Clinical Evidence — STED / PMDA Technical Dossier Requirements — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

The STED format and PMDA clinical evidence requirements are distinct from NMPA dossier structure. Existing NMPA clinical evaluation documents cannot be directly submitted to PMDA — they must be reformatted into STED and reviewed against Japan-specific PMDA guidance. Overseas (including Chinese) clinical data may be accepted by PMDA subject to ICH E5 ethnic considerations; PMDA may request a bridging study or Japan-based trial for novel devices. The PMDA review timeline for clinical dossiers averages 12–18 months for Class III/IV applications. PMDA pre-submission consultations (事前面談) are strongly advisable before filing.

Electrical Safety — JIS T 0601-1 / IEC 60601-1 for Electromedical Equipment — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

GB 9706.1-2020 and JIS T 0601-1:2023 share the IEC 60601-1 family as their technical foundation, but Japan's current edition and Japan-specific deviations must be reviewed directly. This is a meaningful partial alignment: test data generated under GB 9706 with NMPA-recognized lab reports may support JIS T 0601-1 conformance submissions, subject to review of Japan-specific deviations and additional requirements in JIS T 0601-1:2023. A gap analysis against JIS-specific annexes and deviations is required. Testing must be conducted by a laboratory acceptable to PMDA or the Registered Certification Body; NMPA-recognized labs may not be automatically accepted. EMC and home-use collateral standards must also be reviewed for differences.

Japanese Language Labelling Requirements (PMD Act Article 63) — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

All labelling and IFU must be in Japanese — Chinese-language labelling does not satisfy the PMD Act requirement. The Japanese IFU must follow the MHLW-specified format for 添付文書 which differs structurally from the NMPA IFU format. The MAH's name and address (not the Chinese manufacturer's) must appear as the responsible entity on the Japanese label. Authorization/certification/notification numbers assigned by PMDA/MHLW must be printed on the label, so labelling cannot be finalized before the marketing authorization is granted. Translation, format compliance, and regulatory review of the Japanese IFU add time and cost to market entry.

Marketing Authorization Holder (MAH) License and In-Country Representative Requirements — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

Japan's MAH system is a structural gap: the Chinese manufacturer must identify and contract a licensed Japanese MAH before any regulatory submission can begin. The MAH assumes legal liability under Japanese law — MAH selection, contractual terms (quality agreement, cost allocation for PMDA responses, GVP obligations), and transition rights are material commercial and regulatory decisions. Unlike an EU Authorised Representative (who has a narrower role), the Japanese MAH has comprehensive ongoing responsibilities. MAH fees, timeline, and willingness to take on Chinese device registrations vary widely.

PMD Act Market Authorization — Device Classification (届出 / 認証 / 承認) — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

Japan requires a licensed Japanese MAH (製造販売業者) to hold market authorization — a Chinese manufacturer cannot hold a Japanese approval directly. This is a structural gap with no NMPA equivalent: the Chinese NMPA registration is held by the manufacturer or its domestic agent, whereas in Japan the MAH license and product approval/certification/notification are held by the Japanese entity. Identifying and contracting a Japanese MAH is the first mandatory step. Device class under the PMD Act must be independently determined; it does not map 1:1 to NMPA class.

Foreign Manufacturer Registration (外国製造業者登録) as Prerequisite for MAH Application — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

Japan's Foreign Manufacturer Registration is a unique Japan-only prerequisite with no NMPA equivalent. The Chinese manufacturer must proactively provide all required site documentation to the Japanese MAH to enable the MAH to file the registration. Delays in this step directly delay the product approval/certification application timeline.

QMS Compliance — MHLW Ordinance No. 169 (Japan GQP/GVP/QMS Ordinance) — Home/clinical medical device (China → Japan (PMDA / PMD Act))?

Japan's Ordinance 169 adds Japan-specific GQP and GVP layers on top of the ISO 13485-aligned core. An ISO 13485 certificate or existing NMPA QMS approval does not automatically satisfy Ordinance 169 — the Japanese MAH must have a compliant GQP/GVP system, and the manufacturing site may be subject to a PMDA on-site inspection. Manufacturers should expect a PMDA facility inspection for Class III/IV devices and must budget for inspection preparation, potential corrective actions, and re-inspection cycles. ISO 13485 certification can reduce but not eliminate the inspection burden.

CROSS-STANDARD public interest · Home/clinical medical device

China-to-Japan Medical Device Compliance Gap Matrix

AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of common China home and clinical electromedical device documentation against Japan PMD Act (薬機法) market authorization, MAH licensing, Foreign Manufacturer Registration, MHLW Ordinance 169 QMS, JIS T 0601-1 electrical safety, STED clinical evidence, and Japanese-language labelling requirements.

