For regular updates of a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, adherence to specific standards and processes is crucial for maintaining compliance and ensuring the device's safety and effectiveness. Here’s an overview:

Standards for Regular Updates

1. ISO 13485:2016

   • Quality Management Systems: Establish and maintain a quality management system that includes procedures for document control, change management, and continuous improvement.

2. ISO 14971:2019

   • Risk Management: Regularly update risk management practices based on new data from post-market surveillance and user feedback.

3. Health Canada Guidance Documents

   • Regulatory Updates: Keep informed about changes in Health Canada's guidance that may impact the device or its labeling and marketing.

4. Labeling Standards (ISO 18113)

   • Ensure compliance with labeling and IFU standards, updating them based on changes in indications, safety information, or regulations.

Processes for Regular Updates

1. Documentation Review

   • Conduct periodic reviews of technical documents, including specifications, test data, and quality system records, to ensure they remain current and accurate.

2. Post-Market Surveillance

   • Implement an ongoing system for collecting and analyzing data on device performance and user feedback to inform necessary updates.

3. Adverse Event Monitoring

   • Track adverse events and complaints, using this data to update risk assessments and inform necessary changes to labeling and IFUs.

4. Labeling and IFU Updates

   • Regularly review and update labeling and instructions for use to reflect new information, ensuring compliance with bilingual requirements.

5. Internal Audits and Management Reviews

   • Perform internal audits of the QMS and conduct management reviews to assess compliance, effectiveness, and areas for improvement.

6. Training and Communication

   • Ensure staff are trained on updated processes, and maintain clear communication about changes to device management and compliance requirements.

7. Regulatory Submissions

   • Determine when updates require submitting amendments or new applications to Health Canada, particularly for significant changes to the device or its intended use.

8. Monitoring Regulatory Changes

   • Stay updated on changes to regulations and standards from Health Canada and other relevant authorities, adjusting practices accordingly.

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