The Canadian Medical Device Regulations (CMDR) is the guidance that classifies medical devices in Canada.
Medical devices are classified according to the level of risk they pose for the user, be it the patient or the people employed in the healthcare industry. The global body that oversees this classification is The Global Harmonization Task Force (GHTF). This task force issues guidance documents that set out the risk classification of medical devices.
Risk categories according to the CMDR medical device classification
Accordingly, for the CMDR medical device classification, there are fourrisk categories of devices. These are Class I, ClassII, ClassIII, and ClassIV. CMDR medical device classification is a rule based system whose criteria are listed out in Schedule 1 of the CMDR.
Further, there are four classes of medical devices based on risk level: A, B, C and D. This rule based system is defined in this guidance document.
CMDR medical device classification: a summary
This is how the CMDR medical device classification can be explained in a nutshell:
- Medical devices are classified into four classes (I, II, III, and IV) according to the CMDR medical device classification
- Based on Schedule 1 Part 1, a rule based system; the manufacturer has to make this classification
- The criterion for this classification is the controls placed on them. There are different licensing requirements depending on the class of the device, that have to be implemented for each of these classes
- Under the CMDR medical device classification; there is no distinction between existing devices and new devices
- For a Class I medical device that is being sold directly without a Canadian intermediary; a Medical Device Establishment Licenses (MDEL)is necessary
- For all other classes of medical devices; the CMDR medical device classification requires implementation of ISO 13485:2003 quality system that is tailored to Canadian requirements.
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