To apply for a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, you will need to follow specific steps and utilize the appropriate resources. Here’s a detailed guide on how to apply and where to handle the process:

Step-by-Step Application Process

1. Confirm Device Classification

• Ensure that your device is classified as Class II according to Health Canada’s classification guidelines. Class II devices are typically moderate-risk IVDs.

2. Prepare Required Documents

• Gather all necessary documentation, including:
  • Completed Form 3011 (MDL Application)
  • Quality Management System (QMS) Certification (ISO 13485 and MDSAP)
  • Device Description and Technical Specifications
  • Intended Use and Indications
  • Performance Testing and Validation Data
  • Labeling and Instructions for Use (IFU)
  • Summary of Safety and Effectiveness (optional)
  • Proof of Payment for Application Fees

3. Complete Form 3011

• Fill out Form 3011 accurately. This form collects essential information about your device, manufacturer details, and QMS compliance.

4. Submit Your Application

• Electronic Submission:

  • Use the Medical Device eSubmission System (MDEL Portal) for online submissions. This is the preferred method as it provides real-time tracking and updates.
  • Link to the eSubmission system: Medical Device eSubmission.

• Mail Submission (if necessary):

  • If you cannot submit electronically, you may send your application by mail. Ensure all documents are included.

Pay the Application Fee

• Pay the applicable application fee, which for Class II devices is typically between CAD $5,000 and CAD $6,000. Small businesses may qualify for a fee reduction.
• Include proof of payment with your submission if submitting by mail.

6. Health Canada Review

• Health Canada will review your application, which typically takes about 60 calendar days. They may contact you for additional information or clarification.
• Ensure that you respond promptly to any requests to avoid delays.

7. Receive MDL Approval

• If your application is approved, you will receive your Medical Device License (MDL), allowing you to market and sell your Class II IVD in Canada.

Where to Handle the Application

• Health Canada: The primary authority for the MDL application process is Health Canada, specifically the Medical Devices Directorate. All submissions and inquiries should be directed to them.
• Online Resources:
  • Health Canada’s official website provides comprehensive guidance, forms, and information on medical devices: Health Canada - Medical Devices.
  • The eSubmission system is the main platform for handling electronic applications.

Additional Considerations

• Prepare Thoroughly: Ensure all documentation is complete, accurate, and formatted professionally to minimize delays in processing.
• Track Your Application: Use the eSubmission system to monitor the status of your application.
• Post-Market Compliance: After obtaining the MDL, be prepared to adhere to post-market surveillance requirements and reporting obligations.

By following these steps and utilizing the resources provided by Health Canada, you can successfully navigate the application process for a Class II IVD MDL registration in Canada.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn