Health Canada Clarifies Factors Used for Medical Device Classifications

Health Canada updated its classification guidance to give industry more clarity on the factors it uses to determine whether a product is a medical device or drug.

Effective Feb. 7, the new guidance updates the agency’s January 2013 guidance to reflect revisions to the definition of a medical device under Canada’s Food and Drugs Act in November 2014, and Health Canada’s interpretations, though it does not apply to combination products.

The regulatory body pointed to the last paragraph in the Act’s definition of a medical device as a significant 2014 addition intended to clarify which products fall outside of its scope. Another key component of the definition relates to the product’s purpose or intended use, one of the factors used in making classification decisions.

“A liquid for use as a body cavity filler... could be classified as a drug when considering only paragraph (a) of the drug definition,” Health Canada said. “However, since it is intended to play a structural role once it has filed the volume of a cavity, it is best characterized as an article that modifies a body structure” and thus it would “more reasonably be classified as a device.”