Health Canada is modernizing and transforming the Medical Devices Compliance Program

MDEL Bulletin, July 21, 2022, from the Medical Devices Compliance Program

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Why we're making changes

Similar to regulatory agencies around the world, we're modernizing and transforming the program to keep pace with scientific, market and supply chain developments. The COVID-19 pandemic has also driven change as a result of significant challenges, including:

These challenges have fuelled a drive to build a more modern, agile, robust and sustainable program.

Recent changes

The program is modernizing and transforming its operations in 4 main areas:

To date, the program has implemented several modernization and transformation initiatives.

Strengthen compliance and enforcement

Inspections are being diversified to include, as part of the routine process:

Senior officials must attest on the Medical Device Establishment Licence (MDEL) application to having the required procedures in place. The program posts these names as a behavioural nudge to compliance.

The program stepped up enforcement action for non-compliance by cancelling and suspending establishment licences for:

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Modernize compliance and enforcement oversight through regulatory amendments

The Medical Devices and Compliance Program requires manufacturers and importers to report shortages and discontinuations that could lead to a shortage of medical devices on the List of Medical Devices - Notification of Shortages.

Health Canada has issued a notice of intent on proposed regulatory amendments to the Medical Devices Regulations and Food and Drugs Act. The proposed regulatory amendments would:

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Streamline and modernize business processes and use of information technology

The program has streamlined and automated initial screening of annual licence review applications. It has also shifted from paper-based to electronic processes. The program launched a pilot project to implement an electronic version of the Manufacturer's Certificate to Export.

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Enhanced engagement

Program management meets bi-weekly with industry associations, including Medtech Canada, to discuss issues and updates.

Our new landing page gives industry all the information it requires on medical devices, such as:

MDCP Bulletins provide information on our regulatory activities, process changes and current issues.

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Next steps

The program continues to explore new initiatives to benefit the public and industry, including:

Current and future initiatives will result in:

Keep informed about future changes

Over the next few years, the program will continue to modernize and transform. Health Canada is committed to keeping industry informed about key program developments through regular online bulletins. All licence holders are notified of new postings by email.

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