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 (see the "Frequently asked questions" section below) 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.
Frequently Asked Questions about Foreign Manufacturer Registration in Japan
We have multiple manufacturing facilities. Do we need to register all of them?
Under the PMD Act, you are required to obtain registrations for the manufacturing sites that fall within the registration scope. Foreign-based manufacturers must register facilities responsible for product design and development, primary manufacturing, or sterilization. Relevant contract manufacturers must also be registered. Emergo can you assist you with identifying which sites require registration.
What is the self-declaration of medical condition (Someisho)?
A self-declaration of medical condition is required documentation for FMR application. The responsible person must submit a self-declaration that they are mentally competent and have no drug addictions.
Are the business number and its serial code needed before we submit our device registration?
The Foreign Manufacturer Registration is also required before you may submit your FMR, which precedes your device registration submission to the MHLW.
We lost our Foreign Manufacturer Registration Certificate. Do we need to re-submit the registration?
In the event of a lost FMR certificate, you must submit a letter to the MHLW explaining why and how it was lost or destroyed. The MHLW may re-issue an original certificate based on the content of your letter. Emergo can assist with certificate reissue requests to the MHLW. Please keep the original of the certificate in a safe place because you must return it to MHLW when submitting FMR renewal application.
Does our Foreign Manufacturer Registration need to be renewed?
Yes, your FMR must be renewed every 5 years. The MHLW recommends beginning the renewal process at least five months in advance of your certificate’s expiration date.