Guidance for exceptional importation and sale of medical devices

Disclaimer

This document does not constitute part of the Food and Drugs Act (the Act) or its regulations. In the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

About this guide

This guidance document supports new amendments made to sections 62.27 to 62.32 of the Medical Devices Regulations (Regulations). The amendments give Health Canada the regulatory tools needed to allow the exceptional importation and sale of medical devices, in order to help track, prevent and mitigate shortages.

The amendments to the Regulations come into effect on March 2, 2022.

Who this guide is for

This guidance document will help importers, distributors, manufacturers and other establishment licence holders understand their regulatory requirements for the exceptional importation of medical devices. It is directed to:

importers or distributors
foreign manufacturers

Under the regulatory requirements, licence holders are required to:

request that medical devices be put on the List of medical devices for exceptional importation and sale
provide a notification of importation
ensure that information for the safe use of the medical device is accessible to users

The exceptional importation framework

The exceptional importation framework makes it possible to address medical device shortages (actual or anticipated). It permits the exceptional importation and sale of devices that do not fully meet Canadian regulatory requirements, but that are manufactured to comparable quality standards.

A medical device shortage occurs when a manufacturer of a medical device is unable to meet Canadian market demand for the device or its components, accessories or parts.

Health Canada publishes verified medical device shortages on the Medical device shortages: List of shortages.For more information about regulatory requirements for shortage reporting, please consult the Guidance for reporting medical device shortages and discontinuations.

For a medical device to be authorized, establishment licence holders must meet the conditions under section 62.29. Devices that are authorized for exceptional importation and sale are known as "designated medical devices". They are included in 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 Regulations, when available information indicates that:

there's a shortage or risk of shortage of another medical device and
the device to be added to the list can act as a substitute for it

In addition, the designated device must be authorized in another jurisdiction or must meet with the applicable legal requirements within its jurisdiction.

Under section 62.3, certain provisions of the Regulations do not apply to medical devices brought to Canada by exceptional importation. These include sections 21 to 21.2 and 26, which cover labelling and device licence requirements.

Under section 62.31(1), designated medical devices are subject to provisions of the Regulations covering establishment licences, maintaining distribution records, complaint handling, conducting a recall or reporting incidents and any shortage to Health Canada. These provisions are described in sections 44 to 62.2 and sections 62.32 to 65.1. Importers, distributors and manufacturers seeking to import or sell designated medical devices in Canada must hold a valid medical device establishment licence (MDEL).

How to submit an application

An establishment that holds an active MDEL may ask Health Canada to add a medical device to the List of medical devices for exceptional importation and sale when there is a known or expected shortage.

To do so, complete the following form and submit it to Health Canada at md-exceptional.import.sale-import.vent.exceptionnellei-im@hc-sc.gc.ca.

Medical Devices for Exceptional Importation and Sale Request Form

Health Canada may also add a medical device to the list without having received an application.

Notification

Establishments must notify Health Canada at least 5 business days before the day on which a designated device is imported (consult section 62.29(a) of the Regulations). This notification is required for each shipment, and must include information on the establishment and designated device.

Failure to notify Health Canada within this timeframe may lead to compliance and enforcement actions.

Health Canada undertakes compliance and enforcement activities in accordance with the Compliance and enforcement policy for health products (POL-0001). This policy describes our compliance and enforcement approach for all health products regulated under the Food and Drugs Act and its regulations.

Compliance and enforcement actions are based on risk and the level of non-compliance. Actions may include removing the approved designated device from the List for exceptional import and sale.

To provide notification of the pending importation of a designated device, complete and submit the following information to Health Canada at md-exceptional.import.sale-import.vent.exceptionnellei-im@hc-sc.gc.ca:

