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What You Need to Know – Software as a Medical Device (SaMD)

The advancement of technology is rapidly  progressing, and the evolution can be observed all around us. As cutting-edge technology becomes more available, there appears to be a shift with regard to how work is carried out across several industries. Within the last decade, the healthcare field has seen an increased amount of software being utilized in medical devices. Software has become an important aspect of medical devices and is proving to benefit both patient and provider. 

What is Software as a Medical Device (SaMD)

There are various types of medical device software, but an emerging software of interest is known as Software as a Medical Device’ or SaMD. As defined by several regulatory bodies, SaMD “is software intended to be used for one or more medical purposes and it performs these purposes without being part of a hardware medical device.” In other words, SaMD is a type of software that works independently from another device. 

For example, a mobile application that takes input from a blood glucose meter to provide insulin dosage recommendations for diabetes is considered SaMD. But the software used to take the blood glucose meter reading is not considered SaMD, as this is software that supports the medical device and therefore can not function without it. Other examples include software that analyzes physiological signals that are collected from sleeping, software that uses digital mammograms to calculate breast density percentages and even software that permits smartphones to view images captured from a computerized tomography (CT) scan. 

Advantages of Using (SaMD) in Healthcare 

SaMD offers numerous opportunities and has the potential to refine integral systems in a healthcare setting. This is due to the possibility of automating certain aspects that can lead to better treatment for patients. SaMD’s main advantages include improving healthcare outcomes and faster response times. 

There are several intended uses for SaMD that can benefit both the patient and the provider, 

  • Treat or diagnose– information provided by SaMD can be used to accurately detect a disease or condition and help reduce the time from diagnosis to treatment.
  • Drive clinical/patient management– SaMD can help better identify early warning signs and provide real time recommendations. Also, can aid clinicians with making a definitive diagnosis, by analyzing relevant information.
  • Inform clinical/patient management- SaMD allows clinicians to better advise their patients regarding options for personalised treatment plans. 

Compliance Measures 

The FDA and Health Canada have similar SaMD classification guidelines based on risk categorization. The class and/or category of SaMD is determined by the state of the healthcare situation and the significance of information provided by SaMD to make a healthcare decision. Other factors of consideration include the degree of invasiveness in the body, duration of contact and local versus systemic effects. Both regulatory bodies have stated that as the medical device software field evolves, policy reform will follow to prioritize patient safety and clinical effectiveness. 

Aligned Interests 

Are you a company operating in the medical device software space and need help navigating the complex classification system or want to enter the medical device software market? Our team of knowledgeable subject matter experts can provide the necessary regulatory support with respect to preparing and submitting SaMD applications. Contact us today or call us at 1-800-396-5144!

References

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html  

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html  

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html  

www.selecthub.com/medical-software/software-medical-device-samd/

www.torys.com/insights/publications/2018/11/software-as-medical-devices-and-digital-health-in-canada.

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How to Risk Detention of CPG at the border

How to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods

As an importer of consumer packaged goods, unanticipated delays at the border will cost time and money and can greatly impact your business. The Canadian Border Services Agency (CBSA) has the authority to detain consumer packaged goods at the border which prevents the entry of the shipment into Canada. These delays can cause unnecessary frustration, lead to a supply chain nightmare, and can impact operations significantly. However, detained shipments are avoidable. 

The most common reason for shipment hold-ups at the border pertains to documentation. Completeness and accuracy of paperwork is crucial. More importantly, it is important to understand what information CBSA requires when completing the forms. Here are some things that are frequently overlooked or misunderstood and can possibly result to importing delays.

Missing Paper Work

Examples of situations that will result to importing delays at the border – The freight company only has a Bill of Lading and is not given any other documents such as a commercial invoice or Canada Customs invoice. The document is not the correct document to obtain a Customs clearance (i.e. purchase order or pick ticket).

There are four main documents needed for importing into Canada: (a) Canada Customs Invoice, or a Commercial Invoice; (b) Bill of Lading; (c) Manifest or Cargo Control Document; and, (d) Shipper’s Import/Export Declaration. Depending on the CPG to be imported, additional licenses or permits may be required. 

