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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2019-07-01 and last amended on 2019-06-17. Previous Versions

PART 3Medical Devices for Investigational Testing Involving Human Subjects (continued)

Labelling

 No person shall import or sell a medical device for investigational testing unless the device has a label that sets out

  • (a) the name of the manufacturer;

  • (b) the name of the device;

  • (c) the statements “Investigational Device” and “Instrument de recherche”, or any other statement, in English and French, that conveys that meaning;

  • (d) the statements “To Be Used by Qualified Investigators Only” and “Réservé uniquement à l’usage de chercheurs compétents”, or any other statement, in English and French, that conveys that meaning; and

  • (e) in the case of an IVDD, the statements “The performance specifications of this device have not been established” and “Les spécifications de rendement de l’instrument n’ont pas été établies”, or any other statement, in English and French, that conveys that meaning.

Advertising

 No person shall advertise a medical device that is the subject of investigational testing unless

  • (a) that person holds an authorization issued under subsection 83(1) to sell or import the device; and

  • (b) the advertisement clearly indicates that the device is the subject of investigational testing, and the purpose of the investigational testing.

Other Requirements

 The requirements set out in the following provisions apply to medical devices to which this Part applies:

  • (a) sections 52 to 56 with respect to distribution records;

  • (b) sections 57 and 58 with respect to complaint handling;

  • (c) sections 59 to 61.1 with respect to mandatory problem reporting;

  • (d) sections 63 to 65.1 with respect to recalls; and

  • (e) sections 66 to 68 with respect to implant registration.

  • SOR/2002-190, s. 9

PART 4Export Certificates

  •  (1) For the purposes of section 37 of the Act, Schedule 3 sets out the form to be used for an export certificate for medical devices.

  • (2) The export certificate shall be signed and dated by

    • (a) where the exporter of the device is a corporation,

      • (i) the exporter’s senior executive officer in Canada,

      • (ii) the exporter’s senior regulatory officer in Canada, or

      • (iii) the authorized agent of the person referred to in subparagraph (i) or (ii); or

    • (b) where the exporter of the device is an individual,

      • (i) the exporter, or

      • (ii) the exporter’s authorized agent.

 No person shall sign an export certificate that is false or misleading or that contains omissions that may affect its accuracy and completeness.

 The exporter of a device shall maintain, at their principal place of business in Canada, records that contain the completed export certificates and shall, when requested to do so by an inspector, submit the export certificates for examination.

 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.

Repeal

 [Repeal]

Coming into Force

  •  (1) Subject to subsections (2) to (5), these Regulations come into force on July 1, 1998.

  • (2) Section 32, except paragraphs (2)(f), (3)(j) and (4)(p), comes into force

    • (a) in the case of a medical device referred to in section 94 or 95, on September 1, 1998;

    • (b) in the case of any other medical device, on July 1, 1998.

  • (3) Paragraphs 32(2)(f), (3)(j) and (4)(p) come into force on January 1, 2003.

  • (4) Sections 43 and 44 come into force on January 1, 1999.

  • (5) Sections 45 to 51 come into force on November 1, 1998.

  • SOR/2001-217, s. 1
 
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