Japan's medical device market, one of the largest and most competitive globally, presents significant opportunities for international manufacturers. However, to access this market, foreign manufacturers must navigate complex regulatory requirements, including obtaining Foreign Manufacturer Registration (FMR). This blog explores the FMR process, its requirements, and how it fits into the broader framework of medical device regulation in Japan.
What is PMDA Foreign Manufacturer Registration (FMR) in Japan ?
Foreign Manufacturer Registration (FMR) is a mandatory process for manufacturers outside Japan who wish to market their medical devices within the country. The FMR ensures that all non-Japanese manufacturers comply with Japanese regulations and quality standards before their products can be sold in Japan. Previously known as Foreign Manufacturer Accreditation (FMA) or Accreditation of Foreign Manufacturers (AFM), Foreign Manufacturer Registration (FMR) is mandated by Japan’s Pharmaceuticals and Medical Devices Act (PMD Act). It is a crucial step in the broader regulatory process overseen by the Pharmaceuticals and Medical Devices Agency (PMDA).
Why is Foreign Manufacturer Registration (FMR) important ?
Regulatory Compliance: FMR confirms that foreign manufacturers adhere to Japanese regulatory standards and allows their devices to be approved for sale in Japan.
Market Access: Without FMR, foreign manufacturers cannot distribute their products in Japan, making it essential for market entry.
Quality Assurance: It ensures that manufacturing practices meet Japanese quality standards, safeguarding patient safety.
Facilities Requiring PMDA Foreign Manufacturer Registration (FMR) in Japan
The following facilities must be registered for each medical device product:
Design Facility: Where product development occurs and records are maintained.
Main Assembling Plant: Responsible for assembly and ensuring adherence to QMS requirements.
Sterilizer: Where the sterilization process is conducted for sterile medical devices.
Domestic Distribution Center: Manages final product distribution and storage in Japan.
All documents must be provided in Japanese to comply with local regulations.
Key Requirements for PMDA Foreign Manufacturer Registration (FMR) in Japan
Documentation in Japanese: All submitted documents must be in Japanese, or accompanied by a certified translation.
QMS Compliance: Adherence to Japanese Quality Management System standards is mandatory.
Designated Local Representative: The MAH or a Designated Marketing Authorization Holder (DMAH) must be appointed in Japan.
Foreign Manufacturer Registration (FMR) Application Process in Japan
The process of obtaining FMR involves several key steps: