Medical Device Consulting Services for Canada

Techlink International Consulting, LLC helps medical device manufacturers obtain regulatory approval from Health Canada. We assist clients with Canadian Medical Devices Regulations (CMDR) issues related to quality assurance, regulatory compliance and distribution management. Our consultants are also experienced in quality system audits and implementation and can help your company meet Health Canada MDR regulations.

Medical device manufacturers will likely need to secure a license in order to enter the Canadian Market. Health Canada issues two types of licenses: the Health Canada Medical Device Establishment License (MDEL) and the Health Canada Medical Device License (MDL).

Health Canada Medical Device Licenses Approvals and Registration

If you sell medical devices in Canada, you will likely need to secure a license. There are two licenses issued by Health Canada.

Health Canada Medical Device Establishment License (MDEL)

Class I medical device manufacturers must secure a Medical Device Establishment License (MDEL) if selling directly into Canada and not through a distributor. However, if you sell through distributors in Canada, then your distributor must have an MDEL. Distributors and importers of medical devices, regardless of the device classifications, must secure a MDEL. An MDEL is a permit for the company/distributor/importer itself.
An MDEL is not required for manufacturers of Class II, III and IV medical devices.

Health Canada Medical Device License (MDL)

A Canadian Medical Device License (MDL) is required for all manufacturers of Class II, III, and IV medical devices in Canada. The MDL is a product approval. Canada’s Medical Devices License (MDL) is comparable to the US FDA 510(k) process. The process of obtaining a MDL is usually faster than the FDA for Class II devices, about the same time for Class III devices and is more complicated for Class IV devices.

A Canadian Medical Device License requires manufactures to prove that they have been certified with the ISO 13485:2003 quality system certificate and meet the specific requirements of the Canadian Medical Device Regulations (CMDR). This is also known as the Canadian Medical Devices Conformity Assessment System (CMDCAS). Techlink International Consulting, LLC can assist in ensuring you are compliant.

The below demonstrates the steps in the Health Canada approval process.

Step 1
Determine the classification of your medical device according to Schedule 1 of the Canadian Medical Devices Regulations (CDMR). All devices will fall into Class I, Class II, Class III or Class IV designations.

Step 2
Health Canada mandates that for all devices (except class I devices) the manufacturer implements ISO 13485:2003 which includes additional specific requirements of the CMDR, that are not required of companies currently selling in the European market. The manufacturers must ensure they update their system incorporate the CMDR requirements.

Step 3
All devices (except Class I) must have the ISO 13485:2003 quality system (re)audited by a Registrar accredited by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). A new ISO 13485 certificate will be issued upon successful completion of the audit.

Step 4
For Class I devices:
A Medical Device Establishment License (MDEL) is only needed if you sell your device directly to the end user. For all other devices, a Canadian Medical Device License (MDL) application is needed for your device. Please note that an MDL application is for the device itself whereas an MDEL is a permit for the distributor/importer, or a manufacturer of Class I devices.

Step 5
For Class I devices:
One needs to submit a MDEL application (if selling directly into Canada or needs to ensure their distributor has a valid certificate) and pay for the Health Canada fees.

For Class II devices:
One needs to submit a MDL application, ISO 13485 certificate and pay for the Health Canada fees.

For Class III and IV devices:
One needs to submit MDL application, ISO 13485 certificate and Premarket Review Document following the Summary Technical Document (STED) (which may include clinical data) and pay the applicable Health Canada Fees.

Step 6
For Class IV devices, Health Canada will review your MDL application and Premarket Review Document. They will then issue a final decision.

Step 7
All approved applications will be posted on the Health Canada website.

Step 8
You will now be allowed to sell your medical device in Canada. Licenses do not expire but you must pay annual fees to Health Canada. Failure to pay fees will result in your approval license being revoked.

Techlink International Consulting, LLC can complete the Health Canada MDL and MDEL so that you can start selling your devices on the Canadian market. We can help you with:

• Device Classification
• Determining the proper annual license fee
• Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment Licence (MDEL) application.
• Develop, implement or modify your ISO 13485:2003 quality management
• Provide onsite employee training on ISO 13485:2003 and CMDR.
• Provide onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.