Dataset 2026-06-11 Last verified 2026-06-12 7 rows

GAP MATRIX

Compliance Gap Matrix

Gap matrix
Compliance item	Common China baseline	Japan (PMDA / PMD Act)	Gap / action	Source + verification date
Clinical Evidence — STED / PMDA Technical Dossier Requirements	China requires clinical evaluation (临床评价) for Class II and III device registration under the Administrative Measures for Clinical Evaluation of Medical Devices (2021, NMPA Announcement No. 73). Clinical evaluation may be conducted via: (a) exemption catalogue (if the device type is listed); (b) equivalence comparison to a legally marketed predicate device; or (c) clinical trial conducted in China. The technical dossier structure differs from STED but covers similar content areas. NMPA clinical requirements for novel devices are also stringent and may require China-based clinical trials.医疗器械临床评价技术指导原则 (2021, NMPA Announcement No. 73) 医疗器械注册与备案管理办法 (2021, NMPA Order No. 47), Article 24 — clinical evaluation requirements	Japan requires a Summary Technical Documentation (STED) as the core of the technical dossier for Class II (承認 route), III, and IV device applications submitted to PMDA or a Registered Certification Body. The STED format aligns with the IMDRF STED guidance (adopted via MHLW/PMDA guidance). For Class III and IV devices, PMDA requires clinical evidence — this may consist of: (a) clinical trial data generated in Japan or an acceptable overseas clinical study; (b) literature-based clinical evaluation following a systematic review methodology; or (c) reference to a legally-marketed comparator device (比較対照品目) under applicable PMDA guidance. PMDA has published device-specific clinical evaluation guidance documents. Clinical data requirements are substantially more stringent for novel or high-risk devices, and PMDA may require a Japan-specific clinical trial if overseas data is not accepted.PMDA: STED Guidance for Medical Device Applications (based on IMDRF/STED WG/N1FINAL:2012) MHLW Notification on Clinical Evaluation of Medical Devices (薬食機参発 series — verify current notification number via PMDA website) PMD Act Articles 23-2-5, 23-2-9 — Approval application requirements including clinical data	The STED format and PMDA clinical evidence requirements are distinct from NMPA dossier structure. Existing NMPA clinical evaluation documents cannot be directly submitted to PMDA — they must be reformatted into STED and reviewed against Japan-specific PMDA guidance. Overseas (including Chinese) clinical data may be accepted by PMDA subject to ICH E5 ethnic considerations; PMDA may request a bridging study or Japan-based trial for novel devices. The PMDA review timeline for clinical dossiers averages 12–18 months for Class III/IV applications. PMDA pre-submission consultations (事前面談) are strongly advisable before filing.	Pharmaceuticals and Medical Devices Agency (PMDA)2026-06-12 · unverified
Electrical Safety — JIS T 0601-1 / IEC 60601-1 for Electromedical Equipment	China requires electromedical equipment to conform to the GB 9706 series, which is a national adoption of IEC 60601-1 with China-specific annexes. GB 9706.1-2020 adopts IEC 60601-1:2005+AMD1:2012 (Ed. 3.1) and became mandatory for new registrations from 2023-05-01. Test reports from NMPA-recognized testing laboratories demonstrating GB 9706 conformance are required as part of the NMPA registration technical dossier. EMC requirements are covered by YY 9706.102 (adopting IEC 60601-1-2:2014).GB 9706.1-2020 (adopted IEC 60601-1:2005+AMD1:2012) — mandatory from 2023-05-01 for new NMPA registrations YY 9706.102-2021 (adopted IEC 60601-1-2:2014) — EMC requirements	Japan requires electromedical equipment to conform to JIS T 0601-1, the Japanese Industrial Standard for medical electrical equipment basic safety and essential performance. The current edition is JIS T 0601-1:2023, which incorporates Japan-specific deviations and additional requirements. JIS T 0601-1 is referenced in the MHLW certification standard (認証基準) for many Class II electromedical devices and is cited as a technical requirement in PMDA technical guidance for Class III/IV approval applications (承認申請). Applicable collateral standards (JIS T 0601-1-2 for electromagnetic compatibility, JIS T 0601-1-11 for home healthcare, etc.) and particular standards (JIS T series for specific device types) are also required where applicable. Test reports demonstrating conformance must be provided in the technical dossier submitted to PMDA or the Registered Certification Body.JIS T 0601-1:2023 — Medical electrical equipment Part 1: General requirements for basic safety and essential performance, with Japan-specific deviations JIS T 0601-1-2 — EMC requirements for medical electrical equipment JIS T 0601-1-11 — Requirements for medical electrical equipment used in home healthcare MHLW Certification Standards (認証基準) for specific Class II electromedical device types PMDA Technical Guidance for specific Class III/IV device approval applications	GB 9706.1-2020 and JIS T 0601-1:2023 share the IEC 60601-1 family as their technical foundation, but Japan's current edition and Japan-specific deviations must be reviewed directly. This is a meaningful partial alignment: test data generated under GB 9706 with NMPA-recognized lab reports may support JIS T 0601-1 conformance submissions, subject to review of Japan-specific deviations and additional requirements in JIS T 0601-1:2023. A gap analysis against JIS-specific annexes and deviations is required. Testing must be conducted by a laboratory acceptable to PMDA or the Registered Certification Body; NMPA-recognized labs may not be automatically accepted. EMC and home-use collateral standards must also be reviewed for differences.	Japanese Industrial Standards Committee (JISC)2026-06-12 · unverified
