Medical Devices Regulations

68.03 (1) Despite section 8, Part 1 does not apply in respect of the importation or sale of a medical device if the manufacturer holds an authorization for the device.

(2) However, the following provisions of Part 1 apply in respect of the importation or sale of the medical device:

• (a) in the case of an importer, sections 59 to 61;

• (b) in the case of an importer or distributor, sections 44 to 51.1; and

• (c) sections 21, 23 and 27, 52 to 58, 62 and 62.21 to 65.1.

(3) Despite paragraph (2)(b), subsection 44(3) does not apply if the medical device that is imported is a Class I device and the person from whom the device is imported is the manufacturer.