The Global Harmonization Task Force (GHTF) is deemed with the task of issuing guidance documents on medical device risk classification. Its classification is made based on the risk level the medical device poses. The US, Canada and the EU are covered in the Task Force’s guidance.
The guidance that deals with medical device risk classification in Canada is the Canadian Medical Device Regulations (CMDR). The CMDR classification classifies devices into four risk categories (I, II, III, and IV). The basis for CMDR classification is a rule based system enunciated in Schedule 1 of the CMDR.
The CMDR classifies medical devices into four classes: A, B, C, and D, which are based on risk level. The guidance documentdefines thisrule based system.
A summary of CMDR classification
This is the essence of CMDR classification ofmedical devices:
- CMDR classification classifies medical devices into four classes (I, II, III, and IV)
- This classification has to be determined by themanufacturer in accordance with a rule basedapproach set out in Schedule 1 Part 1
- The classification of these devices is determined by the controls placed upon them. These are implemented through different licensingrequirements, which vary according to the class of the device
- Another outstanding feature of the CMDR classification is that it makes no distinction between “existing” devicesand “new” devices, i.e., the classification rules are the same irrespective of whether the medical device is being introduced for the first time into the market or has been around for a decade
- A Medical Device Establishment Licenses (MDEL)is needed if a Class I medical device is being sold directly without a Canadian intermediary
- CMDR classification requires all other classes of medical devices to implement SO 13485:2003 quality system to meet Canadian requirements.
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