[Home](/)/[Resources](/resources)/Japan PMD Act Provisions JapanMedical Devices # Japan PMD Act: What Medical Hardware Companies Must Know Beyond PMDA Registration Many medical hardware companies in Japan know about PMDA (Pharmaceuticals and Medical Devices Agency) and the Todokede/Ninsho/Shonin approval pathway. Fewer fully understand the ongoing obligations the Pharmaceutical and Medical Devices Act (薬機法, PMD Act — Act No. 145 of 1960, as fundamentally revised in 2014 and 2019) imposes after approval: GQP (Good Quality Practice) systems, GVP (Good Vigilance Practice) post-market surveillance, advertising restrictions stricter than most other markets, and the unique Japan-specific requirement for a Designated Marketing Authorization Holder (DMAH) who takes on legal responsibility in Japan. Getting the initial approval and then violating PMD Act provisions on advertising or post-market reporting is a common failure mode for foreign device makers that results in corrective actions and, in some cases, withdrawal of marketing authorisation. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fjapan-pmd-act-provisions) At a glance Governing law PMD Act (Act No. 145 of 1960) Key body PMDA + MHLW Foreign maker requirement Japan DMAH mandatory Adverse event (serious) 30 days to PMDA ## PMD Act obligations that outlast your initial approval ### The DMAH (Designated Marketing Authorization Holder) Foreign medical device manufacturers cannot hold a Japan marketing authorisation directly. They must appoint a DMAH — a Japan-based entity that is authorised by the prefectural government (or MHLW for higher-class devices) and takes on legal responsibility for the product in Japan. The DMAH files the approval application, holds the marketing authorisation, and bears legal liability for GQP and GVP compliance. Choosing and managing a DMAH relationship is one of the most consequential operational decisions for a foreign device maker in Japan. ### GQP: Good Quality Practice system The DMAH is required to implement a GQP (Good Quality Practice) system — a quality management system covering market surveillance, adverse event management, and product quality verification. GQP obligations for the DMAH are specified in MHLW Ministerial Ordinance No. 136. Foreign manufacturers are typically audited by the DMAH as part of GQP scope. The DMAH is responsible for confirming that the foreign factory's QMS remains consistent with the approved specifications — factory changes must be reported and assessed. ### GVP: Good Vigilance Practice and post-market reporting Post-market surveillance in Japan is governed by GVP (Good Vigilance Practice — MHLW Ministerial Ordinance No. 135). The DMAH must operate a vigilance system that: collects safety information from users and patients, evaluates adverse events, and reports to PMDA and MHLW within mandatory timelines. Serious unexpected adverse events must be reported within 30 days; deaths or life-threatening events caused by device malfunction within 15 days. The DMAH must submit periodic safety reports (期間中安全性更新報告書) for higher-class devices. ### Advertising restrictions under the PMD Act Japan has some of the world's strictest restrictions on medical device advertising. The PMD Act prohibits advertising that claims effects or performance beyond those stated in the approved marketing authorisation. Off-label claims in direct-to-consumer advertising are illegal; comparative advertising without specific regulatory basis is restricted; testimonials from physicians require specific format compliance. Violations of PMD Act advertising restrictions are criminal offences — the advertising provisions apply to any party distributing the advertising in Japan, including the foreign manufacturer's global marketing materials if accessed by Japanese consumers. ### Approval variation — changes requiring notification or approval Post-approval changes to a medical device — design changes, manufacturing site changes, software updates, labeling changes — must be assessed against MHLW's change notification and approval criteria. Minor changes can be handled by prior notification (事前届); significant changes (design modifications affecting safety, performance, or intended use) require a new partial change approval application (一部変更承認申請) before implementation. Implementing a change before obtaining the required approval is a PMD Act violation. ## How to build ongoing PMD Act compliance into your Japan operations 01 Establish and manage your DMAH relationship with clear contractual obligations covering: approval application timelines, GQP audit access, adverse event reporting, approval variation filing, and commercial terms. The DMAH relationship is a legal partnership, not just a regulatory filing service. 