Japan Ordinance 169 QMS Compliance

PMD Act and Ordinance 169

The regulation of medical devices in Japan is governed by the Pharmaceuticals and Medical Devices Act (PMD Act), which was established by the Ministry of Health, Labour, and Welfare (MHLW) to ensure the quality, efficacy, and safety of medical products. Under this act, MHLW Ministerial Ordinance #169 defines the specific quality management system (QMS) requirements that manufacturers must satisfy to sell their devices in the Japanese market. This ordinance applies to both domestic and foreign manufacturers, creating a standardized legal environment for all market participants.

While Ordinance 169 has been largely harmonized with the international standard ISO 13485:2016, it is not an identical adoption. Japan has incorporated additional requirements that manufacturers must address to achieve full compliance. Therefore, holding an ISO 13485 certificate is a significant advantage but does not automatically grant proof of compliance with Japanese law. Manufacturers must carefully manage the gaps between international standards and local ministerial mandates to ensure successful market entry.

Relationship between Ordinance 169 and ISO 13485

The alignment of Ordinance 169 with ISO 13485:2016 has made the compliance process more straightforward for global manufacturers. However, full adherence to Japanese regulations requires attention to specific domestic deviations.

Integration of Additional QMS Requirements

Ordinance 169 contains unique provisions regarding record retention periods, documentation of manufacturing processes, and specific requirements related to the Marketing Authorization Holder (MAH). Manufacturers must also ensure that their quality manuals reflect the nuances of the Japanese regulatory system, particularly concerning how they interact with their Japanese partners, such as the Designated Marketing Authorization Holder (D-MAH).

The Importance of the Device Master File

A key distinction between ISO 13485 and Ordinance 169 is the requirement for a Japanese Medical Device Master File (Seihin Hyojun Sho). This document is similar to a European Technical File and defines critical product specifications, including information on storage, labeling, packaging, and testing. The Pharmaceuticals and Medical Devices Agency (PMDA) and Registered Certification Bodies (RCB) are extremely meticulous regarding the content of this file. Any inconsistencies between the Device Master File and the primary application files can lead to significant delays in the approval process.

QMS Conformity Investigations and Certification

Under the PMD Act, manufacturing facilities must undergo a QMS conformity investigation as part of the initial registration and subsequent maintenance phases.

Audit Procedures by PMDA and RCB

Conformity assessments are typically conducted by either the PMDA or an RCB, depending on the classification of the device. For foreign manufacturers, these investigations often involve their license holders in Japan. While on-site audits are common for biological or remanufactured devices, many manufacturers with existing ISO 13485 or MDSAP certification may be eligible for a desktop audit. The successful completion of this investigation results in the issuance of a Certificate of QMS Conformance, known locally as Kijun Tekigoshou.

Validity and Maintenance of Conformance

The Certificate of QMS Conformance is valid for a period of five years and is tied to specific product groups rather than just the manufacturing facility. While device registrations in Japan do not expire, the manufacturer is legally required to renew and maintain their QMS Conformance certificate every five years to continue marketing and commercial distribution. This renewal process ensures that the quality system remains robust and aligned with evolving Japanese safety standards.

Proregulations' Japan QMS Compliance Services

Our standardized service process facilitates the efficient navigation of Ordinance 169 and the PMD Act to ensure your quality system meets the rigorous expectations of Japanese regulators:

• Quality manual review and gap analysis against Ordinance 169
• Preparation and optimization of the Japanese Device Master File
• Support for MDSAP transition and Japanese market integration
• Drafting of supplemental documents and quality manual appendices
• Mock audits to prepare for PMDA or RCB conformity assessments
• Management of the QMS conformity assessment application process

If you are interested in our Japan QMS compliance services and wish to secure your market position through robust Ordinance 169 alignment, please feel free to contact us.