Legal Hierarchy: Act, Cabinet Order, Ministerial Ordinance, Public Notice

1. Key takeaways

Japanese medical device regulation is structured in five layers: act, cabinet order, ministerial ordinance, public notice, and notification. The first three layers carry the force of legal sources; among the latter two, public notices carry the certification standards, while notifications carry the actual operative interpretations used in review and enforcement. The most common mistake Chinese manufacturers make when citing Japanese regulation is to write the wording of a Ministry of Health, Labour and Welfare notification as if it were statutory law. GRZAN requires internal documents to label the source type layer by layer precisely because this confusion changes how a citation is weighed in review correspondence, and because a citation that cannot be weighed cannot be defended.

• Act, cabinet order, and ministerial ordinance are legal sources; public notice and notification are not, though both bind practice.
• Certification standards live in public notices; operative interpretations live in notifications and PMDA guidance.
• Citations must state the layer, the instrument number, and the article, so the reader can weigh the source correctly.

2. Legal basis

The five layers, with their representative instruments, are set out below. Each layer is identified by the kind of instrument it contains, and the numbers are given in the form used for official citation.

1. Act layer: the Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products, Act No. 145 of 1960 (Showa 35); the renaming and restructuring were accomplished by Act No. 84 of 2013 (Heisei 25), promulgated November 27, 2013, effective November 25, 2014.
2. Cabinet order layer: the Enforcement Order of the PMD Act; Cabinet Order No. 268 of 2014 (effective date) and Cabinet Order No. 269 of 2014 (arrangement of related cabinet orders), both promulgated July 30, 2014; Article 37-21 of the Enforcement Order (periodic quality system conformity investigation) and Article 37-29 (review through the institution).
3. Ministerial ordinance layer: the Enforcement Regulations, MHW Ordinance No. 1 of 1961 (Showa 36); the QMS Ordinance, MHLW Ordinance No. 169 of 2004, promulgated December 17, 2004, most recently revised by MHLW Ordinance No. 87 of 2014; the medical device GCP ordinance, MHLW Ordinance No. 36 of 2005 (Heisei 17), most recently revised by MHLW Ordinance No. 128 of 2016 (Heisei 28).
4. Public notice layer: the public notices of the Ministry of Health, Labour and Welfare establishing certification standards and essential requirements for medical devices (under the mandates of Article 41, Paragraph 3 and Article 42, Paragraph 2 of the PMD Act).
5. Notification layer: Yakushoku-Hatsu 0806 No. 3 (August 6, 2014, implementation notification); Yakushoku-Kanpatsu 1114 No. 5 (November 14, 2014, qualification of program medical devices); Iyakuki-Shin-Hatsu 0331 No. 23 (March 31, 2026, handling of conditional approvals).

3. Expert insights

Insight one: the chapter structure of the QMS Ordinance is itself a product of layered thinking.

MHLW Ordinance No. 169 of 2004 is divided into 2 principal parts: Chapter 2 is integrated with the clauses of ISO 13485, while Chapter 3 and thereafter contain the additional requirements specific to Japan, corresponding in function to the GQP regime. Understanding this structure explains why holding an ISO 13485 certificate and satisfying the QMS Ordinance are two different things: the former covers Chapter 2, while the latter also demands Chapter 3, and the gap between them is exactly what a conformity investigation will probe.

Insight two: notifications are the true carrier of the operative interpretations.

Certification standards are issued in the form of public notices, but how the standards are to be used, how the dossier is to be organized, and how qualification is to be judged largely rest in notifications and PMDA guidance. Notifications have de facto binding force on both the administration and the regulated parties, and in submission practice their standing is no lower than that of ministerial ordinances. Ignoring the notification layer therefore leaves a team reading only half of the operative rules.

Insight three: citation practice must distinguish the layers.

The correct forms are, for example, Article 23-2-5, Paragraph 1 of the PMD Act (Act No. 145 of 1960), Article 114-8 of the Enforcement Regulations (MHW Ordinance No. 1 of 1961), and Chapter 2 of the QMS Ordinance (MHLW Ordinance No. 169 of 2004). Writing a notification as if it were a statutory provision destroys credibility in later review correspondence, because reviewers will read the over-claim as either carelessness or an attempt to inflate the source.

4. Practical recommendations

• Build an internal regulation ledger and label every entry with its layer and instrument number. Ledger fields should include the layer, the instrument name, the number, the promulgation date, the article cited, and the current status.
• Cite by layer in external documents. Acts and ministerial ordinances are cited as the basis; notifications are cited as the interpretation set out in the notification concerned.
• Recheck the amendment history on e-Gov periodically. The latest amendment dates and effective dates of acts follow the amendment history column on e-Gov, not dates compiled by third parties.
• Manage certification standards by their public notice numbers. Revisions to the standards directly affect the maintenance of already certified items and must be built into the change trigger conditions.

5. Verification checklist

• □ Does the internal regulation ledger label every entry with all four items: layer, instrument number, promulgation date, and article number?
• □ Has the wording of Ministry of Health, Labour and Welfare notifications been kept out of citations framed as statutory law?
• □ When citing the QMS Ordinance, is Chapter 2, the ISO 13485 integrated part, distinguished from Chapter 3, the Japan-specific additions?
• □ Are certification standards monitored for change under their public notice numbers?
• □ Have all dates been rechecked against the amendment history column of e-Gov?

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 manages PMDA submissions across Shonin/Todokede routes, coordinates J-QMS conformity, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com