Draft for consultation: Guide to reporting medical device shortages and discontinuations (GUI-0137): Overview
Document change log
Date | Nature of and/or reason for change: |
---|---|
Month day, year | Sections 62.221 and 62.241 were added. Sections 62.21, 62.22, 62.23, 62.24, 62.25 and 62.26 were amended. Paragraph 62.23(1)(i) was repealed. |
March 2, 2022 | Sections 62.21 to 62.26 were added to the regulations to make medical device shortages and discontinuations reporting permanent. |
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 reporting of medical device shortages and discontinuations.
Health Canada is responsible for helping the people of Canada maintain and improve their health. This is done, in part, through 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 62.21 to 62.26 of the MDR.
These sections require manufacturers of Class I to IV medical devices and importers of Class I medical devices to:
- report shortages of specified medical devices (including their components, accessories and parts)
- report the decision to discontinue the sale of a specified medical device in Canada
- establish and maintain documented procedures for reporting medical device shortages and discontinuations of specified medical devices (including their components, accessories and parts)
A specified medical device is a medical device that is part of a category of medical devices that is set out in the List of Medical Devices – Shortages and Discontinuation of Sale. This list is referred to as the List of specified medical devices on our web page.
These sections also permit the Minister of Health to require a manufacturer, importer or distributor to provide information requested about a medical device shortage.
Scope and application
The guidance will help manufacturers, importers and distributors meet their regulatory obligations. It explains the responsibilities for the mandatory reporting of medical device shortages and discontinuations, establishing and maintaining documented procedures, and other information requests as set out in the legislation.
This document also provides information on how to voluntarily report a shortage of a medical device that's not on the list. Although Health Canada's role is focused on administering the requirements for mandatory shortage and discontinuation reporting, voluntary reports can help us monitor or determine if there is a risk of shortage for categories of devices that are not listed.
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.
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