Japan QMS Ordinance No. 169 versus ISO 13485: Closing the Gap

1. Key takeaways

The Japanese QMS ordinance, MHLW Ordinance No. 169 of 2004, is structured in two major parts. Chapter 2 is integrated with the clauses of ISO 13485, while Chapter 3 and the chapters that follow contain the additional requirements specific to Japan. Holding an ISO 13485 certificate covers the first part; the second part, the Japanese additional requirements, is where the real gap lies. GRZAN recommends running the gap analysis in a chapter-three-first order, so that the Japan-specific obligations are addressed before the clause-level alignment with the international standard is revisited.

• Chapter 2 of the QMS ordinance corresponds to ISO 13485; Chapter 3 onward adds requirements aimed at securing the quality of medical devices in Japan.
• The ordinance is MHLW Ordinance No. 169 of 2004, published on December 17, 2004, and was finally amended by MHLW Ordinance No. 87 of 2014, published on July 30, 2014, in step with the enforcement of the PMD Act.
• The amendment aligning Chapter 2 with ISO 13485:2016 dates from March 26, 2021, in the Reiwa 3 revision.
• Suitable implementation of manufacturing management and quality management is a condition of approval under Article 23-2-5, paragraph 2 of the PMD Act.
• Typical gaps for overseas manufacturers sit at the interface with the licensed entity: information flow, Japanese-language records and reporting routes.
• An ISO 13485 certificate attests to the internationally aligned part of the ordinance, not to the Japanese additions.
• Building the interface with the licensed entity is where most of the practical remediation effort for Japan is concentrated.

2. Legal basis

The ordinance on standards for manufacturing control and quality control of medical devices and in vitro diagnostics, the QMS ordinance, is MHLW Ordinance No. 169 of 2004, published on December 17, 2004. It is the instrument that defines what a manufacturing site serving the Japanese market must implement, regardless of where the site is located.

Within the ordinance, Chapter 2 contains the provisions integrated with the clauses of ISO 13485, while Chapter 3 and the subsequent chapters contain the additional requirement items established for the purpose of securing the quality of medical devices and other products in Japan. The final amendment before the 2021 alignment is MHLW Ordinance No. 87 of 2014, published on July 30, 2014, synchronised with the enforcement of the PMD Act.

The amendment integrating ISO 13485:2016 is the revision dated March 26, 2021 in the Reiwa 3 era. The amendment date should be finally confirmed in the amendment history column of the e-Gov Legislative Search service, since ordinal references can shift with later consolidations.

Article 23-2-5, paragraph 2 of the PMD Act makes the suitable implementation of manufacturing management and quality management a condition of approval. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: the chapter structure of the ordinance itself explains why ISO 13485 alone is not enough for Japan. Chapter 2 maps to the international standard; Chapter 3 and beyond carry the Japanese additions. On the documentation of an overseas manufacturer this structure shows up in a characteristic way: the quality manual and the procedure documents are broadly usable, but the records and processes addressing Japan-specific obligations are missing. Examples include the information linkage with the marketing authorisation holder, the keeping of records in Japanese, and the reporting route towards the licensed entity. An ISO 13485 certificate attests to the first half of the ordinance, not to the second.

Insight 2: the 2021 amendment aligned Chapter 2 with ISO 13485:2016. The QMS ordinance was originally built around ISO 13485:2003, and the Reiwa 3 revision of 2021 brought Chapter 2 into line with ISO 13485:2016. Companies whose system documentation is still organised on the 2003 version need to redo the clause cross-reference. Clause numbering, structure and emphasis changed between the two editions, so an old cross-reference table can quietly mislead the gap analysis even where the underlying processes are sound.

Insight 3: closing the gap centres on the interface with the licensed entity. The Japanese additional requirements revolve to a large extent around the division of duties, the transmission of information and the retention of records between the marketing authorisation holder and the manufacturer. Documentation that is internally consistent within one factory usually lacks precisely these interface processes with the Japanese licensed entity. Building those interface documents is therefore where most of the practical remediation effort for the Japanese market is concentrated, and it is also the part of the work that an internal audit scoped to ISO 13485 alone will never surface.

4. Practical recommendations

• Start the gap analysis from Chapter 3. Close the Japanese additional requirements first, then return to the clause alignment of Chapter 2.
• Redo the clause cross-reference table against ISO 13485:2016. If the system documentation still rests on the 2003 edition, update the mapping.
• Build interface process documents with the Japanese licensed entity, defining information linkage, reporting routes and record-keeping responsibilities.
• Bring Japanese-language records and their retention into the quality system, with language, retention period and retrievability defined in the documents.
• Confirm the current amendment date of the ordinance in the amendment history of e-Gov Legislative Search before finalising any compliance assessment.
• Scope the internal audit so that it covers the Japanese additional requirements, not only the ISO 13485 clauses.

5. Verification checklist

• □ Did the gap analysis start from Chapter 3, the Japanese additional requirements, rather than from a bare ISO 13485 comparison?
• □ Has the clause cross-reference table been updated to ISO 13485:2016, referencing the March 26, 2021 revision?
• □ Have interface process documents with the Japanese licensed entity been established?
• □ Are the retention period and retrievability of Japanese-language records defined within the system?
• □ Has the amendment date of the ordinance been finally confirmed in the amendment history of e-Gov Legislative Search?

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team coordinates In-Country Representative arrangements, marketing authorisation holder duties, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com