It is a separate process from the product registration process, and is required for obtaining product registration approval.
The audits are typically carried out via documentary inspections, although there have been a few on-site inspections in the past. Facilities that are responsible for manufacturing are assessed in order to confirm that the foreign manufacturer is able to participate in the product registration process. For medical devices, the following sites are required to be registered for each product:.
Applicants must submit personnel information for the manufacturing facilities to obtain FMR approval. Applicants must submit personnel information for the manufacturing facilities to clarify potential reasons for disqualification, such as health issues, criminal records, and revocation of previous registrations. The required materials include:. If the PMDA requires a rare on-site inspection, only then will applicants need to submit manufacturing facility information like floor plans and production process flowcharts.
The major change from the license and accreditation process to the registration process is that Buildings and Facilities Regulation BFR compliance is no longer a prerequisite for the application. This means that applicants no longer need to submit manufacturing facility information such as floor plans and production process flowcharts for the FMR application, unless the PMDA determines that a rare on-site inspection is necessary.
With the FMR system, only the design facility, main assembling plant, sterilizer site for sterile medical device products , and domestic distribution center need to be registered. What occurs during the Foreign Manufacturer Registration process? For medical devices, the following sites are required to be registered for each product: Design facility — the facility that maintains the design and development records for the product; the person responsible for the manufacturing operations should work here Main assembling plant — the facility that implements assembling filling processes; this facility is primarily responsible for Quality Management System QMS compliance or product realization Sterilizer — the facility that implements the sterilization process for sterile medical device products Domestic distribution center in Japan — the facility that stores the product and manages the final release of the product to the Japanese market Applicants must submit personnel information for the manufacturing facilities to obtain FMR approval.
What documents and materials are required for Foreign Manufacturer Registration? The required materials include: Application for registration Form Document stating applicant is not intoxicated or under the influence of illegal substances Curriculum vitae of the representative of the facility to be registered Drawings or maps of facility premises or areas If the PMDA requires a rare on-site inspection, only then will applicants need to submit manufacturing facility information like floor plans and production process flowcharts.
What is the difference between the Foreign Manufacturer Registration requirements and the previous Foreign Manufacturer Accreditation requirements? Pacific Bridge Medical can act as your FMR representative and assist you with the registration process to prepare your manufacturing facilities for the FMR audit. We will obtain manufacturing and product registration approval on your behalf efficiently so that your business can succeed in Japan. Contact us today for a free consultation with Japan foreign manufacturer registration experts.