Medical Devices Regulations (SOR/98-282)

Regulations are current to 2017-12-11 and last amended on 2017-02-13. Previous Versions

  •  (1) Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French.

  • (2) Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser.

  • (3) In respect of a medical device to be sold to the general public, the information required by paragraphs 21(1)(a) and (e) to (j) shall, as a minimum, be in both English and French.

  • SOR/2002-190, s. 3.

Contraceptive Devices — Advertising

  •  (1) For the purposes of subsections 3(1) and (2) of the Act and subject to section 27, a condom may be advertised and sold to the general public for the purpose of preventing the transmission of sexually transmitted diseases if the advertisement and the label of the condom claim only that the condom reduces the risk of transmitting sexually transmitted diseases.

  • (2) For the purpose of subsection 3(3) of the Act and subject to section 27, contraceptive devices, other than intrauterine devices, may be advertised to the general public by any means other than by the distribution of samples of the devices door-to-door or through the mail.

  • SOR/2002-190, s. 4;
  • SOR/2007-289, s. 3.

Class I Medical Devices

  •  (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that a Class I medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before a specified day, information to enable him or her to determine whether the device meets those requirements.

  • (2) The Minister may direct the manufacturer to stop the sale of a Class I medical device if

    • (a) the manufacturer does not comply with a request made pursuant to subsection (1) by the day specified in the request; or

    • (b) the Minister determines, on the basis of the information submitted pursuant to subsection (1), that the device does not meet the applicable requirements of sections 10 to 20.

  • (3) The Minister may lift the direction to stop the sale if

    • (a) the manufacturer provides the information requested;

    • (b) corrective action has been taken to ensure that the medical device satisfies the applicable requirements of sections 10 to 20; or

    • (c) the Minister’s determination was unfounded.

  • SOR/2015-193, s. 7.

Class II, III and IV Medical Devices

Prohibition

 Subject to section 37, no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence.

 No person shall advertise a Class II, III or IV medical device for the purpose of sale unless

  • (a) the manufacturer of the device holds a licence in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device licence; or

  • (b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law.

Medical Devices Deemed Licensed

 If a system is licensed, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.

 If a test kit is licensed, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.

 If a medical device or a medical device group is licensed and forms part of a medical device family or a medical device group family, as the case may be, all other medical devices or medical device groups in the family are deemed to have been licensed.

  •  (1) If all the medical devices that form part of a medical device group are licensed, that medical device group is deemed to have been licensed.

  • (2) If a medical device group is licensed, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.

Application for a Medical Device Licence

  •  (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 applicable requirements of sections 10 to 20;

    • (c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the applicable requirements of sections 10 to 20;

    • (d) a copy of the device label;

    • (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 applicable requirements of sections 10 to 20;

    • (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 applicable requirements of sections 10 to 20, 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 applicable requirements of sections 10 to 20;

    • (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 applicable requirements of sections 10 to 20;

    • (i) detailed information on all studies on which the manufacturer relies to ensure that the device meets the applicable requirements of sections 10 to 20, 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.

  • SOR/2003-173, s. 2;
  • SOR/2006-197, s. 2;
  • SOR/2015-193, ss. 4, 7.
 
Date modified: