Classification of health products at the drug-medical device interface
What are health products at the drug-medical device interface?
Health products at the drug-medical device interface are those that do not readily fall within the definition of "drug" or "device" in section 2 of the Food and Drugs Act (F&DA). Under the F&DA, three sets of regulations may apply to these products:
- The Food and Drug Regulations;
- The Medical Devices Regulations; or
- The Natural Health Products Regulations.
How are health products classified at the drug-medical device interface?
Classification is the first step in the review of health products by the Health Products and Food Branch (HPFB). When the classification of a health product is not evident, the Office of Science of the Therapeutic Products Directorate is consulted. The Office of Science provides recommendations on the classification of products as either drugs (i.e., pharmaceutical, biologic, or natural health product), medical devices or drug-medical device combination products. Health product classification involves rigorous research, analysis, and consultation as necessary. It can be complex and resource-intensive. In rare cases, the Office of Science may pursue additional consultation with the Therapeutic Products Classification Committee (TPCC). The TPCC includes representatives from various areas of Health Canada, within and outside of HPFB. The guidance document titled, "Guidance Document: Classification of Products at the Drug-Medical Device Interface" describes the factors considered by Health Canada in the classification of health products as either devices or drugs.
How health product classification contributes to risk mitigation
Product classification must be carefully conducted to ensure that a health product is assigned to its appropriate regulatory category. The level of risk associated with the use of a product is not considered when determining the regulatory framework under which it falls. Nonetheless, a properly categorized product will be placed under the regulatory instrument that will allow the risks it could pose to be adequately addressed. Each set of regulations under the Food and Drugs Act includes a range of regulatory requirements that provide risk-mitigating measures proportionate to the health product's level of risk. For instance:
- The Medical Devices Regulations specify different requirements for products that pose different risks, ranging from lowest (i.e., Class I) to highest risk (i.e., Class IV). The regulatory requirements set out for Class I devices are much less rigorous than those that apply to Class IV. For example, adhesive bandages and manual toothbrushes are Class I devices and require only an establishment licence for import and sale. Class II devices such as contact lenses and syringes, Class III devices such as tooth bonding resins and hip prostheses, and Class IV devices such as bone grafts and cardiac pacemakers all require the filing of an application for a medical device licence, with the respective regulatory requirements increasing with higher risk classes.
- Drug products that require health practitioner oversight have more stringent regulatory requirements than self-care products. While all pharmaceutical drugs, including over-the-counter products, are subject to Part C, Division 1 of the Food and Drug Regulations, drugs that have not been sold in sufficient quantity or for sufficient time to establish their safety and effectiveness are also subject to additional pre-market requirements under Part C, Division 8 of the regulations.
- Licensing applications for health products under the Natural Health Products Regulations are subject to a pre-market assessment based on the file type (Class I, II or III). A Class I application requires an attestation of conformance to a single product monograph. Monographs apply to ingredients that Health Canada has reviewed for safety and efficacy. They describe the health claims, indications and conditions for the safe and effective use of the natural health product, and include important information such as safety warnings, precautions, adverse reactions, and interactions with other drugs. A Class III application requires a comprehensive data package supporting the safety, efficacy and quality of the product (e.g., a vitamin product associated with a new route of administration). The evidence requirements for a Class III application depend on the risk level of the claim or the inherent risk associated with use of the ingredient.
In addition, pre- and post-market requirements enable Health Canada to maintain oversight throughout the health product life-cycle, from the pre-market quality of design/manufacturing and testing stages, to post-market surveillance and compliance activities. Health Canada contributes to mitigating risks by: reviewing and approving clinical trial applications; conducting pre-market reviews of health product submissions and post-market changes; monitoring the safety/effectiveness of marketed health products; communicating safety concerns; and enforcing industry's compliance with regulations such as those related to clinical trials, drug manufacturing, and adverse reaction reporting.
The tiers of control under the Food and Drugs Act's different regulatory regimes enable Canadians to access health products of all risk levels that are safe and effective.
For questions about the classification of products at the drug-medical device interface or the regulatory framework that may apply to a particular health product, please contact the Office of Science.
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