P
Paperman
Question 1:
Our company designs and manufactures reagents and software for tissue typing. I am investigating the requirements to distribute these products in Japan as in-vitro diagnostic (IVD) for diagnostic purposes.
According to information the medical device regulatory approval process starts with: "Determine classification of your device according to the Japanese Pharmaceutical Affairs Law (PAL)and Japanese Medical Device Nomenclature (JMDN) codes."
So far I have not been able to find current English versions of the PAL, and three appendices with JMDN codes I found through Elsmar Cove posted link [https://www.std.pmda.go.jp/stdDB/index_e.html] only mention equipment, not IVDs.
Current situation is that I don't know which procedure to follow, class I, II, III or IV.
Isn't there more straight forward Japanese regulatory documentation like the European IVD-directive or the Canadian MDR?
Question 2:
Our Japanes distributor claims that it is permitted to sell CE-IVD products not registered in Japan as RUO in Japan. Is this true? It seems unlikely to me after all the label carries the IVD symbol as specified in (EN)-ISO 15223-1:2012,IDT.
Thank you in advance for your assistance.
Our company designs and manufactures reagents and software for tissue typing. I am investigating the requirements to distribute these products in Japan as in-vitro diagnostic (IVD) for diagnostic purposes.
According to information the medical device regulatory approval process starts with: "Determine classification of your device according to the Japanese Pharmaceutical Affairs Law (PAL)and Japanese Medical Device Nomenclature (JMDN) codes."
So far I have not been able to find current English versions of the PAL, and three appendices with JMDN codes I found through Elsmar Cove posted link [https://www.std.pmda.go.jp/stdDB/index_e.html] only mention equipment, not IVDs.
Current situation is that I don't know which procedure to follow, class I, II, III or IV.
Isn't there more straight forward Japanese regulatory documentation like the European IVD-directive or the Canadian MDR?
Question 2:
Our Japanes distributor claims that it is permitted to sell CE-IVD products not registered in Japan as RUO in Japan. Is this true? It seems unlikely to me after all the label carries the IVD symbol as specified in (EN)-ISO 15223-1:2012,IDT.
Thank you in advance for your assistance.