deciding factor to choose GRAS or NDIN. The self-affirmed pathway allows for the quickest pathway to market, but you are still required to have significant evidence/proof. 

How Quality Smart Solutions can help:

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labelling projects. Our specialists are here to help!

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Consultation Period Extension: Proposal to Improve Natural Health Product Labelling

On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada held extensive pre-consultation with a wide array of stakeholders in the development of the policy and prior to publication in Canada Gazette, Part I. The Canada Gazette, Part I consultation period process allows all stakeholders to review the proposed regulations and comment on the analysis of the potential positive and negative effects of a proposal on the health, safety, security, the social and economic well-being of Canadians, businesses and on the environment.

Recognizing that the timing of this consultation coincides with the summer holiday period and that there are a number of consultations underway at Health Canada, which may also be of interest to industry, the Canada Gazette, Part I public comment period is extended to 90 days and will now close on September 24, 2021. The details of how you can provide your feedback on the proposed amendments to the Natural Health Products Regulations can be accessed on Consulting with Canadians web page.

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Proposal to Improve Natural Health Product Labelling

Natural Health Product Labelling

On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations. The proposed changes would directly affect natural health product (NHP) labelling requirements.

What are Natural Health Products?

As defined by Health Canada, natural health products are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms, and marine sources.

A wide variety of NHP’s, such as vitamins, probiotics, and minerals, are used daily by many Canadians. The COVID-19 pandemic has increased the demand for these products, as consumers are becoming progressively self aware and are wanting to take more control of their own health.

Why Are Changes Being Proposed?

Health Canada is conscious of the growing usage of NHP’s among Canadians and is therefore trying to improve the understanding of NHP’s by proposing an amendment that will enhance plain language labelling. The goal of the amendment is to improve representation of key information on product labels to help consumers make more informed decisions.

The importance of labelling can be demonstrated by an online poll that was published by the Office of the Auditor General. The poll asked participants to rate different factors that influence the purchasing of NHP’s. The results of the poll identified that a product label was the second most important factor that influences consumer decisions, among other strong factors that were rated less significant, such as recommendations from family, and pricing.

What Are the Proposed Amendments?

The proposal by Health Canada includes four key elements that can be summarized below:

  1. A Product Facts Table:Includes important product information, such as warnings and directions for use, that would be presented in a standardized table.
  2. Clearly and prominently displayed label text:Rules would be introduced to improve NHP label legibility and readability (ie. minimum font size requirements).
  3. Labelling of food allergens, gluten, and aspartame:Priority food allergens, gluten and aspartame would be identified in the warning section of the label.
  4. Modernized contact information:A manufacturer may display either an e-mail address, telephone number or website instead of a postal address, as currently required.
 

If the proposal were to be registered as part of the Natural Health Products Regulations, there would be a transitional period of 3 years to allow NPN license holders to make the appropriate changes to product labels.

How to Participate in the Consultation

The public consultation for the proposal to improve natural health product labelling opened on June 26, 2021 and will close on September 4, 2021. Health Canada welcomes comments and feedback on the regulatory proposal from all interested parties.

Sources:

www.canada.ca, www.oag-bvg.gc.ca

How We Can Help

Quality Smart Solutions offers a Canadian natural health product label compliance service. This service includes a complete review of your NHP label to determine if all regulatory requirements are implemented. The label compliance service utilizes a collaborative approach between the experts and our clients to ensure a compliant label is produced for the Canadian market.

Our team of experts at Quality Smart Solutions are continuously staying educated on the evolving NHP labelling requirements. Please contact us to learn more about NHP labelling or about how we can help with your NHP label!

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Benefits of Using a Third-Party Auditor for Your Canna Facility

In the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or regulatory framework requirements. While audits have received negative stigma and are commonly dreaded, if performed properly and regularly, audits are useful tools to make sure that compliance is consistently and effectively implemented throughout all canna operations.

There are three main categories of audits depending on the relationship between the auditor and the auditee. First party audits, also known as internal audits, are performed by the company’s QA department. Second party audits are external audits performed on a supplier by a customer. Third-party audits involve an independent auditing company to assess whether the company is successful in meeting prescribed standards.

Canna facilities can greatly benefit from third party audits. Here are three reasons why.

