To apply for Class II in vitro diagnostic (IVD) medical device registration in Canada, you'll need to follow the steps outlined by Health Canada. Here’s a general overview of the process:

1. Determine Device Classification

Confirm that your IVD device is classified as Class II. You can refer to the Medical Devices Regulations (SOR/98-282) for classification criteria.

2. Quality Management System (QMS)

Ensure that your manufacturing facility has a Quality Management System in place. Class II devices are required to comply with ISO 13485:2016, which outlines the QMS requirements for organizations involved in medical device manufacturing.

3. Prepare the Application

Prepare a device submission, which includes the following:

• Device Description: Include the intended use, design, and operation of the device.
• Safety and Effectiveness Data: Provide evidence supporting the safety and effectiveness of your device, such as performance testing data.
• Labeling Information: Include proposed labels, instructions for use, and any promotional materials.
• QMS Information: Include documentation demonstrating compliance with ISO 13485.

4. Submit the Application

Submit your application through the Medical Device Submission Application Form (Form 1601). You can do this electronically through Health Canada's online submission system, or by mail.

5. Pay the Fees

Pay the applicable fees associated with the submission. The fees vary depending on the device type and the complexity of the submission.

6. Health Canada Review

Health Canada will review your submission for compliance with regulatory requirements. They may request additional information or clarification during this process.

7. Obtain License

If your submission is successful, you will receive a Medical Device License (MDL) for your Class II IVD device. You must then comply with post-market surveillance and reporting requirements.

8. Post-Market Surveillance

Once your device is on the market, you are responsible for monitoring its performance and reporting any adverse events to Health Canada.

Resources

• Health Canada Website: Check the Health Canada website for specific guidance documents and detailed requirements for IVD devices.
• Guidance Documents: Review the relevant guidance documents, such as the "Guidance Document: Medical Device Licensing" and "Guidance Document: In Vitro Diagnostic Devices".

Make sure to stay updated on any changes to regulations or procedures by regularly checking Health Canada’s website or consulting with regulatory affairs experts.

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