Medical Device Classification and Submission

Q&R Canada Inc. performs medical device classification and registration of Class II, Class III and Class IV with Health Canada.

All the medical devices are classified into four main categories:

  • Class I
  • Class II
  • Class III
  • Class IV

Class I represents the lowest risk and Class IV the highest. The classification of the medical device is based on the application of the risk classification rules outlined in the Medical Device Regulations.

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.

All risk II, III, and IV medical devices must be registered with Health Canada prior to their sale in Canada. Q&R 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 mandatory problem reporting, complaint handling, recall, distribution records, and corrective/preventative actions etc.

The Medical Device regulations require Class II, III and IV medical devices to be manufactured (Class II) or designed and manufactured (Class III and IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class 1 medical devices.

Q&R Canada, Canada Compliance, Product regulatory, Health Canada, Medical equipment

Our team at Q&R will handle the medical device submission preparation and on-going contact with the Medical Devices Bureau. We can also handle any review of product labels to ensure compliance with Canadian labelling regulations.

Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.