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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.

88,166 approval records11 free resources25/25 requirements covered10 regulations trackedAug 2026 fees reviewed
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Everything we track for Japan

Medical device registration database

Search official PMDA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official PMDA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

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AI registration cost and timeline planner

Estimate the likely PMDA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

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AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Japan requirements.

AI similar registered product finder

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Regulatory requirements data

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

Structured regulatory requirements

Explore all 44 source-linked facts →

25 of 25 research dimensions currently covered · 20 official sources · latest verification 2026-09-07

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
Open details →
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
Open details →
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,…
Software as medical device
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.
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
Open details →
D05

Registration pathways

Verified
Market-access route or official registration surface
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…
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
Open details →
D06

Reliance & recognition

Verified
US-approval priority add-on review
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, Ar…
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D07

Economic-operator roles

Verified
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…
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.
3 source-linked facts
Checked 2026-08-25
Open details →
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…
Manufacturer registration (incl. design)
Domestic entities manufacturing devices/IVDs as a business — including design — must register each applicable manufacturing site (design, assembly, sterilization or other Ordinance designat…
3 source-linked facts
Checked 2026-08-25
Open details →
D09

Dossier requirements

Verified
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;…
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…
2 source-linked facts
Checked 2026-08-25
Open details →
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
Open details →

Submission & evidence

D11

Label, IFU & language

Verified
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)…
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…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Verified
PMDA/MHLW electrical/EMC evidence
Electrical safety
Radio Law technical conformity/Giteki
Wireless / radio
Terminal equipment conformity
Telecom terminal
6 maintained overlays
Checked 2026-09-07
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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
Open details →
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
Open details →

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)…
New-application triggers
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 MH…
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
Open details →
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
Open details →
D23

Recall, FSCA & market surveillance

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
Open details →
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
Open details →
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
Open details →

Government fees

Full fee schedule (8 lines) →

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

Fee lineAmountProvenance
Shonin - Class II/III (Follow-on)¥1,879,900Verified
Shonin - Class IV (Follow-on)¥3,080,600Verified
Shonin - Class II/III (New, no clinical)¥11,816,400Verified
Shonin - Class IV (New, no clinical)¥16,520,700Verified
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 / pathwayReview clockPlanning totalProvenance
Class I (一般医療機器)(Pre-marketing notification (製造販売届, Todokede) to PMDA)0 days0 daysVerified
Third-party certification (認証)(Registered certification body (登録認証機関) under Art. 23-2-23)0 days5-6 monthsVerified
New medical device application (新医療機器)(PMDA approval review (Shonin))12 months7.1-12 monthsVerified
Improved device — clinical data (改良医療機器（臨床あり）)(PMDA approval review (Shonin))9 months6.5-8.8 monthsVerified
2 more pathways on the full timeline · 6 of 6 clocks source-linked
  1. 1Device Classification(2-4 weeks)
  2. 2Appoint MAH/DMAH(4-8 weeks)
  3. 3Foreign Manufacturer Accreditation(1-2 months)
  4. 4QMS Compliance(2-4 months)
  5. 5Pre-Submission Consultation(1-3 months)
  6. 6Shonin/Ninsho Application(1-2 weeks)
  7. 7PMDA Review(10-14 months)
  8. 8Approval(2-4 weeks)

Latest regulation news

All Japan regulation news →

Newest official PMDA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 31M/MHLW / PMDA / registered certification bodiesPMDA Software as a Medical Device Consultation Schedule UpdatedJapanAug 31M/MHLW / PMDA / registered certification bodiesPMDA Updates Consultation Schedule for Office of Software as a Medical DeviceJapanAug 28M/MHLW / PMDA / registered certification bodiesJapan MHLW and PMDA Publish Pharmaceuticals and Medical Devices Safety Information No. 430JapanAug 28M/MHLW / PMDA / registered certification bodiesMHLW Pharmaceuticals and Medical Devices Safety Information No. 430JapanAug 28M/MHLW / PMDA / registered certification bodiesPMDA Notification on Updated Approved Companion Diagnostics (CDx) for Identifying Eligible PatientsJapan

Key regulations

All 10 Japan regulations →

Official PMDA rules and guidance · 10 of 10 documents linked to official sources

PMDAPharmaceuticals and Medical Devices Agency - Official Portal
GeneralVerified
PMD Act (Act No. 145 of 1960)Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
GeneralVerified
PMD Act Amendments 2024Latest PMD Act Amendments and Updates
GeneralVerified
Shonin ApprovalMedical Device Regulations and Approval/Certification
RegistrationVerified

Registry insights

Full registry statistics →

Computed from 88,166 official PMDA approval records · data as of 2025-02-19

88,166
Approvals
3,461
Manufacturers
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