PMDA · East Asia & Pacific

Japan medical device regulatory resources

Every Japan dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

26,105 certificate records11 free resources24/25 topics with records10 regulations trackedAug 2026 fees reviewed

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Medical device registration database

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Medical device registry insights

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Medical device regulations

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Registration timeline

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Government registration fees

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Medical device regulation news

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Additional certification and licence checker

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 45 source-linked facts →

24 of 25 research dimensions currently covered · 20 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: 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 (…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Governing legislation: 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. 169/200…

1 source-linked fact

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition: 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,…
IVD legal category: 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,…

3 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through IV.: Class I, Class II, Class III, Class IV

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Applications submitted via PMDA: Approval applications (new and partial change), except Cabinet Order designated exceptions, are submitted through PMDA (機構を経由).
Certification by registered certification body: 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 appoin…

5 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

China NMPA approval: not reference: statement: Japan's only foreign approval linked mechanism for devices is priority processing under PMD Act Art. 23 2 5(9) for devices already approved in a country designated by Cabinet Ord…
Medical Device Single Audit Program — qms audit reliance: 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 co…

3 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

MAH license classes: 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.
Representative or holder 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…

3 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Distribution/leasing license for high-risk devices: 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 pr…
Import proof at customs: 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 fore…

3 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Data reliability standards: 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 (ac…
Device approval dossier content: 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;…

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Electronic submission channels: 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 pl…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Electronic publication of precautions (e-IFU basis): 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 t…
Statutory label items: 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)…

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS conformity survey timing: 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 le…
QMS and audit evidence for market access: 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…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

PMDA/MHLW electrical/EMC evidence: Electrical safety
Radio Law technical conformity/Giteki: Wireless / radio
Terminal equipment conformity: Telecom terminal

6 maintained overlays

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D14

Fees

Verified

Shonin - Class II/III (Follow-on): ¥1,879,900
Shonin - Class IV (Follow-on): ¥3,080,600

8 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Verified

Class I (一般医療機器) · Pre-marketing notification (製造販売届, Todokede) to PMDA: 0 days
Third-party certification (認証) · Registered certification body (登録認証機関) under Art. 23-2-23: 0 days
New medical device application (新医療機器) · PMDA approval review (Shonin): 12 months

6 maintained pathways

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Authorization duration: 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 (O…
Five-year establishment cycles: 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…

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Change-control outcomes: 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)…
Minor change notification deadline: Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

3 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

Container coding requirement: 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 th…
GS1 code / package-insert linking registration: 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 c…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical evidence requirement: Device approval requires clinical trial results or MHLW accepted substitute evidence, explicitly including documentation created by analyzing information on individuals' physical/mental con…

1 source-linked fact

Checked 2026-08-25

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D20

Special access & derogation

Verified

Conditional approval: 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 po…
Emergency approval: 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 exceedin…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

GVP postmarket safety management standards: 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 th…
Use-results evaluation (re-examination): 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 examinatio…

2 source-linked facts

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Device ADR reporting deadlines: 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…
Vigilance duty holders: 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)).

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Authority recall/disposal orders: 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…
Recall reporting: 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…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

False or exaggerated advertising ban: 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.
Pre-approval advertising ban: Advertising the name, manufacturing method, efficacy, effects or performance of devices that require approval or certification is prohibited until the approval (incl. foreign special approv…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeal against PMDA dispositions: 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 f…

1 source-linked fact

Checked 2026-08-25

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Government fees

Full fee schedule (8 lines) →

PMDA registration fees in JPY · reviewed 2026-08-25

Fee line	Amount	Provenance
Shonin - Class II/III (Follow-on)	¥1,879,900	Verified
Shonin - Class IV (Follow-on)	¥3,080,600	Verified
Shonin - Class II/III (New, no clinical)	¥11,816,400	Verified
Shonin - Class IV (New, no clinical)	¥16,520,700	Verified

4 more fee lines on the full schedule · 8 of 8 rows source-verified

Registration timeline

Full registration timeline →

Pharmaceuticals and Medical Devices Agency (PMDA) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathway	Review clock	Planning total	Provenance
Class I (一般医療機器)(Pre-marketing notification (製造販売届, Todokede) to PMDA)	0 days	0 days	Verified
Third-party certification (認証)(Registered certification body (登録認証機関) under Art. 23-2-23)	0 days	5-6 months	Verified
New medical device application (新医療機器)(PMDA approval review (Shonin))	12 months	7.1-12 months	Verified
Improved device — clinical data (改良医療機器（臨床あり）)(PMDA approval review (Shonin))	9 months	6.5-8.8 months	Verified