🇯🇵 Japan medical device regulatory data

Product approvals (承認) and certifications (認証) have no statutory expiry under the PMD Act; the recurring 5-year obligations are the MAH license (Order Art. 36), manufacturer registration (Order Art. 37-7), foreign manufacturer registration (Order Art. 37-13), and QMS conformity survey interval (Order Arts. 37-21/39).

Foreign manufacturer registration (and likewise domestic manufacturer registration, Order Art. 37-7) runs on a 5-year validity cycle; QMS survey periods under the RCAB route are likewise 5 years (Order Art. 39).

Changes to approved items split into: partial-change approval for anything beyond Ordinance-defined minor changes (Art. 23-2-5(13)) and notification for minor (軽微な) changes (Art. 23-2-5(14)); the certification route mirrors this split via the certifying RCAB (Art. 23-2-23(7)/(8)).

Not minor (thus requiring approval-level change review): adding/changing/deleting intended use or effects; changes to methods for inactivating/removing pathogenic factors; and any change MHLW deems to affect quality, efficacy or safety (Rule Art. 114-25(1)); IVD analogs in Art. 114-25(2) (incl. changes to reaction-system components).

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

A foreign manufacturer of certified designated products must notify the certifying registered certification body within 30 days of changing its appointed Japan MAH (or changes to the MAH's details) (Art. 23-3(2)); MAH-side events such as business suspension/closure or changes to the 総括製造販売責任者 are notified to MHLW within 30 days (Art. 23-2-16(1)).

Only holders of the class-matched MHLW marketing license may market devices/IVDs as MAH: 高度管理医療機器 → 第一種医療機器製造販売業許可; 管理医療機器 → 第二種; 一般医療機器 → 第三種; IVDs → 体外診断用医薬品製造販売業許可.

Foreign manufacturers of devices/IVDs exported to Japan register each manufacturing site with MHLW (医療機器等外国製造業者登録); product approval is refused if the manufacturing site lacks domestic registration (Art. 23-2-3) or foreign registration (Art. 23-2-4) (Art. 23-2-5(2)(ii)).

MHLW (Minister of Health, Labour and Welfare) grants device/IVD marketing approval (承認, Art. 23-2-5(1)); PMDA (機構) conducts the approval review and QMS conformity surveys on MHLW's behalf (Art. 23-2-7(1)); registered certification bodies (登録認証機関) certify MHLW-designated products (Art. 23-2-23(1)).

Core framework: Pharmaceuticals and Medical Devices Act (Act No. 145 of 1960, as amended), with Enforcement Cabinet Order No. 11/1961, Enforcement Rule No. 1/1961, QMS Ordinance No. 169/2004 (manufacturing/quality control) and GVP Ordinance No. 135/2004 (postmarket safety management).

A medical device (医療機器) is a machine, instrument or similar article intended for diagnosis, treatment or prevention of disease in humans or animals, or to affect body structure or function, designated by Cabinet Order; regenerative medicinal products are excluded.

Software that is a medical device (医療機器プログラム) is explicitly in scope: providing it over telecommunication lines constitutes marketing (製造販売) and is regulated like any other device marketing.

IVDs are regulated as 体外診断用医薬品 (in-vitro diagnostic drugs): drugs used solely for disease diagnosis that are not applied directly to the human or animal body. Their approval, MAH licensing, manufacturer registration and postmarket rules follow the medical-device chapter of the PMD Act (e.g., Arts. 23-2, 23-2-3, 23-2-4, 23-2-5).

Route depends on class/designation: Class III/IV (高度管理医療機器) and non-designated products require product-by-product MHLW approval (承認, Art. 23-2-5(1)); MHLW-designated products (mainly Class II 管理医療機器 and designated IVDs, some Class III) require third-party certification (認証) by a registered certification body (Art. 23-2-23(1)); remaining Class I (一般医療機器) need only prior notification (届出, Art. 23-2-12(1)). QMS conformity assessment applies separately.

MHLW-designated 高度管理医療機器/管理医療機器/IVDs (指定高度管理医療機器等) are certified product-by-product by a registered certification body (登録認証機関); foreign manufacturers market through a Japan MAH they appoint (選任製造販売業者).

Devices and IVDs outside the approval and certification designations (i.e., Class I 一般医療機器 and non-designated IVDs) are marketed after a prior product notification (届出) to MHLW by the MAH.

A foreign manufacturer of approval-route devices exported to Japan may itself hold the approval (外国製造医療機器等特例承認, Art. 23-2-17): MHLW grants approval product-by-product for marketing through a Japan MAH the foreign manufacturer appoints (選任製造販売業者).

Approval applications (new and partial change), except Cabinet-Order-designated exceptions, are submitted through PMDA (機構を経由).

Devices already approved in a country with an approval system of equivalent standard to Japan's qualify for priority add-on processing (faster review and surveys ahead of other products, Art. 23-2-5(9)); the only designated country is the United States.

PMDA accepts MDSAP audit results and, where appropriate, streamlines the survey procedures for QMS conformity-survey applications (evidence reuse at the QMS-audit layer only; a local QMS conformity decision and product authorization are still required).

Selling, granting, leasing (or displaying for such purposes) 高度管理医療機器 (Class III/IV) or 特定保守管理医療機器 requires a distribution or leasing license (販売業/貸与業許可); providing the equivalent device programs over telecommunication lines is equally covered.

