Foreign Manufacturer Registration in Japan: Scope, Sites and Five-Year Renewal

1. Key takeaways

Foreign Manufacturer Registration, or FMR, is granted per manufacturing site and per registered process. One factory corresponds to one registration, and the registration is valid for 5 years. The scope question is not how many plants a company operates, but where each of the four process categories involved in the device under Class II to IV sits: design, primary assembly and other principal manufacturing processes, sterilisation, and domestic storage of the final product. FMR scope determination as the first task on the critical path of a Japan project, because every downstream step, from the approval dossier to the QMS investigation, assumes a correctly drawn registration scope.

• FMR is granted by the Minister of Health, Labour and Welfare, with application documents submitted through the PMDA.
• Registrations are valid for 5 years under Article 23-2-4, paragraph 2 of the PMD Act.
• Registered processes differ by classification: Class II to IV cover four process categories, general devices exclude design, and devices supplied as programs cover design only.
• Sterilisation sites, including contracted sterilisation providers, and contract primary assembly sites may each require their own registration.
• Unregistered manufacturing sites are a statutory ground for refusing approval of the product.
• Industry practice suggests starting renewal about 5 months before expiry, as a practical estimate rather than a statutory figure.
• Because one factory corresponds to one registration, a multi-site manufacturing network produces a correspondingly larger registration map.

2. Legal basis

Article 23-2-4, paragraph 1 of the PMD Act establishes the Foreign Manufacturer Registration, implemented by the Minister of Health, Labour and Welfare, with the application documents submitted to the PMDA. Article 23-2-4, paragraph 2 sets the validity period of the registration at 5 years.

Article 114-8 of the Implementing Rules specifies the registered processes. For Class II to IV devices these are design, primary assembly and other principal manufacturing processes, sterilisation, and domestic storage of the final product. Reprocessing of single-use devices carries additional registered processes. General medical devices do not include design, and devices supplied in the form of a program are subject to registration in respect of design only.

Form 63-5 of the Implementing Rules is the application form for Foreign Manufacturer Registration for medical devices and in vitro diagnostics, and Form 63-7 is the application form for renewal of registration. Article 23-2-5, paragraph 2 of the PMD Act provides that the absence of registration of the relevant manufacturing site is a ground for refusing approval.

MHLW notifications from October 2014 and the associated question-and-answer notification explain how the attribution of each process is judged. The specific notification numbers and dates should be confirmed on the current pages of the MHLW website. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: the registered process list changes with the classification, and the three lists are not the same. Article 114-8 of the Implementing Rules gives a different list for each classification. Class II to IV devices cover the four process categories; general medical devices do not include design; program-based devices cover design only. FMR scope therefore cannot be drawn uniformly according to company habit. It must be determined case by case against the classification of each device, and a scope that was correct for one product may be wrong for the next one in the same portfolio.

Insight 2: the sterilisation contractor and the assembly contractor may each need their own registration. Any site that performs the sterilisation process on which the sterility of the finished product depends, including a contracted provider, must be registered as a sterilisation site. Similarly, a contract manufacturer that takes responsibility for product realisation in primary assembly may fall within the primary assembly site category. This makes FMR a supply chain management instrument rather than a single certificate: the registration map must follow the actual manufacturing network, and changes among suppliers change the registration picture.

Insight 3: the renewal rhythm needs forward planning, on a practical estimate basis. The registration is valid for 5 years under Article 23-2-4, paragraph 2. Industry practice suggests starting the renewal procedure roughly 5 months before expiry. This is a practical estimate, not a statutory figure. Because an expired registration directly affects the lawful supply of the products that rest on it, renewal management is a high-risk item that deserves a dedicated tracker rather than ad hoc handling. In practice the renewal clock runs independently for each site, so a portfolio that spans several factories produces several staggered renewal dates, and consolidating them into a single register is what keeps the picture manageable.

4. Practical recommendations

• Determine the registered processes case by case against the device classification, and document the result as a three-column table of process, site and responsibility as the basis of the registration scope.
• Write the FMR cooperation commitment into supplier qualification criteria, especially for sterilisation contractors and primary assembly contractors.
• Maintain a registration validity register with advance reminders set on the 5-year cycle, and reserve time for renewal processing.
• Treat factory relocation and major reconstruction as change triggers, since a change of manufacturing site can affect registered content and should be resolved in the registration before the product change is pursued.
• Re-run the scope determination whenever the manufacturing network or the device classification changes.
• Confirm the current notification numbers and dates on the MHLW website before applying the process attribution guidance.

5. Verification checklist

• □ Has the registered process list for the device been confirmed under Article 114-8 of the Implementing Rules?
• □ Has the three-column table of process, site and responsibility been produced?
• □ Are all relevant contractors, including sterilisation and primary assembly, covered in the registration plan?
• □ Does the registration validity register carry advance reminders on the 5-year cycle?
• □ Are factory relocation and major reconstruction captured as change triggers?

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team coordinates In-Country Representative arrangements, marketing authorisation holder duties, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com