  1. Allows a fresh pair of eyes and provides objectivity

    As two heads are better than one, two sets of eyes are more effective when reviewing and evaluating company compliance. Since internal QA staff ‘live and breathe’ the program everyday, it is helpful for an external party to verify the program. Third party auditors are able to come in and provide a completely neutral assessment and review of a company’s systems and processes without the natural familiarity that occurs over time with regular staff and day-to-day routines. The objectivity of a third-party audit provides a more accurate review of what is occurring within the company.

  2. Supports internal QA Department

    Audits conducted internally can be taxing on time and labor resources and take away from overall business function. A third-party auditor is able to enter a location for the sole purpose of conducting an audit and perform the audit and interviews in a timely and efficient manner without interrupting the efficiency of the company. The third-party auditor also reduces the pressure on internal QA resources when delivering s to senior management and colleagues that are not that favorable.

  3. Creates a more robust Program

    It is important to know which framework the audit will be performed, as this provides the context on the areas and processes that need to be verified. A federally licensed canna facility must be compliant with Good Production Practices (GPP), physical security requirements and other requirements defined in Health Canada’s Canna Regulations. Canna facilities that intend to export into Europe must also comply with EU GMP standards within the Eudralex framework.

    Experienced third party auditors in these standards and framework have the benefit of having conducted audits in multiple environments and are able to share best practices that can strengthen individual programs. Industry-wide knowledge held by third party providers can serve to validate existing programs and provide recommendations for growth or change when deemed necessary.

A well prepared and well executed audit can make a substantial difference in improving operations and maintaining compliance. Thoroughly completed audits with proper follow through are viewed favorably by regulatory agencies and can strengthen a company’s Quality Management System.

How We Can Help

QSS can provide third party auditing services and verify compliance in standards and frameworks required in canna facilities.

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Consultation on Proposed Feeds Regulations

On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize the Feeds Regulations, 1983. The consultation to obtain feedback from the public will close on September 10, 2021. The pre-published proposed regulations are currently posted in the Canada Gazette, Part I for individuals to read through prior to participating in the consultation.

What are the Feeds Regulations?

The Feeds Regulations, 1983, set out requirements for the importation, manufacture, and sale of feed (including feed ingredients) in Canada. Feed is defined as “animal food” which is also regulated by the Health of Animals Regulations. These regulations also regulate the use of rendered animal protein products (e.g. animal meat and bone meal, feather meal, tallow, poultry fat) for use in ruminant and other animal feed.

The CFIA verifies that livestock feed manufactured, sold or imported in Canada are:

  • safe for animal health and the environment
  • effective for animal production
  • comply with standards
  • are labelled appropriately 
  • are safe for livestock that would be used for human consumption (meat, milk, eggs)

What is the objective of this modernization process?

The amendments that are being proposed to the Feeds Regulations, 1983 are required to ensure that a more robust regulatory framework is placed. This would include things such as hazard identification, preventive controls, traceability, increased record-keeping requirements and licensing requirements. 

These measures would allow the CFIA to better understand and manage risks that livestock feeds pose to human, animal and plant health and the environment. In addition, they would allow the proposed Regulations to align with international frameworks and best practices.

What are some of the key changes being proposed?

The proposed Regulations would apply to feed ingredient and mixed feed manufacturers, feed retailers and distributors, feed importers and exporters, as well as on-farm feed manufacturers that sell off the farm or incorporate any drug or other substance that presents a risk of harm to human or animal health or the environment into their feeds. The scope of the framework would apply to the domestic supply chain as well as to feeds being imported and exported.

Scope of species — Definition of livestock

The additional species to which the Feeds Act and the proposed Regulations would apply are game birds, ratites, bison, water buffalo, cervids, llamas, alpacas, molluscs, crustaceans and bees. Mink and fox would be removed, as they are not considered food producing animals.

Incorporation by reference

The amendments would incorporate by reference nine documents, written, maintained and published by the CFIA:

  • Canadian Feed Ingredients Table;
  • Compendium of Medicating Ingredient Brochures;
  • Compendium of Non-Feed Product Brochures;
  • Tables of Nutrient Guarantees and Conditions for Feed Labels;
  • Tables of Permissible Claims for Feed Labels;
  • List of Weed Seeds and Maximum Levels for Feeds;
  • Tables of Maximum Nutrient Values for Feeds;
  • Tables of Maximum Contaminant Levels for Feeds; 
  • List of Prescribed Deleterious Substances.

