Does anybody know about the additional test requiremnt for the registration of medical device in Japan?
I know that there is some additional test or a kind of modification method to conduct biocompatibility testing for medical device .
Thanks
You are correct.
The current Japanese guidance document - “Test Methods for Biological Safety Evaluation of Medical Devices, Assessment of Medical Device, Notice 36” only partially the same as ISO 10993. It also has technical specifications to perform tests that different from ISO 10993.
Therefore, some regulators in Japan do not readily accept testing to ISO 10993 and asking to perform an additional testing for product to get approval.
You should contact a CRO that specializes in biocompatibility testing and performs these tests. This way you will get an idea of how to move forawrd in the best possible way in addition to ISO 10993. Also please check JIS (Japanese industrial standards) for any new guidance for your type of product.
I hope this helps,
Mike