Japanese Language Labelling Requirements (PMD Act Article 63)	China requires Chinese-language labelling under the Measures for the Administration of Medical Device Instructions for Use and Labels (医疗器械说明书和标签管理规定, NMPA Order No. 6, 2014, amended 2022). Mandatory elements include the device name, registration/filing number, manufacturer name and address, specifications, intended use, contraindications, warnings, instructions for use, and manufacturing date/expiry. Chinese-language IFU is mandatory. Electronic labels are permitted under specific conditions per 2022 amendments.医疗器械说明书和标签管理规定 (NMPA Order No. 6, 2014, amended 2022)	PMD Act Article 63 and MHLW Ministerial Ordinance on Standards for Medical Device Labelling (医療機器の表示等に関する規則) require that medical devices sold in Japan carry Japanese-language labelling. Mandatory label elements include: (a) name and address of the MAH (製造販売業者); (b) name of the device; (c) authorization/certification/notification number; (d) manufacturing number or manufacturing symbol; (e) expiration date or storage conditions where applicable; (f) instructions for use in Japanese; (g) warnings and contraindications in Japanese; and (h) for devices subject to special restrictions, additional required statements. The Instructions for Use (添付文書, IFU) must be in Japanese and follow the format specified in MHLW guidance. Electronic IFU (e-IFU) is permitted under specific conditions introduced via 2021 PMD Act amendments.Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), Article 63 — Labelling of Medical Devices MHLW Ministerial Ordinance on Standards for Medical Device Labelling (医療機器の表示等に関する規則) MHLW Guidance on Medical Device Package Inserts (添付文書) — verify current notification number via PMDA website at pmda.go.jp	All labelling and IFU must be in Japanese — Chinese-language labelling does not satisfy the PMD Act requirement. The Japanese IFU must follow the MHLW-specified format for 添付文書 which differs structurally from the NMPA IFU format. The MAH's name and address (not the Chinese manufacturer's) must appear as the responsible entity on the Japanese label. Authorization/certification/notification numbers assigned by PMDA/MHLW must be printed on the label, so labelling cannot be finalized before the marketing authorization is granted. Translation, format compliance, and regulatory review of the Japanese IFU add time and cost to market entry.	Pharmaceuticals and Medical Devices Agency (PMDA)2026-06-12 · unverified
Marketing Authorization Holder (MAH) License and In-Country Representative Requirements	China does not have a separate MAH licensing tier equivalent to Japan's 製造販売業許可. Under NMPA rules, the device registration certificate (注册证) is held by the manufacturer (or its China-based authorized agent for imported devices). An imported device registration certificate is held by a China-incorporated entity acting as the import registration applicant. There is no post-market GVP ordinance equivalent to Japan's separate GVP obligations — post-market surveillance and adverse event reporting are governed by the Measures for the Supervision and Administration of Medical Device Adverse Events (2019) under the manufacturer/agent.医疗器械注册与备案管理办法 (2021, NMPA Order No. 47) — registration certificate holder 医疗器械不良事件监测和再评价管理办法 (2019, NMPA/NHC Joint Order No. 1)	Under the PMD Act, only a licensed Japanese entity holding a 製造販売業許可 (Manufacturing and Sales Business License) may hold a marketing authorization (approval/certification/notification) for a medical device sold in Japan. There are three license grades (第一種, 第二種, 第三種製造販売業) corresponding to device risk class. The MAH is legally responsible for product quality, post-market surveillance (GVP), and adverse event reporting under Japanese law. Foreign manufacturers cannot hold the MAH license directly; they must appoint a licensed Japanese MAH. The MAH is also responsible for registering the foreign manufacturer's site (外国製造業者登録) and for all regulatory submissions to PMDA/MHLW. MAH selection is a critical early decision — exiting a MAH relationship requires product re-approval.Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), Articles 12–14, 23-2-2 — Manufacturing and Sales Business License MHLW Ordinance No. 169 — GQP responsibilities of MAH MHLW Ordinance on Standards for Post-Marketing Safety Activities (GVP Ordinance, 薬発 series)	Japan's MAH system is a structural gap: the Chinese manufacturer must identify and contract a licensed Japanese MAH before any regulatory submission can begin. The MAH assumes legal liability under Japanese law — MAH selection, contractual terms (quality agreement, cost allocation for PMDA responses, GVP obligations), and transition rights are material commercial and regulatory decisions. Unlike an EU Authorised Representative (who has a narrower role), the Japanese MAH has comprehensive ongoing responsibilities. MAH fees, timeline, and willingness to take on Chinese device registrations vary widely.	Pharmaceuticals and Medical Devices Agency (PMDA)2026-06-12 · unverified
PMD Act Market Authorization — Device Classification (届出 / 認証 / 承認)	China NMPA classifies devices as Class I (filing/备案, provincial), Class II (registration/注册, provincial NMPA), or Class III (registration/注册, national NMPA) under the Administrative Measures for the Registration and Filing of Medical Devices (2021, NMPA Order No. 47). The Chinese manufacturer or its authorized agent holds the registration certificate. For general electromedical devices, Class II and III registrations with a national or provincial NMPA technical review are the typical path.