Medical Devices Directorate Performance Annual Report

In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides detailed metrics about the timeliness of the pre-market medical devices review process against the performance service standards.

Guiding Principles for Predetermined Change Control Plans for machine learning-enabled medical devices

We previously reported on Health Canada, the US Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly publishing the Good Machine Learning Practice for Medical Device Development: Guiding Principles.

On October 24, 2023, Health Canada, FDA, and MHRA jointly published 5 further guiding principles for predetermined change control plans (PCCP), i.e., a manufacturer’s plan that specifies 1) certain planned modifications to a machine learning-enabled medical device, 2) the protocol for implementing and controlling those modifications, and 3) the assessment of impacts from those modifications.

The five guiding principles are:

1. Focused and bounded – the PCCP describes specific changes that are limited to modifications within the intended use of the original medical device.
2. Risk-based – the PCCP follows a risk-based approach that adheres to the principles of risk management.
3. Evidence-based – the PCCP is supported by evidence generated throughout the total product lifecycle of the medical device.
4. Transparent – the PCCP provides clear and appropriate information and detailed plans for ongoing transparency to users and stakeholders.
5. Total product lifestyle perspective – the PCCP follows a total product lifecycle perspective.

Regulatory enrolment process for medical devices

On November 15, 2023, Health Canada published a revised notice that the Health Products and Food Branch is implementing the regulatory enrolment process (REP) and the use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities.

The REP facilitates the filing and processing of regulatory information. The CESG is a secure method for submitting regulatory documents.

The REP is available for the following Class II, III, and IV activities:

• Licence applications
• Licence amendments
• Minor change amendments, including manufacturer name and/or address changes
• Private label applications
• Private label amendments

Starting July 2024, all medical device companies are invited to use the REP. Health Canada intends to make REP mandatory within 18 months from implementation.

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