Medical Devices Regulations (SOR/98-282)

82. An application for an authorization referred to in subsection 80(2) shall be made in writing to the Minister and shall contain

• (a) in the case of a Class II medical device or a Class III or IV in vitro diagnostic device that is not used for patient management, not including a near-patient in vitro diagnostic device, the information set out in paragraphs 81(a), (b) and (h) to (j); and

• (b) in the case of a Class III or IV medical device that is not covered by paragraph (a), the information and documents set out in section 81.

• 83. (1) The Minister shall issue an authorization referred to in subsection 80(2) to a manufacturer or importer if the Minister determines that

  • (a) the device can be used for investigational testing without seriously endangering the life, health or safety of patients, users or other persons;

  • (b) the investigational testing is not contrary to the best interests of patients on whom the testing will be conducted; and

  • (c) the objective of the testing will be achieved.

• (2) The authorization referred to subsection (1) shall specify

  • (a) the name of any qualified investigator to whom the device may be sold;

  • (b) the type of diagnosis or treatment for which the device may be sold;

  • (c) the number of units of the device that are authorized to be sold; and

  • (d) the protocol according to which the investigational testing is to be conducted.

84. If the information and documents submitted in respect of an application made pursuant to section 82 are insufficient to enable the Minister to determine whether the conditions set out in subsection 83(1) have been met, the manufacturer or importer shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.

• 85. (1) The Minister may, in respect of a medical device in relation to which investigational testing is being conducted, request the manufacturer or importer of the device to submit information in respect of the testing if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that one of the following conditions may exist:

  • (a) the testing seriously endangers the life, health or safety of patients, users or other persons;

  • (b) the testing is contrary to the best interests of patients on whom the testing is being conducted;

  • (c) the objective of the testing will not be achieved;

  • (d) the qualified investigator who is conducting the testing is not respecting the undertaking required by paragraph 81(k); or

  • (e) the information submitted in respect of the testing is false or misleading.

• (2) If the information requested pursuant to subsection (1) is not submitted, or if it is submitted and the Minister determines after reviewing it that a condition identified in that subsection exists, the Minister may, by written notice giving reasons,

  • (a) in the case of a Class I device, direct the manufacturer or importer of the device to stop selling the device to any qualified investigator named in the notice; or

  • (b) in the case of a Class II, III or IV device, cancel the authorization referred to in subsection 83(1), in whole or in part.