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Drugs and Health Products

Classification of Health Products at the Device-Drug Interface

What are products at the device-drug interface?

These are products that do not readily fall within the definition of "device" or "drug" as set out in the Food and Drugs Act, and therefore present a challenge when determining which regulations apply. In Canada there are three sets of regulations which may apply to these products under the Next link will take you to another Web site 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 product is not clear, members of the Therapeutic Products Classification Committee (TPCC) may be consulted. The committee makes recommendations on the classification of a product as either a drug (pharmaceutical, biological, or natural health product), medical device, or combination product. If 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 committee's discussion. The TPCC consists of representatives from various directorates of HPFB.

The TPCC has set out the factors that influence the classification of a health product as a drug or medical device. These factors are described in the guidance document Factors Influencing the Classification of Products at the Device-Drug Interface.

Classification Recommendations

The following are notices on recent classification recommendations on products made by the TPCC at the device-drug interface.

Questions

For questions about which regulatory framework may apply to a particular health product or about the classification of products at the device-drug interface please e-mail:

Drug-Device.Classification.Drogue-Instrument@hc-sc.gc.ca

Additional Resources