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:
Appoint a Marketing Authorization Holder (MAH): Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) based in Japan. The MAH acts as the liaison between the manufacturer and Japanese regulatory authorities, managing the registration process and ensuring compliance with local regulations.
Submit Required Documentation:
Application Form: Manufacturers must complete the application form provided by the PMDA.
Company Information: Provide detailed information about the manufacturing facility, including its location and operations.
Quality Management System (QMS) Documentation: Submit documentation proving compliance with Japan’s QMS requirements, particularly MHLW Ordinance No. 169.
Device Information: Include detailed information about the medical device, including its design, manufacturing process, and intended use.
Inspection and Review: The PMDA or an accredited organization may conduct an inspection of the manufacturing facility to verify compliance with Japanese standards. This inspection ensures that the manufacturing processes meet required quality and safety standards.
Compliance Review: The PMDA’s Office of Compliance and Standards reviews the application and any responses to inquiries.
Final Review: The PMDA’s Office of Review and Administration completes the final review and issues the FMR certificate.
Obtain FMR Certificate: Once the review and inspection are complete, and all requirements are met, the PMDA issues the FMR certificate. This certificate is necessary for the subsequent registration of medical devices under various pathways like Shonin, Ninsho, or Todokede.
PMDA Foreign Manufacturer Registration (FMR) Expiry and Renewal
FMR itself does not have an expiration date. However, manufacturers must keep their Quality Management System (QMS) certificates up to date, renewing them every five years. To avoid any disruption in market access, the Ministry of Health, Labour, and Welfare (MHLW) recommends initiating the renewal process at least five months before the certificate expires. Additionally, any changes in the manufacturing process or device design must be reported to the PMDA to ensure continued compliance.
How Artixio Can Help
Navigating the Foreign Manufacturer Registration (FMR) process can be complex and time-consuming. Artixio specializes in regulatory affairs and can assist with the entire FMR process, from appointing a qualified MAH to ensuring all documentation is in order and compliant with Japanese regulations. Our expertise ensures a smoother entry into the Japanese market, allowing you to focus on your core business operations.
Contact Us Today: For expert guidance and support with your Foreign Manufacturer Registration in Japan, reach out to Artixio at info@artixio.com. Let us help you achieve regulatory compliance and access the lucrative Japanese medical device market.
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