Medical Devices Regulations

61.1 (1) Despite subsection 59(1) or (1.1), the manufacturer of a medical device may permit the importer of the device to prepare and submit the preliminary and final reports on the manufacturer’s behalf if the information that the manufacturer and the importer must include is identical.

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