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Foreign Manufacturer Registration（FMR）
Under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), foreign companies manufacturing drugs, quasi-drugs, APIs, or medical devices overseas and importing them into Japan must register with the Ministry of Health, Labor and Welfare (MHLW). This process, called “Toroku” or Foreign Manufacturer Registration (FMR), is separate from product registration and is required to obtain product approval. It replaced the former Foreign Manufacturer Accreditation (FMA) system in 2014.
What happens during FMR?
FMR involves an audit by the Pharmaceuticals and Medical Devices Agency (PMDA), typically conducted through documentary inspections. The process evaluates whether the manufacturer is eligible to join the product registration process. For medical devices, the following facilities must be registered:
Design facility (maintains design/development records)
Main assembling plant (handles assembly and QMS compliance)
Sterilizer (for sterile products)
Domestic distribution center (stores and releases products in Japan)
Personnel details of each facility must be submitted. Once approved, the FMR certificate is issued to the manufacturer’s Marketing Authorization Holder (MAH) by the PMDA.
Required documents for FMR
Applicants must provide information to identify any potential disqualifications such as health or legal issues. Key documents include:
Application form (Form 63-5)
Statement of sobriety
CV of the facility’s representative
Facility layout or map
Detailed manufacturing info (like floor plans) is only required if the PMDA requests an on-site inspection.
What changed from FMA to FMR?
With the shift from FMA to FMR in 2014, compliance with Building and Facilities Regulations is no longer required for most applications. Manufacturing layouts and process charts are typically not needed unless an inspection is triggered. Also, fewer facility types are required to register under FMR than under the previous system.
Sakura Trading Corporation regulatory team can serve as your FMR representative and guide you through the process. With 30 years of experience in Japanese regulatory affairs, we ensure your facility and product meet all requirements efficiently. Contact us for a free consultation.
Distributor Search
Let Sakura Trading help you find the right distributor for your medical device in Japan.
Entering the Japanese medical device market requires trusted, well-connected local partners. Finding a capable distributor, however, can be time-consuming and complex due to Japan’s regulatory, cultural, and language-specific challenges.
Key Considerations:
Relationship Building: Japanese distributors value trust and prefer face-to-face meetings before signing agreements.
MAH/DMAH Requirements: Foreign companies must appoint a Marketing Authorization Holder (MAH) to import and sell devices in Japan. While some choose a distributor as their MAH, this can create risks in confidentiality and control. A third-party MAH like Sakura Trading helps you maintain independence and flexibility.
Expertise & Network: Not all distributors specialize in your device category. Selecting one with relevant clinical connections and product knowledge is essential.
Market Access & Language: Strong market presence and Japanese language support are critical for successful sales and communication.
Our Process:
Local Research: Our Tokyo-based team identifies and evaluates potential distributors using local insights.
Engagement: We introduce your product and assess interest, innovation fit, and competitive positioning.
Proposal Review: We analyze sales strategies and projections from interested distributors.
Final Selection & Support: We help you select the most suitable partner, negotiate terms, and manage performance locally.
Sakura Trading Corporation brings decades of experience in Japan’s medical device market. Contact us today to find your ideal distributor.
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