Medical Devices

We assist clients in the classification and registration of medical devices based on the Medical Device Regulations of Canada.

Health Canada defines "medical device" as an article, instrument, apparatus or contrivance, including a component, part or accessory of one, that is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being.

All the medical devices are classified into four main categories with Class I representing the lowest risk and Class IV the highest:
  • Class I
  • Class II
  • Class III
  • Class IV
The classification of the medical device is carried out on a rule-based system.

The prime objective of Health Canada is to ensure that all the medical devices are safe, effective and meet the quality standard and thus ensuring the proper functionality. The Medical Devices Regulations also require that medical devices are manufactured under a quality standard (specifically ISO Standard 13488:2003).

MCS Associates Inc. performs medical device classification and registration of Class II, Class III and Class IV with Health Canada.

Our Quality Consultation Division ensures that the firm has a valid Establishment License and also prepares the required documents including the standard operating procedures for the activities such as recall, distribution records, mandatory problem reporting, complaint handling and corrective/preventative actions etc.

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Class I devices do not require a medical device license; however, manufacturers, distributors and importers of Class I devices are required to obtain an establishment license.

Health Canada only accepts quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.

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