Medical Devices Regulations (SOR/98-282)

22. (1) Subject to subsection (2), if a medical device is intended to be sold to the general public, the information required by subsection 21(1) shall

• (a) be set out on the outside of the package that contains the device; and

• (b) be visible under normal conditions of sale.

(2) Where a package that contains a medical device is too small to display all the information in accordance with section 21, the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sale.

23. (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.

24. (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.

25. (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 safety and effectiveness requirements, 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 safety and effectiveness requirements.

(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 safety and effectiveness requirements; or

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