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Hello Everyone. I have a question. Do Canadian Medical Device Regulations follow the same rules and regulations as Europe when it comes to classification of Medical Devices? Thanks in advance.
< 1 min reading time
As originally asked by Yasser Mohammad.
With that said, the risk classes are also different. In the EU, they are I, IIa, IIb, and III. In Canada, they are I, II, III, and IV.
For IVDs, the rules are not similar between the two regulatory jurisdictions.
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