Medical Devices Regulations

65.1 (1) A manufacturer of a medical device who recalls the device without being ordered to do so by the Minister may permit the importer of the device to prepare and submit, on the manufacturer’s behalf, the information and documents that are required to be provided under sections 63.2, 64 and 65 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 referred to in subsection (1) on the manufacturer’s behalf.