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Medical Device Regulations in Canada


In Canada, the Medical Devices Directorate (MDD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices.

Medical Device

The term "medical device" covers a wide range of medical instruments used to treat, reduce, diagnose or prevent a disease or abnormal physical condition. Some examples include: hip implants, pacemakers. synthetic skin. artificial heart valves, test kits for diagnosis. medical laboratory diagnostic instruments etc

Classification of Medical Device

Class I - Low Risk

Class II - Low-Moderate Risk

Class III - High-Moderate Risk

Class IV - High Risk

Registration Types

There are 2 types of licenses issued by Health Canada:

1. MDEL (Medical Device Establishment License) – Class I Devices

2. MDL (Medical Device License) – Class II, Class III and Class IV Devices

Registration Timeline

  • Class I: 1-2 months or less
  • Class II licence applications: 15 calendar days
  • Class III licence applications: 75 calendar days
  • Class IV licence applications: 90 calendar days

Note: Every manufacturer should be ISO 13485:2016 compliance as Medical Device Single Audit Program (MDSAP).

Steps in Registration

1. Classify your Medical Device

2. All the devices must comply with all guidelines of ISO:13485 certification as MDSAP except Class I.

3. Class I Medical Devices should get MDEL certification and Class II, III, and IV devices should get MDL certification. 

4. Submit the fees and documents as per your device requirement

For Class I Medical Device, submit and pay the health Canada fees

For Class II devices, submit an MDL application, Fees, labeling, Conformity declaration, MDSAP cert and other major required documents

5. Health Canada reviews the application and notifies you on the approval.

Note: No authorized representative is required in Canada and languages required are french & english.

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