Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs?

bill.Kal

Involved In Discussions
hi community!

We have just received a a CE-mark under EU-MDR and I am trying to understand if I can use conformity with applicable GSPRs under MDR and the MDR-compliant Technical File to submit to Japan.
This is a class IIa device and given that Japan is part of MDSAP, I think it may possible but can someone confirm or provide an English document that discusses the alignment of Japanese regulations with EU-MDR?

As always in debt of gratitude for this community!
 
Top Bottom