Foreign Manufacturing Establishment 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 FMER registration valid?

What is Japan’s pharmaceutical and medical device act (PMD Act)?

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.

Foreign Manufacturing Establishment Registration (Gaikokuseizogyosya 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 Manufacturing Establishment Registration (FMER) 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 Manufacturing Establishment 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 FMER 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 FMER application

The FMER 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 FMER application.
• Deliver finalized documentation to your MAH.
• Correspond with the MHLW regarding any follow-up requests.
• Assist with FMR change notifications and FMER renewal submissions application.

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

Frequently asked questions about Foreign Manufacturing Establishment 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 facilities that fall within the registration scope. Foreign-based manufacturers must register facilities responsible for product design and development, primary manufacturing, or sterilization. If your multiple facilities are located at different addresses and are responsible for the manufacturing activities within the scope, you must register each facility separately. Also, relevant contract manufacturers must also be registered. Emergo can 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 FMER 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 Manufacturing Establishment Registration is also required before you may submit your FMER, which precedes your device registration submission to the MHLW.

We lost our Foreign Manufacturing Establishment Registration Certificate. Do we need to re-submit the registration?
In the event of a lost FMER 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 certificate in a safe place because you must return it to MHLW when submitting the FMER renewal application.

Does our Foreign Manufacturing Establishment Registration need to be renewed?
Yes, your FMER 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.