Permissions (approvals, registrations and licences)

An updated, clearer and broader permissions approach for feed products (approvals and registrations) and individuals (licensing) would be established in the proposed Regulations. This includes:

  1. Feed ingredient approval
  2. Feed registration
  3. Licensing of individuals

General and safety standards for feeds

General and safety standards for feed would be updated to better reflect current science, risks, production practices and technology. 

Labelling

Labelling requirements would be updated to reduce prescriptiveness and rigidity, provide better information to purchasers, with health and safety labelling requirements to appear in both official languages. Improved flexibility would be provided by allowing additional information, such as claims and guarantees, to be added to the label without requiring the feed to be registered. To increase the traceability of feeds through the supply chain (in the event recalls are necessary), feeds would need to be labelled with a lot number/identification code. 

Mandatory bilingual labelling requirements would be required for any label information that could impact the health and safety of the purchaser or livestock to be fed with the feed product. This would include medication information, and caution and warning statements.

Feed hazard identification and preventive controls

Under the proposed Regulations, regulated parties would be required to conduct a hazard identification (e.g. biological, chemical and physical hazards) for the feeds they manufacture. In addition, they would be required to develop, implement, and maintain a written preventive control plan to demonstrate how the preventive controls (e.g. cleaning and sanitation, pest control, conveyances, equipment, contaminated material, interior of the facility, movement of persons, and water, steam and ice) and other requirements (e.g. packaging and labelling) are met. 

Traceability

New traceability requirements would require more detailed record-keeping requirements to better support risk management along the feed supply chain, especially where timely responses to incidents of risks to public, animal or plant health or the environment are involved.

How do I participate in the consultation?

The first step would be to read the proposed regulations in Canada Gazette Part I. Once you have an understanding of the changes being proposed, submit your comments using the online regulatory consultation system.  You can also read the fact sheets and guidance documents to better understand the proposed regulations and join a webinar to learn more!

How We Can Help

Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance for NHPs registration and importation.

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Animal Supplements in the USA

Animal Supplements in the USA – What You Need to Know

How are animal supplements regulated in the USA?

Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The U.S. Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) confirms that the DHSEA does not apply to animal products. Therefore, animal supplements are not regulated as dietary supplements in the USA, but rather as food, or drugs, depending on the intended use. 

What are Animal Supplements/Feed?

Animal (pet) food or feed products are regulated by the CVM and they are defined as “animal food ingredient, to become part of an ingredient or food, or added to an animal’s drinking water”. The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets requirements in sections 402 and 403 on food and products may be deemed adulterated or misbranded if requirements are not satisfied. For example, false information on food labels, unsanitary food packaging, and animal feed containing poisonous substances. 

The FD&C Act states that any substance added or going to be part of the animal food, directly or indirectly, must follow food additive regulation or be Generally Recognized as Safe (GRAS) for that intended use. Examples of GRAS animal feed ingredients are forages, grains, and most of the vitamins and minerals. Other substances that do not appear in final animal food products but to give flavour or texture may also be considered food additives. The approved food additive list for animal feed can be found in 21 CFR 573 and partial GRAS list for animal feed can be found in 21 CFR 582 and 584. 

What Claims Can I Make For My Product?

The FD&C Act states that if the product contains structure function claims or its intended use is to cure, treat, prevent, or mitigate disease, the product is considered a new animal drug. All new animal drugs require approval through New Animal Drug Application by providing evidence on its safety and efficacy for its intended use. Food labels can have statements on the label regarding the product’s nutrition, aroma, or taste. The CVM publishes policy and permits some health information on the animal food label such as urinary tract health and dental health. These claims require approval by CVM before they can go on the label. All claims need to be truthful and accurate in the indicated species.

How Does the FDA Enforce Animal Supplements?

The FDA will flag “animal supplement” products that are being marketed as foods, but make egregious claims, for example, intending to treat a disease. Other examples include shelf-life evaluation, mislabelling, and containing unapproved substances or additives (e.g. CBD). The FDA may issue warning letters to businesses making these claims without proper substantiation. If this is the case, work closely with the FDA and see what changes are required to the product.

How We Can Help

QSS offers regulatory services for your animal food or drug products to make sure they are in compliance with the applicable regulations. Contact us today to learn more!

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