The process for applying for the Class I in vitro diagnostic (IVD) medical device MDL (Medical Device License) registration in Canada is relatively straightforward, as Class I devices are considered lower-risk and do not require pre-market approval. However, manufacturers must still comply with Health Canada's regulations for medical devices. Here's a step-by-step guide on how to apply:

Step-by-Step Process for Class I IVD MDL Registration in Canada

1. Confirm Your Device Classification

• Ensure your device qualifies as a Class I in vitro diagnostic device under the Medical Devices Regulations (SOR/98-282).
  • Class I devices are typically low-risk devices and may include simple diagnostic tests, in vitro reagents, and basic laboratory equipment.
• IVD classification: Confirm that your device meets the definition of an IVD device, which is a device intended for diagnostic use in the laboratory or other clinical settings (e.g., reagents, test kits).

2. Appoint a Canadian Authorized Representative (if applicable)

• If you are a foreign manufacturer, you must appoint a Canadian Authorized Representative (CAR) to act as a liaison between your company and Health Canada.
  • The CAR will handle regulatory submissions and communications with Health Canada on your behalf.
• Canadian-based manufacturers do not need a CAR and can apply directly.

3. Prepare Required Documentation

You will need to submit the following documentation for your MDL application:

• Device Description: Include a detailed description of the device, such as its intended use, technological characteristics, and any accessories.
• Labeling:
  • Bilingual labeling: All device labeling must be in both English and French, including packaging and instructions for use (IFU).
  • Compliance: Labels must also include relevant safety information, contraindications, and proper use instructions.
• Instructions for Use (IFU): Provide a copy of the IFU in both English and French.
• Quality Management System (QMS): Although ISO 13485 certification is not required for Class I devices, you should ensure that your device complies with good manufacturing practices.
• Certificate of Free Sale (optional): If the device is already marketed in other jurisdictions (e.g., US, EU), you may need to provide a Certificate of Free Sale to demonstrate its compliance in those markets.

4. Create an Account on Health Canada's Medical Device Establishment (MDE) Online Portal

• To submit your application, you must access the MDE Online Portal, Health Canada's official platform for medical device submissions.
• Create an account on the portal, which will allow you to submit your application, track its progress, and communicate with Health Canada.
  • Link: MDE Online Portal

5. Submit the MDL Application

• Complete the MDL Application Form: The application form requires detailed information about the device, manufacturer, and its intended use.
• Upload Documents: Attach all required documents (e.g., device description, labeling, instructions for use, quality management system details).
• Payment: Pay the application fee via the online portal at the time of submission. The fee can vary and is generally updated yearly by Health Canada.

6. Health Canada Review

• Once you submit the application, Health Canada will conduct a review of your documentation to ensure compliance with Canadian regulations.
• Health Canada will check for:
  • Completeness of documents
  • Proper classification of the device
  • Compliance with labeling and quality system standards
  • Adequate safety and usage information on the labels and packaging
• For Class I devices, this review typically takes 1 to 2 weeks if the application is complete and there are no issues.

7. Issuance of the Medical Device License (MDL)

• If your application meets all the requirements, Health Canada will issue the Medical Device License (MDL).
• The MDL allows you to legally market and sell the device in Canada.
• The MDL is valid for one year, after which you will need to submit a renewal application and pay the renewal fee.

8. Post-Market Compliance

• Ongoing Obligations:
  • You must comply with post-market surveillance requirements, including reporting adverse events or safety concerns related to the device.
  • Health Canada may request periodic updates to your device documentation.
  • Annual Renewal: The MDL must be renewed annually by submitting a renewal application and paying the required fee.

Summary of the Process:

1. Confirm device classification: Ensure the device is correctly classified as Class I.
2. Appoint a Canadian Authorized Representative (if applicable).
3. Prepare the required documentation: Include device description, labeling, IFU, and QMS (if applicable).
4. Create an account on the MDE Online Portal.
5. Submit the MDL application: Complete the form, upload documentation, and pay the application fee.
6. Health Canada review: Health Canada reviews the application.
7. MDL issuance: Receive the Medical Device License if the application is approved.
8. Post-market compliance: Ensure ongoing compliance, including renewal and adverse event reporting.

Contact Us：

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