Check for any special requirements or extra documentation that may need to be taken to properly clear the goods across the border prior to ordering or shipping. A licensed Customs Broker would be able to properly advise on what is needed in order for your shipment(s) have a seamless Customs clearance process.

Insufficient Information 

Documents are improperly completed and do not have sufficient information to prepare the entry for presentation and clearance with the CBSA. Information that can cause hold ups include:

  • business number
  • goods description
  • tariff classification
  • commodity value
  • country of manufacture or origin
  • total number of pieces; and,
  • weight.

Unclear Import of Record

Documents are hard to decipher who is the actual Importer of Record (IOR). The IOR can be the consignee or the receiver of the goods, the shipper, or an authorized third party. Importers and/or their authorized agents are responsible for the calculation and declaration of the value for duty of imported goods in accordance with the valuation provisions of the Customs Act.

Customs broker not identified

Engaging a customs broker is not mandatory but it is helpful when importing CPG. In the case that there is no customs broker, this should be clearly identified  on the documents so that CBSA understands that you are preparing your own release and accounting documentation and transacting business directly with the CBSA. 

The release of the shipment will require:

  • Paying any duties that may apply;
  • Obtaining, preparing and presenting or transmitting the necessary documents or data;
  • Maintaining records; and
  • Responding to any CBSA concerns after payment.

The benefit of having a customs breaker is that they will do all activities to obtain the release of the imported goods. The CBSA has a list of licensed customs broker within Canada which identifies locations each broker is licensed.

The Commodity Itself

A delayed shipment can also be due to the actual commodity being shipped. Before proceeding with importing, ensure the goods to  be imported are permitted into Canada or whether the goods are subject to any permits, restrictions or regulation. For more information on prohibited products, Memoranda Series D9 provides more information on prohibited importations.

Some goods have Participating Government Agencies (PGA) involved in approving the goods for Customs clearance, such as items that are under control of Canadian Food Inspections Agency (CFIA). They require CFIA approval and some commodities are under quota and require an Import Permit. Certain goods are subject special import measures while some are covered by specific domestic controls.

Understanding the CPG being imported and the required paperwork are two main things that can reduce the risk of your shipment delays at the border.

How can we help

Our mission is to see your business thrive through compliance and risk mitigation. With a team of former FDA AND Health Canada regulatory agency officials, regulatory experts, quality assurance specialists and industry professionals, we provide insights and strategies to navigate the complex journey of regulations to help you make clear, decisive decisions to grow your business. 

Our sister company, Quality IMPORT Solutions, holds a Health Canada license to import Natural Health Products and a CFIA license to import conventional and supplemented foods.

30 Minutes Free Consultation
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Benefits of Routine Inspection of your Licensed Food Facility

Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review of the processes and procedures will lead to higher quality products that are safe for Canadians. Internal/self-inspection is important in day-to-day operation to ensure all processes are flowing smoothly, however third-party inspections are important to get a fresh set of eyes and to obtain relevant accreditation. 

Why are inspections conducted?

CFIA and/or Health Canada inspections are important to ensure all processes are in alignment with the regulations (such as the Safe Food for Canadian Regulations). The goal is always turning out safe and high-quality products for Canadians to purchase and enjoy.

What processes are checked during an inspection?

Common activities for foods are manufacturing, processing, treating, preserving, grading, packaging, labelling. CFIA will inspect your site based on the risk involved with the products you produce and the activities you undertake. For example: if you slaughter animals, you will likely have more frequent inspections. 

What are the benefits of routine inspection?

Identifying risks and the hazards that may arise is crucial to food manufacturing. Audits are a great tool to identify and reduce these risks. Self-inspection should be built into your SOPs to ensure staff members internally self-reflect on their assigned tasks. Third-party inspections allow a fresh set of unbiased eyes to review your practices and policies. All three are very important to your business. 

Some of the many benefits of Inspection are:

  • Inspections help identify health risks for your consumers and employees. Pointing out process errors may be able to correct a future safety issue. A health risk or recall may be detrimental to your business’ public perception and marketability. Avoiding issues that may arise from a quality violation is reason enough to schedule an inspection. 
  • Inspections are a great learning tool. Any items noticed during the inspection will lead to facility and staff improvement. Constant and ongoing improvement is key to product quality and to your business. Any time there is room for learning opportunities, it can provide growth and skill development for your company. 
  • Inspections can keep your business open. High risk deviations that are found may lead to facility closure until the issue can be corrected. Minimizing these issues will mitigate potential reasons for closures. Preventing these types of issues of any size will reduce financial obligation to correct the issue, if it were to become a larger problem. 
  • Passing an important inspection is a great accomplishment! Practicing for governmental audits and inspections with an in-house or with a third-party review can help prepare your site and staff to ace an inspection in the future. Accreditation that results from some audits will help grow consumer trust and can even be advertised in some cases. 
  • Improving the preparedness and cleanliness of your site. Sometimes even preparing for an audit is reason enough to do a more thorough tidy of the facility. Impressing an inspector is important to a successful review. This is a clear reason to schedule an audit. 

Summary

Running through and reviewing the quality processes and documentation for your site will always lead to company improvement. Being able to identify issues and correct them is a main pillar of food safety and quality. Inspections offer a thorough look into the operations of your company.

If you have any questions regarding food facilities, licensing/registration, and inspections/audits, please reach out to one of our specialists! We are always happy to help!

Resources:

  1. https://inspection.canada.ca/food-licences/food-business-activities/eng/1524074697160/1524074697425
  2. https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html
  3. https://inspection.canada.ca/food-licences/licensing/eng/1523903020086/1523903065567
  4. https://www.health.gov.on.ca/en/pro/programs/publichealth/enviro/docs/training_manual.pdf
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How to sell Hemp Oil Health Products in Canada?

What is Hemp Seed Oil categorized as in Canada?

In Canada, Hemp (Canna Sativa) seed oil can be categorized as a Natural Health Product (NHP), which means it is regulated by Health Canada under the Natural Health Products Regulations. Under the regulations, NHPs are defined as products containing naturally occurring substances including probiotics, herbal remedies, vitamins and minerals, homeopathic medicines, traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risk, and maintain general good health. Hemp seed oil is currently listed under the “Multiple Ingredient Fixed Oil Products – Oral Product Monograph” with Health Canada.

Natural Health Products Ingredients Database

The Natural Health Products Ingredients Database (NHPID) is a database that Health Canada built to store pre-cleared information approved by the Natural and Non-prescription Health Products Directorate (NNHPD). 

According to the NHPID, to use hemp seed oil as a medicinal ingredient, in a natural health product, this ingredient “must not contain more than 10 parts per million delta-9-Tetrahydrocannabinol (THC), or phytocannabinoids that have been isolated or concentrated. The determination of the THC concentration must take into account the potential to convert delta-9-tetrahydrocannabinolic acid (THCA) to THC.” 

The finished product containing hemp seed oil must have a tolerance requirement of <10 ppm for THC, and zero or not detected for cannabidiol (CBD). The database also indicates that “Hemp derivatives must also be compliant with the Industrial Hemp Regulations (IHR). All sources of hemp falling under the IHR are expected to be of an approved cultivar, defined in the IHR as any variety of industrial hemp set out in the List of Approved Cultivars, published by the Government of Canada on its website, as amended from time to time.” 

This list of approved cultivars for 2021 growing season can be found in here

Natural Product Number

Like other NHPs, products containing hemp seed oil must have a product license and the Canadian site must have a site license to conduct activities including manufacturing, packaging, labeling, and/or importing in Canada. Prior to selling the product, the company must submit an Natural Product Number (NPN) application for Health Canada to review and assess the product’s safety, efficacy, and quality. Once it has been approved, Health Canada will issue the product a product license and give permission for the company to sell the NHP in Canada. This product license comes with an eight-digit Natural Product Number (NPN), and this number is required to be present on the front panel of the NHP label.

