In Canada, the application for Class I in vitro diagnostic (IVD) medical device registration (via a Medical Device Establishment License (MDEL)) should be submitted to Health Canada, the federal department responsible for the regulation of medical devices.

Where to Apply:

• Health Canada's Medical Devices Directorate (MDD) is the division that manages the approval and regulatory activities related to medical devices.
• The specific platform for applying for an MDEL and registering a Class I IVD device is the Medical Device Licensing System (MDLS), which is part of the Health Canada's Electronic Submission System (ESS).

Steps to Submit the Application:

1. Create an Account:

   • To submit your MDEL application online, you must first create an account in the Electronic Submission System (ESS) via the Health Canada website.

2. Submit the MDEL Application:

   • Once you have an account, you can submit the application for an MDEL using the Medical Device Licensing System (MDLS). You’ll need to provide the required documentation and information about your device, including labeling, risk management, and proof of compliance with Health Canada's Medical Device Regulations (MDR).

3. Online Submission:

   • The application for the MDEL is completed online through the Health Canada Medical Device Licensing System. Instructions and required forms are available on the Health Canada website.

Health Canada Contact Information:

• Website: Health Canada - Medical Device Regulations
• Phone: For inquiries related to the Medical Device Establishment License (MDEL) and IVD device registration, you can contact Health Canada’s Medical Device Directorate directly. Contact details are available on the Health Canada website.
• Email: You may also reach out to Health Canada via their online contact forms for medical device-related questions.

Health Canada Medical Device Licensing System (MDLS) Portal:

• Health Canada - Medical Device Licensing System

By following the steps outlined above and submitting through the proper channels, you will be able to apply for and obtain an MDEL to legally distribute your Class I IVD medical device in Canada.