Health Canada Details Investigational Testing Review Process

Health Canada released new guidance for device sponsors outlining the agency’s review process for investigational testing authorizations for unlicensed Class I-IV medical devices that will be imported or sold in Canada for investigational testing involving humans.

The agency uses the reviews to assess whether the unlicensed device can be used without threatening patients’ safety, if the study is contrary to the best interests of patients, and if the testing objectives are likely to be achieved.

Reviews are not required if there is no sale of the medical device or a study uses a licensed device for its licensed indications.