Medical Device Regulations Amended: SOR/2024-136

By: Jan Noupbaev, ASSOCIATE DELL TECH LABORATORIES

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing): SOR/2024-136

On June 17, 2024 Health Canada published to Canada Gazette, Part II amendments to the Medical Device Regulations. These changes were implemented to enhance Health Canada’s oversight of therapeutic products recalls and to align with international standards. The changes aim to address the advancing landscape of therapeutic products, and to ensure the safety and efficacy of medical devices and the health and safety of the Canadian public, while reducing the administrative burden for industry stakeholders.

Some of the changes may require medical device companies to update the standard operating procedures of their quality management system. Dell Tech has an experienced team of medical devices specialists that can help with interpreting the new medical devices regulations and to implement any changes required to ensure your company is complying.

Summary of key points

1. Definition of Recall

• The definition of “recall” has been updated to include any action taken by a manufacturer, importer, or distributor to address defective devices that may pose health risks or fail to meet regulatory claims and standards.

2. Establishment Licenses

• Contact Information Requirements: Establishment license holders must submit new contact information within 15 days of any changes.
• Terms and Conditions: The Minister may impose or amend terms and conditions on establishment licenses based on factors like compliance feasibility and health risk protection.

3. Recall Reporting and Procedures

• Voluntary Recalls: Manufacturers or importers who voluntarily recall a device must provide detailed information to the Minister within 24 hours, including device identification, reason for recall, risk evaluation and the recall strategy.
• Documentation: Detailed records of the recall process must be maintained, including communication copies, recall strategy, and actions taken to prevent recurrence.
• Risk based reporting: Recalls are now reported based on level of risk, reducing the burden for low-risk medical devices.

4. Record Keeping

• Records of recalled devices must be kept for a period equivalent to the device’s useful life plus two years, ensuring comprehensive documentation of the recall process and preventive actions.

5. Transitional Provisions and Compliance Deadlines

• Establishment license applicants and holders must update contact information and comply with new requirements by the specified deadlines to ensure continued regulatory compliance.

6. Implementation Timeline

• Most of these amendments will come into force on the 180th day after registration of the amended regulations, with specific sections taking effect immediately upon registration.

For a more detailed review of the changes, the Canada Gazette entry can be accessed at the link below:

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)

Reference:

Canada Gazette, Part II, Volume 158, Number 14

Registration

SOR/2024-136 June 17, 2024

Jan Noupbaev has 25 years of medical devices regulatory affairs and quality assurance experience and can provide guidance and support with Canadian, U.S. and European requirements. Jan joined Dell Tech as an Associate through the acquisition of MCSI.

Dell Tech has provided professional, confidential consulting services to the specialty chemical 

industry in Canada, the USA, Europe, and Asia for the last 40 years.