医疗器械注册与备案管理办法 (2021, NMPA Order No. 47) 医疗器械监督管理条例 (2021, State Council Order No. 739)	Japan's Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act, 薬機法) establishes four device classes. Class I (general devices, 一般医療機器): notification (届出) to PMDA only, no prior authorization needed. Class II (controlled devices, 管理医療機器): either third-party certification (第三者認証) by a Registered Certification Body (登録認証機関) for devices covered by a certification standard, or MHLW/PMDA approval (承認) for devices not covered. Class III and IV (specifically controlled devices, 高度管理医療機器): MHLW approval (承認) via PMDA review is mandatory. The Marketing Authorization Holder (MAH, 製造販売業者) must hold a license (製造販売業許可) and submit the application; foreign manufacturers cannot self-apply and must work through a licensed Japanese MAH.Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), Law No. 145 of 1960 as amended — Articles 13, 14, 23-2-2, 23-2-3, 23-2-5 Pharmaceutical and Medical Device Act Enforcement Ordinance (薬機法施行令) PMDA: Overview of Medical Device Approval/Certification/Notification — pmda.go.jp	Japan requires a licensed Japanese MAH (製造販売業者) to hold market authorization — a Chinese manufacturer cannot hold a Japanese approval directly. This is a structural gap with no NMPA equivalent: the Chinese NMPA registration is held by the manufacturer or its domestic agent, whereas in Japan the MAH license and product approval/certification/notification are held by the Japanese entity. Identifying and contracting a Japanese MAH is the first mandatory step. Device class under the PMD Act must be independently determined; it does not map 1:1 to NMPA class.	Pharmaceuticals and Medical Devices Agency (PMDA)2026-06-12 · unverified
Foreign Manufacturer Registration (外国製造業者登録) as Prerequisite for MAH Application	China has no direct equivalent requirement. NMPA registration is held by the manufacturer directly (or its authorized agent in China). There is no separate 'foreign manufacturer site registration' step analogous to Japan's 外国製造業者登録; the manufacturing site information is submitted as part of the NMPA registration dossier.医疗器械注册与备案管理办法 (2021, NMPA Order No. 47)	Under PMD Act Article 23-2-4, a foreign manufacturer whose devices are to be distributed in Japan by a Japanese MAH must register with MHLW as a Foreign Manufacturer (外国製造業者登録). The registration must cover the specific manufacturing site and the device category. The Japanese MAH submits the registration application on behalf of the foreign manufacturer. The registration number is cited in the marketing approval/certification application. Failure to register the manufacturing site invalidates the MAH's product application.Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), Article 23-2-4 — Foreign Manufacturer Registration MHLW Notification on Foreign Manufacturer Registration Procedures	Japan's Foreign Manufacturer Registration is a unique Japan-only prerequisite with no NMPA equivalent. The Chinese manufacturer must proactively provide all required site documentation to the Japanese MAH to enable the MAH to file the registration. Delays in this step directly delay the product approval/certification application timeline.	Ministry of Health, Labour and Welfare (MHLW)2026-06-12 · unverified
QMS Compliance — MHLW Ordinance No. 169 (Japan GQP/GVP/QMS Ordinance)	China requires QMS/GMP compliance for Class II and III device manufacturers under the current Medical Device Production Quality Management Specification (医疗器械生产质量管理规范, NMPA Order No. 64, 2014), which remains enforceable until 2026-11-01. On 2026-11-01, NMPA Announcement No. 107 of 2025 (released 2025-11-04; 15 chapters and 132 articles) takes effect, aligning China's medical-device GMP more closely with the MAH system and ISO 13485:2016; manufacturers are in active transition. NMPA and provincial NMPA conduct on-site QMS inspections as part of registration. YY/T 0287-2017 (equivalent to ISO 13485:2016) provides the harmonized technical standard. China does not separately require Japan-style GVP or GQP obligations tied to a Japanese MAH entity.医疗器械生产质量管理规范 (NMPA Order No. 64, 2014; current Chinese medical-device GMP enforceable until 2026-11-01) NMPA Announcement No. 107 of 2025 (released 2025-11-04; effective 2026-11-01; 15 chapters/132 articles; MAH system and ISO 13485:2016 alignment) YY/T 0287-2017 (equivalent to ISO 13485:2016)	MHLW Ordinance No. 169 (2004, as amended; commonly referred to as the QMS Ordinance, 医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令) establishes Japan-specific QMS requirements for medical devices and IVDs. The ordinance is aligned with ISO 13485 but incorporates Japan-specific provisions, including requirements tied to the MAH's quality management responsibilities (GQP — Good Quality Practice) and post-market safety activities (GVP — Good Vigilance Practice). Class II, III, and IV device manufacturers and their Japanese MAH must operate QMS compliant with Ordinance 169. PMDA conducts on-site QMS inspections (製造所調査) of manufacturing sites — including foreign sites — as part of the approval process for Class III and IV devices, and for Class II where a certification standard does not cover the QMS.MHLW Ordinance No. 169 (2004, as amended) — QMS Ordinance for Medical Devices and IVDs (医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令) ISO 13485:2016 Medical devices — Quality management systems (referenced basis for Ordinance 169 alignment) PMD Act Articles 23-2-5, 23-2-7 — Manufacturing site approval and QMS inspection obligations	Japan's Ordinance 169 adds Japan-specific GQP and GVP layers on top of the ISO 13485-aligned core. An ISO 13485 certificate or existing NMPA QMS approval does not automatically satisfy Ordinance 169 — the Japanese MAH must have a compliant GQP/GVP system, and the manufacturing site may be subject to a PMDA on-site inspection. Manufacturers should expect a PMDA facility inspection for Class III/IV devices and must budget for inspection preparation, potential corrective actions, and re-inspection cycles. ISO 13485 certification can reduce but not eliminate the inspection burden.	Ministry of Health, Labour and Welfare (MHLW)2026-06-12 · unverified

