Frequently Asked Questions
How are devices classified in Japan?
Medical devices in Japan are classified using a coded predicate system combined with a rule-based risk assessment based on GHTF classification rules. Japan Medical Device Nomenclature (JMDN) codes identify the device classification and registration pathway. Devices are segmented into General Class I, Specified Controlled Class II, Controlled Class II, Specified Highly Controlled Class III, Highly Controlled Class III, or Highly Controlled Class IV.
How long does it take to register devices in Japan?
Timelines for medical device registration in Japan vary considerably depending on your device classification. Download our informative PDF chart (English) for details on the process and timelines.
Will our clinical studies and testing conducted outside Japan be accepted?
The PMDA often accepts the results of clinical trials conducted outside Japan if the investigation conforms to Japan's Good Clinical Practices. We can provide you with the support necessary to take a pre-submission consultation meeting with the PMDA to determine acceptability of the foreign clinical data. If the PMDA requires additional clinical investigations, Emergo can assist you with contracts, GCP documentation, clinical investigation document review, and more.
Can we "own" our Japanese device registration?
The MHLW permits manufacturers with no location in Japan to register their own Class II, III, and IV devices through the Foreign Special Approval System (FSAS). This registration route allows you to own your device registrations in your own name and take on some of the responsibilities of the Marketing Authorization Holder (MAH). However, because you have no Japanese office, you still need to appoint a licensed Designated Marketing Authorization Holder (D-MAH) in Japan that will coordinate shipment releases to your distributor and handle complaints and vigilance.
Manufacturing establishment registration for domestic manufacturers vs. foreign manufacturers
The PMD Act defined a new registration system for manufacturers. The registration system requires domestic manufacturers to register their manufacturing establishments with their local prefectural government and obtain Manufacturer Registration (MR). Foreign manufacturers, on the other hand, must register their manufacturing establishments with the PMDA and obtain a Foreign Manufacturer Registration (FMR) certificate. The MR and FMR is a requirement of the application of medical device registration and needs to be obtained prior to the filing.