PMD Act Name Change and the 2014 Restructuring

1. Key takeaways

The reform that took effect on November 25, 2014 amounted, in substance, to two new institutional mechanisms plus one expansion of scope: the attached documentation moved from being prepared by the company at its own discretion to being notified to the Minister of Health, Labour and Welfare and disclosed immediately; medical devices were given an independent chapter in the law; and third-party certification was extended from controlled medical devices to designated highly controlled medical devices. Chinese manufacturers who still understand Japan through the lens of the old Pharmaceutical Affairs Law era will underestimate compliance costs at exactly two points: the disclosure obligation for attached documentation and the scope of application of certification. Both underestimates share one root cause, namely reading the reform as a change of name when it was in fact a change of machinery.

• Attached documentation became a notified and immediately disclosed compliance object, no longer a company-prepared leaflet.
• Medical devices received their own chapter, decoupling device regulation from the drug chapter.
• Third-party certification opened to designated highly controlled medical devices, but only to those specifically designated.

2. Legal basis

The full set of instruments behind the 2014 reform is listed below. Because the reform was implemented through a cascade of orders and a notification, all five layers need to be cited together when reconstructing the legal position.

1. The Act for the Partial Revision of the Pharmaceutical Affairs Law and Other Acts, Act No. 84 of 2013 (Heisei 25), promulgated November 27, 2013, effective November 25, 2014.
2. The Cabinet Order on the effective date of the act, Cabinet Order No. 268 of 2014, promulgated July 30, 2014.
3. The Cabinet Order arranging related cabinet orders and transitional measures accompanying the enforcement, Cabinet Order No. 269 of 2014, promulgated July 30, 2014.
4. The ministerial ordinance arranging related ministerial ordinances, MHLW Ordinance No. 87 of 2014, promulgated July 30, 2014.
5. The implementation notification: the notification of the Director of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare on the enforcement of the act, Yakushoku-Hatsu 0806 No. 3, dated August 6, 2014.
6. The current statute: Act No. 145 of 1960 (Showa 35), whose title after the renaming includes medical devices.

3. Expert insights

Insight one: attached documentation changed from an accessory into a compliance object.

Under the former law, the attached documentation was explanatory material that the company shipped with the product. The revised law requires the manufacturing and marketing business operator to prepare it on the basis of the latest knowledge, to notify it, and to disclose it immediately on a website after notification. This means that attached documentation in Japan is a continuous compliance matter with a submission action, a disclosure action, and an update obligation, rather than a one-time deliverable. Teams that treat it as a static leaflet accumulate a silent backlog of outdated versions, and that backlog surfaces when a distributor audit or a vigilance report exposes the mismatch between the shipped document and the notified one.

Insight two: the boundary of the certification expansion is designation, not Class II membership.

Act No. 84 of 2013 opened third-party certification to highly controlled medical devices, but the way it did so was by having the Minister of Health, Labour and Welfare establish standards and designate the applicable items. Within Class III, therefore, only the designated items can follow the certification route, and the remainder still require approval. Equating Class III with certification outright is a common misreading that leads to route misassignment at the planning stage.

Insight three: the roughly eleven-month interval between promulgation and entry into force is the normal rhythm of major Japanese pharmaceutical revisions.

Promulgated on November 27, 2013 and effective on November 25, 2014, the reform was completed during that interval with 1 effective-date cabinet order, 1 arranging cabinet order, 1 arranging ministerial ordinance, and 1 bureau director notification. Understanding this rhythm helps in reading the staged implementation of the 2025 revision as the same legislative technique rather than as delay, and it should also shape internal planning: a new act on the books does not mean new obligations the next day, and the implementing instruments must be tracked alongside the act itself.

4. Practical recommendations

• Manage attached documentation as an independent deliverable. Maintain a version ledger for the Japanese attached documentation, with a named owner and a defined timing for each of the three actions: notification, disclosure, and revision.
• Verify designation rather than class membership. The sole basis for judging certification feasibility is whether the Ministry of Health, Labour and Welfare has established a certification standard for the generic name in question and has designated it accordingly.
• Health-check old approvals obtained before 2014. The attached documentation and labeling of legacy items may diverge from the current requirements of Article 63 and Article 63-2; remediation is best consolidated after the first post-entry change rather than piecemeal. A single remediation pass also keeps the audit trail clean, because each change request can carry its own documentation update instead of reviving unrelated gaps.
• Annotate the point in time whenever the former name is cited. Where internal documents refer to the Pharmaceutical Affairs Law, they should state that the reference is to the legal status before November 25, 2014.

5. Verification checklist

• □ Has the current title of the statute been confirmed on e-Gov as the Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products?
• □ Has a dual-action ledger for notification and disclosure of attached documentation been established?
• □ Is the certification feasibility judgment anchored to two facts: the existence of a certification standard and the existence of a designation?
• □ Is the point in time annotated wherever historical documents use the former law name?
• □ Are the promulgation dates of Cabinet Order No. 268 of 2014, Cabinet Order No. 269 of 2014, and MHLW Ordinance No. 87 of 2014 recorded as July 30, 2014?

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