Regulations amending the Medical Devices Regulations to modernize the frameworks for establishment licences and recalls

MDCP Bulletin, July 26, 2024 from the Medical Devices Compliance Program

On this page

• Background
• About the amended regulations
• Summary of amendments
• What this means for MDEL Holders
• Further regulatory activities and foreign MDEL requirement
• Contact us

Background

Canada's regulatory frameworks for the post-market oversight of medical devices contain elements that can limit Health Canada's ability to:

• adapt to a changing landscape
• encourage innovation and competition

The COVID-19 pandemic further highlighted the importance of flexible regulatory frameworks, like terms and conditions, that support our ability to:

• respond to emerging risks
• continue to protect the health and safety of the public

We rely on recalls to address and correct issues that present risks to consumers. Industry stakeholders have raised concerns that the timelines and expectations for reporting voluntary recalls are unclear and create administrative burden.

The Medical Devices Regulations also needed to be updated to include a reporting framework for therapeutic product recalls. This framework was ordered by the Minister in accordance with Section 21.3 of the Food and Drugs Act.

Health Canada's commitments to modernize the regulations are outlined in the:

• Stock Review Plan
• Forward Regulatory Plan
• Health and Biosciences Sector Regulatory Review Roadmap

We invited stakeholders to review the proposed amendments on April 15, 2023. The proposed amendments were pre-published in the Canada Gazette, Part I, followed by a 75-day comment period. Feedback from stakeholders was considered when preparing these amendments to the regulations.

Learn more:

• Canada Gazette, Part 1

About the amended regulations

The amended regulations will come into force December 14, 2024, 180 days after registration on June 17, 2024. The amended regulations were published in Canada Gazette, Part II on July 3, 2024.

Summary of key amendments

Key amendments include:

• an updated definition of "recall" which includes recalls ordered by the Minister
• establishing a regulatory framework for recalls of medical devices ordered by the Minister
• clarifying industry's reporting and record-keeping obligations for recalls that they initiate
• aligning the reporting of low-risk medical device recalls with that of international regulatory agencies
• modernizing medical device establishment licence (MDEL) application requirements to reflect current practices
• giving the Minister the ability to issue terms and conditions on an MDEL to:
  • mitigate risks to health and safety
  • strategically target non-compliance
• updated wording to improve consistency in language within the regulations

These amendments represent the first phase of work to modernize the MDEL frameworks, as described in the Forward Regulatory Plan.

Learn more:

• Canada Gazette, Part II
• Forward Regulatory Plan 2024 to 2026: Modernizing the Medical Device Establishment Licensing (MDEL) Framework

What this means for MDEL holders

Once the amendments to the regulations come into force, current MDEL holders and applicants must make sure their contact information, including email address, is up to date. Current MDEL holders do not have to provide names that they previously conducted activities under until their annual licence review.

The following documents have been updated to reflect these changes:

• Guide to Recall of Medical Devices (GUI-0054)
• Guidance on Medical Device Establishment Licensing (GUI-0016)
• Medical Device Establishment License application: instructions (FRM-0292)

We've also published a new policy to describe compliance and enforcement with terms and conditions on MDELs:

• Medical Device Establishment Licence Terms and Conditions Policy (POL-0156)

For the next 6 months, we'll be working closely with regulated parties to raise awareness and promote compliance. We'll also send out bulletins on compliance promotion activities and updates on guidance documents in the future.

Further regulatory activities and foreign MDEL requirement

Health Canada will continue its modernization agenda, including assessing the requirement for foreign distributors to maintain an MDEL in accordance with 44(3) of the regulations. We plan to publish a notice of intent about reviewing the regulations in the fall of 2024. During this time, Health Canada will not prioritize enforcement of foreign MDELs for importers that hold a valid MDEL.

Contact us

Contact us if you have questions.

Email: meddev-matmed@hc-sc.gc.ca