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Hi everyone!
I am new in this forum and I have a few questions for anyone who has experience with Japanese regulations for medical devices.
1. Are devices classified based on their quality systems only, following a CE mark approach, or do the claims of intented use affect the classification?
e.g. If the same device has intended use of adjunct to a standard diagnostic method will it be classified differently if the intended use is for an independent diagnostic device?
2. Would clinical trials in the EU (specifically UK and Greece) be accepted for review from the Japanese health system or would we need to conduct new ones there?
3. Is it true that for a class I the distributor and not the manufacturer needs an ISO 13485? What happens for class II?
Well these are my questions...Any help would be appreciated!
I am new in this forum and I have a few questions for anyone who has experience with Japanese regulations for medical devices.
1. Are devices classified based on their quality systems only, following a CE mark approach, or do the claims of intented use affect the classification?
e.g. If the same device has intended use of adjunct to a standard diagnostic method will it be classified differently if the intended use is for an independent diagnostic device?
2. Would clinical trials in the EU (specifically UK and Greece) be accepted for review from the Japanese health system or would we need to conduct new ones there?
3. Is it true that for a class I the distributor and not the manufacturer needs an ISO 13485? What happens for class II?
Well these are my questions...Any help would be appreciated!
