Medical Devices Regulations

62.23 (1) Subject to subsections (2), (7) and (9), if a shortage of a specified medical device exists or is likely to occur, the manufacturer of the device and, in the case of a Class I device, the importer of the device shall each provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:

• (a) the name and contact information of the manufacturer and, if the information is provided by the importer, the name and contact information of the importer;

• (b) in the case of a licensed device, the medical device licence number;

• (b.1) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;

• (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

• (d) the name of the device, including, if applicable, the model name, in English and French;

• (e) a description of the device and of its packaging and an indication of whether it is a single-use device;

• (f) the date when the shortage began or is anticipated to begin;

• (g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated;

• (h) the reason for the shortage; and

• (i) a summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur.

(2) If the manufacturer of a specified medical device decides to discontinue the sale of the device in Canada, the following rules apply:

• (a) the manufacturer or importer is required to provide only the information referred to in paragraphs (1)(a) to (f) in respect of the shortage that results from the decision and shall also provide under subsection (1) the reason for the discontinuation; and

• (b) paragraph 4(a) does not apply to the manufacturer.

(3) For greater certainty, subsections (1) and (2) do not remove the requirement for

• (a) a manufacturer that is the holder of a medical device licence to inform the Minister under subsection 43(3); or

• (b) a manufacturer that is the holder of an authorization issued under section 68.12 to inform the Minister under section 68.25.

(4) Subject to subsection (8), the information that is required under subsection (1) shall be provided

• (a) if the manufacturer or importer did not anticipate the shortage, within five business days after the day on which the manufacturer or importer becomes aware of it; and

• (b) if the manufacturer or importer anticipates that there will be a shortage, within five business days after the day on which the manufacturer or importer anticipates it.

(5) If any of the information that was provided under subsection (1) changes, the manufacturer or importer shall provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.

(6) Within two business days after the day on which the manufacturer is again able to meet the demand for the specified medical device, the manufacturer or importer shall notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer’s ability to do so.

(7) The manufacturer or importer need not provide the information that is required under subsection (1) if, within the applicable period referred to in paragraph (4)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.

(8) Despite subsection (7), if the manufacturer or importer subsequently concludes that the manufacturer will be unable to meet the demand within the 30-day period, the manufacturer or the importer shall provide the information that is required under subsection (1) within five business days after the day on which the manufacturer or importer reaches that conclusion.

(9) The manufacturer or importer need not provide the information that is required under subsection (1) if the manufacturer

• (a) is also the manufacturer of another medical device that can be substituted for the specified medical device in respect of which a shortage exists or is likely to occur; and

• (b) is able to meet the demand for the substitute medical device.