Canadian Medical Device Regulations (CMDR) and the Food and Drug Act

Obtaining a Canadian Medical Device License, in addition to reflecting positively on your product line, is also the most affordable regulatory approval. Health Canada, as regulatory agencies go, is smaller then most however they are very influential on the world stage and highly respected. The Canadian Food and Drug Act, which also covers medical devices, stipulate requirements that are easily integrated into your quality and regulatory processes. For those reasons, Health Canada approval should be high on your list of priorities.

Canadian requirements are modeled on EU structure with some important differences. There are four risk classifications (I, II, III and IV). Class I devices do not require a license, all other classifications do. All manufacturers have to meet the requirements stipulated in the CMDR. Proper licensing is checked at border crossings where you risk product seizure or is a part of hospital/joint buying group competent bidding where you risk exclusion from the competition.

We know the process, the costs, what works, what does not work and how to effectively interact with testing laboratories, CMDCAS registrars and Health Canada officials. With Horizon Phoenix as your consulting partner you will quickly navigate through:

1. Self declaration of product conformity (if applicable)
2. Family or product grouping that saves time and money
3. Conformity assessment routes (including options, if applicable)
4. Safety and Effectiveness requirements
5. Using recognized standards to demonstrate conformance
6. Labels and instructions for use
7. Product testing
8. Assembly Technical (STED) Files
9. Risk Assessment and risk management
10. Declaration of Conformity
11. CAN/CSA/ISO 13485 quality management systems
12. Design Dossier reviews, and
13. Preparing for CMDCAS assessments.

Canada an important trading partner?

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Why Horizon Phoenix?

Our Senior Partner was Chairman of the Ad hoc Stakeholders committee assisting Health Canada develop the new regulations and moderated a series of North America-wide consultation seminars discussing the impact of the new regulations with more than 700 different stakeholders.