Medical Devices Regulations (SOR/98-282)

86 No person shall import or sell a medical device for investigational testing unless the device has a label that sets out

• (a) the name of the manufacturer;

• (b) the name of the device;

• (c) the statements “Investigational Device” and “Instrument de recherche”, or any other statement, in English and French, that conveys that meaning;

• (d) the statements “To Be Used by Qualified Investigators Only” and “Réservé uniquement à l’usage de chercheurs compétents”, or any other statement, in English and French, that conveys that meaning; and

• (e) in the case of an IVDD, the statements “The performance specifications of this device have not been established” and “Les spécifications de rendement de l’instrument n’ont pas été établies”, or any other statement, in English and French, that conveys that meaning.