Draft for consultation: Guide to the exceptional importation and sale of medical devices (GUI-0147): Overview
Document change log
Date | Nature of and/or reason for change: |
---|---|
MM DD, Year | Section 62.321 was added. Sections 62.27, 62.28(b), 62.29, 62.29(c)(i) to (iii), 62.29(c)(v) and (vi), 62.29 (d) and (e) were amended. Paragraph 62.29(b) was repealed. |
March 2, 2022 | Sections 62.27 to 62.32 were added to the regulations to make exceptional importation a permanent pathway. |
This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.
Disclaimer: This document does not constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to help the regulated party comply with the legislation and the applicable administrative policies.
On this page
- Introduction
- Purpose
- Scope and application
- Sex- and gender-based analysis plus (SGBA Plus): Advancing equity, diversity and inclusion
- Note about guidance documents in general
Introduction
Since March 2022, regulations have been in place in the Medical Devices Regulations (MDR) that support the exceptional importation and sale of medical devices.
Health Canada is responsible for helping the people of Canada maintain and improve their health. This is done, in part, by our commitment and actions to help address and mitigate the harm to public health caused by medical device shortages so that people in Canada have access to the medical devices they need when they need them.
Learn more about medical device shortages and the roles of various parties in addressing them.
Purpose
This guidance document supports sections 62.27 to 62.321 of the MDR. The MDR give Health Canada the framework needed to allow the exceptional importation and sale of medical devices not currently authorized in Canada.
The exceptional importation regulatory pathway helps to prevent and mitigate shortages of Canadian authorized devices where such a shortage could cause risk of injury to human health.
Scope and application
This guidance document will help medical device establishment licence (MDEL) holders and retailers understand the regulatory requirements for the exceptional importation and sale of medical devices.
In accordance with the MDR, MDEL holders seeking to import and sell a foreign-authorized device are required to:
- propose that medical devices be added to the List of Medical Devices for Exceptional Importation and Sale
- provide certain information to Health Canada to aid in the review of the proposal
- provide a notification of importation
- ensure that information for the safe use of the medical device is accessible to users in English and French
- retailers are required to make sure this information is provided to the consumer
- notify Health Canada of any changes to a foreign authorization associated with the medical device
Sex- and gender-based analysis plus (SGBA Plus): Advancing equity, diversity and inclusion
Health Canada has a formal, corporate commitment to applying a sex- and gender-based analysis plus (SGBA Plus) approach to develop, implement and evaluate our activities. This includes our research, surveillance, legislation, policies, regulations, programs and services. This is in keeping with the federal government’s commitment to gender-based analysis plus (GBA Plus).
The SGBA Plus process is an intersectional approach to assess how a range of factors interact and intersect with each other and broader systems of power. Examples of factors are sex, gender, age, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status and geographic location.
Conducting this analysis helps us to understand how intersecting identity factors, histories, power relations, distribution of resources and individuals’ lived realities contribute to differences in accessing health-related resources and health outcomes. By applying SGBA Plus, we can engage in responsive and inclusive health research and develop policies, services, programs and other initiatives to promote greater health equity.
When engaging in this regulatory framework, we encourage you to conduct an SGBA Plus analysis and also take necessary steps to mitigate any possible negative impacts on particular groups.
Learn more about SGBA Plus analysis and assessment:
- Sex- and gender-based analysis plus
- Health portfolio sex and gender-based analysis policy
- Take the gender-based analysis plus course
Note about guidance documents in general
Guidance documents provide assistance to industry on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that Health Canada may consider alternative approaches to meeting the regulatory requirements that stakeholders may propose. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. Stakeholders should discuss their proposals with Health Canada in advance so that the regulator can determine whether the applicable statutory or regulatory requirements can be met.
In accordance with its regulatory authorities and its mandate under the Food and Drugs Act, Health Canada may request other information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the relevant sections of the regulations and other applicable guidance documents.
Page details
- Date modified: