Medical Devices Regulations (SOR/98-282)

Regulations are current to 2014-09-01 and last amended on 2011-12-16. Previous Versions

 The exporter of a device shall retain the export certificate for a period of not less than five years after the date of export.

PART 5TRANSITIONAL PROVISIONS, REPEAL AND COMING INTO FORCE

Transitional Provisions

 For the purposes of sections 94 and 95, “old regulations” means the Medical Devices Regulations, C.R.C., c. 871, and “Director” has the meaning assigned to it by those regulations.

  •  (1) Subject to subsection (2), if an application for a notice of compliance has been submitted with respect to a medical device pursuant to Part V of the old regulations but has not been processed by the Director as of June 30, 1998, an application for a medical device licence shall be made pursuant to these Regulations.

  • (2) For the purposes of an application for a medical device licence, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if a notice of compliance with respect to the device had been issued under the old regulations.

  •  (1) A medical device that, on June 30, 1998, is being sold in Canada pursuant to the old regulations is not required to be licensed until February 1, 1999, if,

    • (a) in the case of a device that is subject to Part V of the old regulations, the manufacturer

      • (i) has a notice of compliance in respect of the device that is in effect on June 30, 1998, or

      • (ii) does not have a notice of compliance in respect of the device that is in effect on June 30, 1998, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device; and

    • (b) in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device.

  • (2) If an initial application for licensing of a medical device that is referred to in subsection (1) is submitted before February 1, 1999, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if

    • (a) in the case of a device that is subject to Part V of the old regulations, the manufacturer

      • (i) has a notice of compliance in respect of the device that is in effect on June 30, 1998, or

      • (ii) does not have a notice of compliance that is in effect on June 30, 1998, in respect of the device, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device;

    • (b) in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device.

  • (3) Subsections (1) and (2) cease to apply in respect of a medical device if a change described in section 34 is made in respect of the device or if the notice of compliance is suspended or cancelled under section 40 of the old regulations.

  • (4) For the purposes of this section, a notice of compliance may be suspended or cancelled under section 40 of the old regulations as if that section were still in force.