The revised guidance from Health Canada on the classification of products at the (medical) device-drug interface aims to reflect the changes to the definition of (medical) device made to the Food and Drugs Act, and help bring greater clarity to how Health Canada classifies health products at the device-drug interface. The guidance document was first published on 30th January 2013, entitled “Factors Influencing the Classification of Products at the Device-Drug Interface”.
The objectives of the policy include making stakeholders aware of the factors used in the classification of a health product as either a device or a drug, and to facilitate consistent and predictable decision-making when determining the regulatory pathway for devices and drugs.
The classification of a health product determines which set of regulations it will fall under. Products at the device-drug interface are those that do not readily fall within the definition of “device” or “drug” as set out in the Food and Drugs Act, and thus present a challenge when determining which set of regulations apply. Classification guidance describes the factors that influence decisions by Health Canada, with the aim of increasing transparency and predictability.
The updated guidance is intended to assist in the classification of products at the device-drug interface when the appropriate regulatory framework is not immediately evident.
To view the revised guidance on classification of products at the (medical) device-drug interface, please click here.