NHP Label

All NHPs must have a bilingual NHP label that is compliant with the NHP Regulations. This is to ensure the NHP is labeled and packaged according to regulations to help consumers make more informed choices about the NHP they take. There is a list of specific requirements and information that must appear on the NHP labels, both inner and outer, and the information is based on the product license received from Health Canada, including dosage form, recommended purpose, risk information, medicinal ingredients, non-medicinal ingredients, and product license holder information.

How can we help

QSS offers North American regulatory services for submitting applications for your NHPs, preparing French translations, reviewing your NHP labels. Our experts are here to help and offer any NHP-related regulatory advice!

30 Minutes Free Consultation
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US Establishment Registration Renewals

It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually between October 1st and December 31st. Even facilities that registered as late as September 30th, 2021 are still required to renew their registration. 

Facilities located outside of the U.S. must also designate a U.S. Agent to communicate with the FDA on their behalf. The FDA will not finalize a facility’s renewal until the U.S. Agent accepts the designation. Failure to renew a facility registration during the renewal period could result in the cancellation of the registration.

Drug Facilities

When an establishment registration renewal is filed with the FDA, the facility identifier will remain the same after the renewal. Drug manufacturers must have at least one drug listing with the FDA to keep their establishment registration and NDC label code active. 

Medical Device Facilities

Foreign manufacturers of medical devices whose products are available in the US Market must identify all US Importers at the time of registration renewal. US Importers are required to identify all foreign manufacturers at the time of registration renewal. 

Food Facilities

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires food facilities that are registered with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year (2020, 2022, 2024, etc.). Therefore, food facility registrations will need to be renewed next year.

How We Can Help

Our Experts at Quality Smart Solutions can offer US regulatory compliance services for dietary supplements, foods, cosmetics, OTC drugs and medical devices.

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

30 Minutes Free Consultation
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Vitamin D Limits for NHPs are now Higher

The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was coined by the sunlight’s ability to provide levels of Vitamin D based on the level of exposure a person has. The most widely used form of Vitamin D is Cholecalciferol, which is predominately sourced from sheep’s wool otherwise known as lanolin making most Vitamin D sources non-vegan or vegetarian. 

Vitamin D is important in a large number of biological functions and processes such as helping with immune function and the development of bones and teeth as well as the absorption of calcium and phosphorus. Vitamin D is most commonly associated with international unit or IU value, however, the correct unit for the sunshine vitamin is micrograms (mcg).  Both the microgram and the IU value are listed on the product license for the Natural Product Number (NPN).  

Formerly, the highest dosage acceptable for natural health products (NHPs) was 1000 IU or 25 mcg daily. Daily doses above 25 mcg are considered prescription drugs and are on the prescription drug list.  Health Canada has since changed their decision on this. As of February 2021, the prescription drug list was amended to allow doses below 2500 IU or 62.5 mcg daily are permissible to be licensed as natural health products, values above this remain as prescription drugs. 

Fortunately, Health Canada has published a product monograph specifically for this high dose Vitamin D category.  The high dose monograph is exclusive to single ingredient products and restricts the use of such a high dose to six months without the advice of a health care practitioner or physician. Furthermore, only two claims can be made at such a high dose: 

  • Helps to prevent vitamin D deficiency
  • Vitamin D intake, when combined with sufficient calcium, a healthy diet and regular exercise may reduce the risk of developing osteoporosis in people with vitamin D deficiency

As there are many product monographs it may be difficult for one to easily identify which monographs are specific to Vitamin D. One of the easiest ways is to search Vitamin D within the natural health product ingredient database (NHPID). The entry is linked to the monographs and only displays the applicable ones. Additionally, the entry details the restrictions around the non- NHP eligibility such as below: 

  • A non-NHP because listed in the Prescription Drug List as follows: Vitamin D, in oral dosage form containing more than 62.5 µg or 2,500 International Units of Vitamin D per dosage form, or where the largest recommended daily dosage shown on the label would result in the daily intake by that person of more than 62.5 µg or 2,500 International Units of Vitamin D.

As this change in regulation is recent, there is a large opportunity to tap into this untouched market. Our Experts at Quality Smart Solutions can offer support to your needs for foods, cosmetics, OTC drugs and medical devices for North America.

How We Can Help

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

30 Minutes Free Consultation
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