Foreign Manufacturer Registration in Japan for Medical Device Companies

ANSWERED ON THIS PAGE:

• What are the manufacturer registration requirements in Japan?
• What is the process for registering my manufacturing establishments?
• How long is my FMR registration valid?

Japan's Pharmaceuticals and Medical Devices Act (PMD Act) requires both domestic and foreign companies to register applicable manufacturing facilities. This is a different process than device registration. You can read about that here.

The previous regulation - the Pharmaceutical Affairs Law (PAL) - referred to this as a Foreign Manufacturer Accreditation. The new system, called Foreign Manufacturer Registration (Toroku), requires the following:

• Foreign manufacturers must register their manufacturing facilities with the Ministry of Health, Labour, and Welfare (MHLW) via the Pharmaceuticals and Medical Devices Agency (PMDA).
• Japanese manufacturers must register any of their domestic manufacturing facilities with their local prefectural authorities.

Preparing the Foreign Manufacturer Registration (FMR) application

The following documents must be prepared for the application and submitted to the PMDA. Emergo can assist in compiling and coordinating these documents for you:

• Application for medical device Foreign Manufacturer Registration
• Business Number Registration Form to obtain a business number and its serial code (Gyosha) for each manufacturing establishment.
• Supporting documentation such as:
  • self-Declaration of Medical Condition ("Someisho") of the senior manager representing manufacturer,
  • personal history of the responsible person of manufacturing facility to be registered,
  • pictures, drawings, floor plans, etc. showing the building(s) within the scope of registration.

Once you receive your FMR certificate, it remains valid for five years. The MHLW recommends beginning the renewal process at least five months in advance of your certificate's expiration date.

Let Emergo prepare your FMR application

The FMR application is usually submitted by your Marketing Authorization Holder (MAH)/Designated Marketing Authorization Holder (D-MAH). As Emergo Japan Consulting does not have an MAH license, we can prepare your application and provide it to a licensed MAH for the final payment and submission. Emergo can:

• Verify and compile all documentation required for the FMR application.
• Deliver finalized documentation to your MAH.
• Correspond with the MHLW regarding any follow-up requests.
• Assist with FMR amendment submissions and FMR renewal submission.
• Prepare your device registration submission.

Please contact us for more information about Foreign Manufacturer Registration certificates for medical device companies selling in Japan.