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:
- a shift to remote work
- an increase in safety and effectiveness issues with the supply chain shift
- critical shortages of medical devices such as ventilators and personal protective equipment
- a rise in regulatory non-compliance, such as false attestations about regulatory procedures
- a surge in licenced establishments due to demand for COVID medical devices and personal protective equipment, at:
- roughly 2,800 establishments in 2019
- up to almost 6,000 establishments in 2020
- down to around 3,800 establishments in 2022
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:
- compliance and enforcement
- regulations
- business processes and information technology
- enhanced engagement
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:
- virtual inspections
- on-site inspections
- remote assessments
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:
- failing to have required procedures in place
- MDEL holders are required to document and maintain procedures and records on distribution, complaint handling and recalls
- missing annual licence renewal deadline of April 1
- not paying annual licence review fees
- If you do not pay your invoice, your application will not be processed and your MDEL will be cancelled
- not responding to Health Canada's repeat requests, such as for licensing or inspection
- failing to address annual licence review application deficiencies within the given timeline
Learn more about:
- Names of medical device establishments' senior officials to be posted
- List of Medical Devices - Notification of Shortages
- What MDEL holders need to know about annual license reviews for 2022
- Immediate suspensions of Medical Device Establishment Licenses (MDELs)
- Cancellation of MDELs for non-compliance with annual license review requirements
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:
- streamline MDEL application requirements to reflect current practices, such as requiring applicants to provide:
- previous MDEL numbers
- current or previous company identification held by the establishment
- provide the Minister with new and expanded authorities over MDELs, including the ability to:
- issue terms and conditions on an MDEL
- partially suspend or cancel an MDEL to mitigate risks to health and safety
- implement ministerial authority to:
- order recalls of medical devices
- harmonize the definition of recall
- clarify industry reporting obligations in guidance
Learn more about:
- List of Medical Devices - Notification of Shortages
- Consultation for proposed amendments to the Medical Device Regulations
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.
Learn more about:
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:
- recalls
- licencing
- shortages
- inspections
- reporting medical device problems
MDCP Bulletins provide information on our regulatory activities, process changes and current issues.
Learn more about:
Next steps
The program continues to explore new initiatives to benefit the public and industry, including:
- further automation of the annual licence review process
- adding a single window to the landing page for contacting MDCP
- permanent adoption of the electronic Manufacturer's Certificate to Export
- emailing MDCP Bulletins to a broader audience, beyond current licence holders
- an eLearning module to educate industry on medical device establishment licensing and post-market responsibilities
Current and future initiatives will result in:
- a more modern, agile, robust and sustainable program
- enhanced access to information on regulatory requirements and program changes
- continued access to safe, effective and high quality medical devices for people living in Canada
- simpler and automated processes for conducting business transactions and communicating with the program
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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