Medical Devices Regulations

68.11 (1) A manufacturer of a medical device may submit to the Minister an application for an authorization for the device if it is a UPHN medical device.

(2) The application shall be submitted in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to issue the authorization, including

• (a) the name of the device;

• (b) the class of the device;

• (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

• (d) the name and address of the manufacturer as it appears on the device label;

• (e) the name and address of the establishment where the device is manufactured, if different from those referred to in paragraph (d);

• (f) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;

• (g) information respecting the safety and effectiveness of the device;

• (h) evidence that establishes that the manufacturer has a quality management system in place in respect of the device;

• (i) the directions for use, unless directions are not required for the device to be used safely and effectively;

• (j) an attestation by the manufacturer that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls; and

• (k) a copy of the device label.

(3) An application in respect of a Class III or IV medical device shall contain, in addition to the information and documents referred to in subsection (2),

• (a) a description of the materials used in the manufacture and packaging of the device; and

• (b) a list of the countries, other than Canada, where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and any recalls of the device in those countries.

(4) Despite subsection (2) and subsection (3), the application need not include the information and documents referred to in paragraphs (2)(g) and (h) and, if applicable, subsection (3) if

• (a) the application includes information that demonstrates that an authorization or licence for sale of the medical device has been issued by a regulatory agency and that the authorization or licence has not been suspended or revoked; and

• (b) the name of the regulatory agency appears in the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.