Classification of Health Products at the Device-Drug Interface
What are products at the device-drug interface?
These are health products that do not readily fall within the definition of "device" or "drug" in section 2 of the Food and Drugs Act. In Canada there are three sets of regulations which may apply to these products under the Food and Drugs Act including:
How are products classified at the device-drug interface?
Classification of products is the first step in any regulatory review process at 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. If necessary, the members of the Therapeutic Products Classification Committee (TPCC) are further consulted. The TPCC consists of representatives from various directorates within HPFB. The committee provides recommendations on the classification of products as either medical devices, drugs (i.e., pharmaceutical, biological, or natural health product), or device-drug combination products. When a product does not readily meet one of the definitions provided in the Food and Drugs Act, other regulatory areas of Health Canada are asked to participate in the TPCC discussions. The guidance document titled Classification of Products at the (Medical) Device-Drug Interface describes the factors considered by Health Canada in the classification of health products as either devices or drugs.
The following are notices on recent classification recommendations for products at the device-drug interface.
For questions about he classification of products at the device-drug interface and about which regulatory framework may apply to a particular health product, please e-mail:
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