To apply for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, you need to follow a specific process that involves submitting your application to Health Canada. Here’s a detailed guide on how and where to apply:

Where to Apply:

The application for the Medical Device Establishment License (MDEL) for a Class I IVD device must be submitted to Health Canada. You will apply through the Health Canada Medical Device Licensing System (MDLS), which is part of the Electronic Submission System (ESS).

Steps to Apply for the MDEL:

1. Prepare the Required Documents

Before applying, make sure you have all the required documents prepared for the application. This includes:

• Self-Declaration of Conformity: A statement confirming that your device meets Health Canada's Medical Device Regulations (MDR).
• Device Labeling: Proper labeling of the device, including manufacturer information, intended use, warnings, and instructions for use.
• Device Description: A detailed description of the device, including how it works, its components, and intended outcomes.
• Quality Management System (QMS) Information (optional but recommended): Although ISO 13485 is not mandatory for Class I devices, it is recommended to have a quality management system.
• Risk Management Information (optional): A risk management plan outlining how risks associated with the device are mitigated.

2. Create an Account in the Electronic Submission System (ESS)

To submit the application online, you need to create an account with Health Canada's Electronic Submission System (ESS).

• Visit the Health Canada website to create an ESS account.
• The account allows you to submit applications and track their progress.

3. Submit the Application via the Medical Device Licensing System (MDLS)

After creating your ESS account, you can submit the MDEL application through the Medical Device Licensing System (MDLS). This system allows you to:

• Fill out the MDEL application form.
• Upload required documentation (e.g., self-declaration, labeling, device description).
• Pay the required application fee.

4. Pay the Application Fee

There is an application fee for submitting your MDEL application. The fee for Class I devices is typically in the range of CAD $5,000 to CAD $10,000. You will also need to pay an annual maintenance fee once your MDEL is issued.

5. Health Canada Review

After submission, Health Canada will review your application. This process typically takes around 30 to 90 days. If the application is complete and meets all regulatory requirements, Health Canada will issue your MDEL.

• In some cases, Health Canada may request additional information or clarification before issuing the license.

6. Receive the MDEL

Once your application is approved, Health Canada will issue the Medical Device Establishment License (MDEL). This license allows you to sell and distribute your Class I IVD device in Canada.

7. Post-Market Surveillance and Compliance

After receiving your MDEL, you must comply with post-market surveillance requirements, including:

• Reporting adverse events associated with your device.
• Implementing recall procedures if any issues arise with the device.

Where to Apply (Web Portal)

• You will submit your MDEL application via the Health Canada Medical Device Licensing System (MDLS).
  • Health Canada's MDLS Portal: Health Canada - Medical Device Licensing System

By following these steps and using the MDLS portal to submit your application, you can apply for the Class I in vitro diagnostic medical device MDL registration in Canada.

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