Draft for consultation: Guide to the exceptional importation and sale of medical devices (GUI-0147): Exceptional importation regulatory pathway

The exceptional importation pathway makes it possible to prevent and mitigate the impact of medical device shortages or risk of shortages that could present a risk of injury to human health. It allows the exceptional importation and sale of foreign authorized devices that do not fully meet Canadian regulatory requirements, but that are manufactured to comparable quality standards to Canadian authorized devices.

Health Canada interprets the risk of injury to human health due to a shortage as the likelihood that interruption, lack or delay of treatment due to a shortage could cause harm to human health.

Devices that are added to the List of Medical Devices for Exceptional Importation and Sale are only allowed to be imported for sale for:

• a specified period of time and
• a specified number of units (if specified)

The Medical Devices Regulations (MDR) define a medical device shortage as a situation in which a manufacturer of a medical device is unable to meet the demand for a device in Canada.

For information about regulatory requirements for shortage and discontinuation reporting, consult:

• Draft for consultation: Guidance for reporting medical device shortages and discontinuations (GUI-0137)

For a medical device to be allowed for exceptional importation and sale, medical device establishment licence (MDEL) holders must meet the conditions under section 62.29 of the MDR. Devices that are allowed for exceptional importation and sale are known as "designated medical devices". They are included on the List of Medical Devices for Exceptional Importation and Sale.

Health Canada amends this list as required in accordance with section 62.28 of the MDR, when available information indicates that:

• there's a shortage or risk of shortage of a Canadian authorized medical device
• there could be a risk of injury to human health from a shortage of the Canadian authorized medical device
• the device to be added to the list can be substituted for the device in shortage or at risk of shortage
• the designated medical device must be authorized to be sold by a foreign regulatory agency within its jurisdiction or must comply with all applicable legal requirements within its jurisdiction
• the device is manufactured to comparable quality standards to Canadian authorized devices

Under section 62.3, certain provisions of the MDR do not apply to designated medical devices. These include sections 21.1 to 21.2 and 26, which cover labelling and device licence requirements.

Under subsection 62.31(1), designated medical devices are subject to provisions of the MDR that cover:

• establishment licences
• maintaining distribution records
• complaint handling
• foreign risk notification
• conducting a recall
• reporting incidents and
• reporting any shortage or discontinuation

These provisions are described in sections 44 to 62.2 and sections 62.32 to 65.1. Importers, distributors, health care facilities and manufacturers that wish to import or sell designated medical devices in Canada must hold a valid MDEL. (Refer to section 62.29 of the MDR.)