Medical Devices Regulations

65.1 (1) Despite sections 64 and 65, the manufacturer of a medical device may permit the importer of the device to prepare and submit, on the manufacturer’s behalf, the information and documents with respect to the recall if the information and documents that the manufacturer and importer must submit are identical.

(2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to prepare and submit the information and documents with respect to the recall on the manufacturer’s behalf.