Medical Devices Regulations

32 (1) An application for a medical device licence shall be submitted to the Minister by the manufacturer of the medical device in a format established by the Minister and shall contain the following:

• (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; and

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

(2) An application for a Class II medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

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

• (b) a list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements;

• (c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the safety and effectiveness requirements;

• (d) an attestation by a senior official of the manufacturer that the device label meets the applicable labelling requirements of these Regulations;

• (e) in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and

• (f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.

(3) An application for a Class III medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

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

• (b) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;

• (c) 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;

• (d) a list of the standards complied with in the design and manufacture of the device to satisfy the safety and effectiveness requirements;

• (e) in the case of a device to be sold in a sterile condition, a description of the sterilization method used;

• (f) a summary of all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness requirements, and the conclusions drawn from those studies by the manufacturer;

• (g) a copy of the device label;

• (h) in the case of a near patient in vitro diagnostic device, a summary of investigational testing conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use;

• (i) a bibliography of all published reports dealing with the use, safety and effectiveness of the device; and

• (j) a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.

(4) An application for a Class IV medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

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

• (b) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;

• (c) 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;

• (d) a risk assessment comprising an analysis and evaluation of the risks, and the risk reduction measures adopted to satisfy the safety and effectiveness requirements;

• (e) a quality plan setting out the specific quality practices, resources and sequence of activities relevant to the device;

• (f) the specifications of the materials used in the manufacture and packaging of the device;

• (g) the manufacturing process of the device;

• (h) a list of the standards complied with in the design and manufacture of the device to satisfy the safety and effectiveness requirements;

• (i) detailed information on all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness requirements, including

  • (i) pre-clinical and clinical studies,

  • (ii) process validation studies,

  • (iii) if appropriate, software validation studies, and

  • (iv) literature studies;

• (j) in the case of a medical device other than an in vitro diagnostic device, manufactured from or incorporating animal or human tissue or their derivative, objective evidence of the biological safety of the device;

• (k) in the case of a near patient in vitro diagnostic device, detailed information on investigational testing conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use;

• (l) a summary of the studies referred to in paragraph (i) and the conclusions drawn from those studies by the manufacturer;

• (m) a summary of the investigational testing referred to in paragraph (k) and the conclusions drawn from that testing by the manufacturer;

• (n) a bibliography of all published reports dealing with the use, safety and effectiveness of the device;

• (o) a copy of the device label; and

• (p) a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.