02 Implement a quality agreement with your DMAH that covers GQP obligations — specifically the information flow required for the DMAH to fulfill its GQP system requirements. This includes factory audit rights, change notification procedures, and adverse event information transfer timelines. 03 Establish an adverse event collection mechanism for Japan — a Japan-specific safety contact point and reporting procedure that meets GVP timelines. Your DMAH operates the GVP system in Japan, but the foreign manufacturer must feed it the information it needs within the regulatory reporting windows. 04 Review all marketing materials intended for Japan (including global materials accessible in Japan) against PMD Act advertising restrictions before deployment. All claims must be within the approved product labeling; off-label performance claims trigger PMD Act criminal liability. 05 Assess all post-approval product changes — hardware revisions, software updates, manufacturing site changes, component substitutions — against MHLW's change classification criteria before implementation. Build a change control process that requires regulatory impact assessment as a gate before engineering changes are finalised. ## Frequently asked questions ### Can a foreign company be its own DMAH in Japan? No — only Japan-based entities (with a Japan establishment) that are authorised by the relevant prefectural government can hold a marketing authorisation as a DMAH. A foreign company can establish a Japan subsidiary that applies for DMAH authorisation, but this is a substantial undertaking — the subsidiary must have a Japan-qualified quality assurance manager (総括製造販売責任者, sōkatsu seizō-hanbai sekinin-sha) and implement a full GQP/GVP system in Japan. Most foreign device makers initially use an established DMAH service provider rather than establishing their own. ### What is Japan's unique device identifier (UDI) requirement? Japan introduced a UDI (Unique Device Identification) requirement under the 2019 PMD Act amendments. Medical devices in Japan must carry a Japan-specific UDI — typically using GS1 or HIBC standards — and the UDI information must be registered in the PMDA's UDI database. The UDI implementation schedule phased by device class: Class IV (highest risk) devices were required to comply first, followed by Class III, Class II, and Class I on a staggered schedule. Confirm the current deadline for your device class with PMDA. ### How does Japan's 'Todokede' notification pathway differ from full 'Shonin' approval? Todokede (届出) is a notification pathway for Class I medical devices — the lowest-risk class — where the manufacturer notifies the prefectural government before marketing without pre-market review by PMDA. Ninsho (認証) is a certification pathway for Class II devices using designated third-party certification bodies against ministry-designated standards. Shonin (承認) is the full approval pathway requiring PMDA review, used for Class III and IV devices (highest risk) and for any device without a corresponding designated standard. Risk classification is the key determinant of which route applies. ### What are the penalties for PMD Act violations? The PMD Act's criminal penalty provisions include imprisonment of up to 3 years and fines up to JPY 3 million for violations by individuals; corporate fines can reach JPY 300 million. Marketing without a valid authorisation (operating without a DMAH, for example) and PMD Act advertising violations are the most commonly prosecuted categories. MHLW also has administrative powers — corrective action orders, suspension of manufacturing or marketing, and revocation of marketing authorisation. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇯🇵 Japan roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇯🇵 Japan compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $199](/courses/59-japan-pmda-medical-device-registration)[Prefer to read? Get the book — $34.99](/books/59-japan-pmda-medical-device-registration) Related guides * [Japan Medical Device RegistrationJapan's three-tier medical device system: Todokede notification, Ninsho certification, Shonin approval, and the DMAH requireme…](/guides/japan-medical-device-registration) * [Japan PSC Mark Consumer SafetyWhich specified products need Japan's PSC Mark, and the self-declaration conformity route under the Product Safety Act.](/guides/japan-psc-mark-consumer-safety) * [UAE Medical Device RegistrationMedical device registration in the UAE under the Emirates Drug Establishment (EDE, formerly MOHAP): agent and import permit re…](/guides/uae-medical-device-registration)