Medical Device Exceptional Importation and Sale Notification Form

Required information

When notifying Health Canada, an establishment must provide the following information (refer to Section 62.29(a) of the Medical Devices Regulations):

establishment name and contact information
- contact name, company name, company's MDEL number, Health Canada company identification number (6 digits) (if known) and contact information (telephone, email and address)
device information
- name of the device and of any component, part or accessory of the device, including the model name (if applicable)
- identifier of the device and any medical device that's part of a system, test kit, medical device group, medical device family or medical device group family, including (if applicable or available):
  - name as per the product label
  - licensing information, such as the medical device licence (MDL) or MDEL number
  - identifiers such as the bar code, catalogue, model or part number
manufacturer information
- contact name, company name, Health Canada company identification number (6 digits) (if known) and contact information (telephone, email and address)
- this should be consistent with the manufacturer information as it appears on the device label
manufacturing site information, if it differs from that of the manufacturer
- company name and Health Canada company identification number (6 digits) (if known)
- address of manufacturing site
purpose, intended use, performance specifications
- detailed description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented
- performance specifications of the device if those specifications are necessary for proper use
- proof of safety and effectiveness requirements of the device as described under sections 10 to 20 of the Regulations
- if applicable, the applicant is to provide a description of how the device may not comply with the regulatory requirements under normal circumstances (for example, non-bilingual labelling, expired product, different intended use)
- any special storage conditions applicable to the device
intended port of entry into Canada
- name of the airport, land crossing or sea port
estimated arrival date
- estimated day, month and year of the arrival of the device shipment
number of units
- total number of individual device units to be imported on the referred to estimated arrival date

Ensure information is accessible

The labelling requirements under sections 21 to 21.2 and the medical device licensing requirements under section 26 of the Regulations do not apply to the importation of a designated device.

Section 62.32(1) of the Medical Devices Regulations requires that information described in 62.29(a)(ii)(E) about an imported medical device must be made available in English and French. An establishment must have the information below available to permit the safe and effective use of the device:

a detailed description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented
the performance specifications of the device, if those specifications are necessary for proper use

This information must be made available until either:

the expiry date of the medical device (refer to section 62.32 (2) of the Regulations) or
the end of the projected useful life of whichever of the imported devices has the latest projected useful life (refer to section 62.32 (3) of the Regulations)

The level of detail provided for the product description and performance specification may vary depending on the type and complexity of the product. For example, the description and performance specifications of a surgical mask may be less detailed than for a ventilator. If the intended use is not specified on the label of the device, then the intended use may be inferred from that accepted in general medical practice.

Acceptable examples of information include:

information bulletins or fact sheets in hard copy, which accompany the device and
information bulletins or fact sheets posted on the manufacturer's website, which are referenced on the device's label

How long a designated device may be imported or sold

Exceptional importation of designated medical devices may be permitted until the end date set out on the List of medical devices for exceptional importation and sale (described in section 62.29(c) of the Regulations). Health Canada determines the duration permitted for exceptional importation of the medical device on a case-by-case basis. Health Canada may also remove a device from the list if a shortage has been resolved. To alleviate known or anticipated shortages, Health Canada may also specify in advance a specific number of shipments, batches or other metrics to describe the amount of product permitted for import.

A medical device imported using this framework can be sold up to its expiry date (if applicable) or 2 years after the final permitted date of importation set out in the List of medical devices for exceptional importation and sale (sub-section 62.29(c)(vi)), whichever is sooner. Any medical device that was already imported under Interim Order No.2 respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19 can also continue to be sold under the same conditions as a product imported under these amendments.

Definitions

Designated medical device: a medical device that's set out in the List of medical devices for exceptional importation and sale

Distributor: a person:

other than a manufacturer, an importer or a retailer who sells a medical device in Canada for the purpose of resale or use, other than for personal use
outside of Canada who sells medical devices into Canada

Importer: a person in Canada, other than the manufacturer of a device, who's responsible for the medical device being brought into Canada for sale

List of medical devices for exceptional importation and sale: means the List of medical devices for exceptional importation and sale that's published by the Government of Canada on its website, as amended from time to time.

List of medical devices: Notification of shortages: the Government of Canada's List of medical devices – Notification of shortages, as amended from time to time

Manufacturer: a person who:

sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person and
is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf

Medical device: a device within the meaning of the Food and Drugs Act, but does not include any device intended for use in relation to animals

Name of the device: includes any information necessary for the user to identify the device and to distinguish it from similar devices

Shortage: for a medical device, a situation in which the manufacturer of the device is unable to meet the demand for the device in Canada

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Date modified:: 2022-03-01

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