I am not aware of any English language guidance document for Japanese classification of medical device, available free of charge. As much as I could find, the corresponding official document is only available in Japanese as well.
Does anyone happen to have an English version of Japan's Implementation of Specially Controlled Medical Devices, Controlled Medical Devices, and General Medical Devices Designated by the Minister of Health, Labour and Welfare Pursuant to Article 2, Paragraphs 5 through 7 of the Law (Ministerial Notification) from 2004, i.e. the "Classification Notification"?
I am new in the forum. Thus it looks like I cannot publish links yet. Anyway, a Ph.D. from PMDA gave the following talk on Understanding Japanese Medical Device Requirements in 2011 which has been published by PMDA: (sorry, I cannot publish it - URL on request). (It may not be that helpful any more as it was hold before the new PMDL was introduced in 2014.)
Furthermore, I found some useful information under (sorry, I cannot publish it - URL on request). But I could not find an English version of the Japanese Medical Device classifications. Does anybody know whether something like this has been published?
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