INFORMATIONAL ONLY

Informational only / not a certification conclusion

AI-compiled, not human-verified. This comparison is generated and cross-checked by multiple AI models from public official sources; it has not been reviewed by a named human expert and may contain errors or out-of-date items. Confirm every requirement directly with the official regulator or standards body and a qualified professional before relying on it. Nothing here is legal, certification, customs, or market-access advice.

This page is an informational comparison aid, not a certification decision, legal opinion, PMDA review outcome, Registered Certification Body opinion, clinical evaluation, QMS audit result, customs determination, or market-access approval. Exporters, importers, manufacturers, and Marketing Authorization Holders should verify current Japan PMD Act classification, approval/certification/notification route, MAH licensing, Foreign Manufacturer Registration, QMS, labelling, and post-market obligations with qualified Japanese regulatory professionals before shipment or placing on the market.

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SOURCES

Official-source register.

Pharmaceuticals and Medical Devices Agency (PMDA) · accessed 2026-06-12 · unverified · used in 4 rows
Japanese Industrial Standards Committee (JISC) · accessed 2026-06-12 · unverified · used in 1 rows
Ministry of Health, Labour and Welfare (MHLW) · accessed 2026-06-12 · unverified · used in 1 rows
Ministry of Health, Labour and Welfare (MHLW) · accessed 2026-06-12 · unverified · used in 1 rows