Domestic entities manufacturing devices/IVDs as a business — including design — must register each applicable manufacturing site (design, assembly, sterilization or other Ordinance-designated processes) with MHLW.

An MAH importing devices/IVDs for marketing must, by the time of customs clearance, hold a document proving for each product that an approval or approval application, a notification, a foreign special approval (or application), or a certification (or application) exists.

Device approval dossier (Rule Art. 114-19) comprises: development history incl. foreign use status; design and development verification; conformity to Art. 41(3) standards; risk management; manufacturing method; clinical trial results or MHLW-accepted substitutes (incl. documentation analyzed from real-world clinical data); postmarket survey plan (PMSP Ordinance 38/2005); and safety-information/labeling documentation. Application on form 様式第六十三の八 with MAH license copy (Rule Art. 114-17).

Nonclinical safety data must meet device GLP Ordinance No. 37/2005 and clinical trial data device GCP Ordinance No. 36/2005 (both 2005 MHLW Ordinances), plus data-integrity requirements (accurate creation; handling of unfavorable findings).

Current online submission surfaces: PMDA electronic submission data system (gateway system, esg.pmda.go.jp), MHLW FD申請 (web.fd-shinsei.mhlw.go.jp), and the medical device WEB application platform DWAP (www.dwap.pmda.go.jp) for device programs/submissions.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and prescribed precautions for designated devices.

When marketing, the MAH must publish current precautions/safety information (注意事項等情報), based on the latest literature and other knowledge, by electronic/ICT means — the statutory basis of the electronic package insert (電子添文) system.

Japan QMS is set by MHLW Ordinance No. 169 of 2004 (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), the standards referenced in Art. 23-2-5(2)(iv) (also applied to foreign special approvals via Art. 23-2-17(5)); conformity is verified by MHLW/PMDA or RCAB surveys — a plain ISO 13485 certificate is not a substitute, while MDSAP results can streamline the survey (from 2022-04-01).

For designated products, the manufacturer must undergo a document-based or on-site QMS conformity survey (書面/実地調査) by MHLW when seeking approval and again every Cabinet-Order period (not less than 3 years; set at 5 years — Order Arts. 37-21 and 39); successful survey yields the 基準適合証 (conformity certificate).

Device containers/wrappers must bear a number, symbol or code (符号) — by an Ordinance-prescribed electronic/ICT method — enabling retrieval of the published precautions (注意事項等情報); this is the statutory basis for GS1-code (UDI-style) device identification.

PMDA operates electronic package inserts (電子添文) and a registration linking device/IVD package inserts with GS1 codes (introduced by MHLW notification of 2020-11-11, 薬生安発0311第1号), enabling code-based retrieval of current IFU information.

Device approval requires clinical trial results or MHLW-accepted substitute evidence, explicitly including documentation created by analyzing information on individuals' physical/mental conditions obtained from medical care (real-world data); clinical trials must satisfy device GCP Ordinance No. 36/2005.

MHLW may grant conditional approval (条件付承認) for rare-disease (希少疾病用), pioneer (先駆的) or special-use (特定用途) devices/IVDs, attaching conditions including implementation of Ordinance-defined postmarketing surveys.

緊急承認: MHLW may approve devices/IVDs needed urgently to prevent spread of serious health harm where no adequate alternative exists, attaching use-assurance conditions and a term not exceeding 2 years (extendable under the same article).

MAH postmarketing safety management (製造販売後安全管理) must comply with MHLW Ordinance No. 135 of 2004 (GVP), the standards designated under Arts. 12-2(1)(ii), 23-2-2(1)(ii) and 23-21(1)(ii) of the PMD Act.

For MHLW-designated devices/IVDs, the approval holder must apply within 3 months after the end of the MHLW-directed survey period for the use-results evaluation (使用成績評価) — the re-examination of the approval.

Device MAHs and foreign special-approval holders report to MHLW: within 15 days — malfunction-suspected deaths, serious cases unpredictable from precautions (incl. foreign identical-device malfunctions), infections, and foreign recall/suspension measures; within 30 days — other serious cases/malfunctions and trend changes; periodically — within 2 months after each 1-year period from approval (malfunctions with foreseeable death/serious risk and other specified trends).

The ADR/safety-information reporting duty lies on the MAH and on foreign special-approval holders (外国特例承認取得者); healthcare professionals have a separate reporting duty (Art. 68-10(2)).

Recalls by MAHs/foreign special-approval holders are reported promptly after initiation to MHLW (or prefectural governor where delegated) with specified items (recaller, product identifiers incl. approval/certification/notification numbers, lots/quantities, sites, export destinations, initiation date, method, planned completion, further measures), plus change reports and prompt completion reporting.

MHLW or prefectural governors may order persons handling devices to dispose of, recall, or take other measures sufficient to prevent public-health danger (e.g., defective devices, products whose approval was revoked).

No person may advertise, describe or disseminate false or exaggerated claims — explicit or implicit — about the name, manufacturing method, efficacy, effects or performance of devices.

Advertising the name, manufacturing method, efficacy, effects or performance of devices that require approval or certification is prohibited until the approval (incl. foreign special approval) or certification is obtained.

Applicants can file a formal appeal (審査請求) with MHLW against PMDA dispositions (other than review results) or inaction in medical-device reviews; MHLW is treated as PMDA's superior agency for the appeal.