Japan is the world’s second-largest medical device market and an important target for Chinese medical device companies going global. Its regulatory system is known for being rigorous and detailed. Based on official interpretations from Japan’s Ministry of Health, Labour and Welfare (MHLW) and industry practice guides, this article gives a one-stop overview of Japanese medical device registration – legal framework, risk classification, market pathways, core standards and practical experience – to help you enter the Japanese market efficiently and compliantly.
The main law governing medical devices in Japan is the Act on Pharmaceuticals and Medical Devices (PMD Act), renamed from the former Pharmaceutical Affairs Law in November 2014, which together with the following regulations forms the complete regulatory system:
Regulators
Ministry of Health, Labour and Welfare (MHLW): responsible for regulation-making and final approval.
Pharmaceuticals and Medical Devices Agency (PMDA): responsible for technical review, post-market oversight, adverse event monitoring and relief for adverse health effects
2. Japan’s Medical Device Classification System
Japan uses risk-based classification with four classes:
Japan’s classification corresponds to the GHTF risk classes:
Class I → Class A
Class II → Class B
Class III → Class C
Class IV → Class D
3. The JMDN Coding System
Japan uses the JMDN (Japanese Medical Device Nomenclature),
which is based on the global GMDN.
Code structure: the first 5 digits are the GMDN main code, and the last 3 digits are Japanese subdivisions
Of these, the 6th digit reflects the risk class and the last 2 digits are used for product subdivision
Before registration, companies must first confirm the JMDN code.
4. Pathways to the Japanese Market
Class I – premarket notification (Todokede)
Features: no PMDA technical review or approval; the company itself confirms conformity with the Essential Principles
Applies to: low-risk devices, general consumables
Premarket certification (Ninsho)
Applies to: Class II with certification criteria, some Class III products
Who reviews? A Registered Certification Body (RCB), similar to an EU Notified Body (NB).
Common submissions: product specifications, risk analysis, performance testing, conformity with the Essential Principles, declaration of conformity to standards
Premarket approval (Shonin)
Applies to: Class II without certification criteria, Class III and Class IV
Innovative products must submit: complete technical documentation, clinical evaluation, stability data, risk management files
Manufacturing information – PMDA classification logic: the PMDA distinguishes new devices, improved devices and generic devices, and clinical requirements differ greatly between routes.
5. Japan’s System of Certification Standards
Certification Criteria
Mainly for: generic devices, substantially equivalent products
Features: third-party certification possible, cites JIS/ISO standards, requires demonstration of conformity with the Essential Principles
Approval Criteria
For: products not requiring clinical data
Features: uniform technical requirements, high consistency of approvals
Review Guidelines
Used for: safety and effectiveness assessment, reference for PMDA technical review
Especially relevant to: innovative and improved devices
6. Key Points of Recent Regulatory Amendments in Japan
In recent years Japan has strongly promoted faster market access for innovative devices.
SAKIGAKE designation system
For: products developed globally in parallel, products with clear clinical advantages
Advantages: priority consultation, a dedicated reviewer, shorter approval times
Priority review for specific uses
For: pediatric devices, devices related to antimicrobial resistance (AMR), products addressing high unmet needs
Conditional approval system
Features: allows data to be supplemented after launch, accelerating market access for innovative products
PACMP (post-approval change management protocol)
Companies can submit in advance changes to specifications, manufacturers or components, so that no new application is needed each time after approval.
This greatly improves product iteration efficiency.
7. Core Requirements for Foreign Companies Entering Japan
A MAH must be appointed
MAH (Marketing Authorization Holder)
i.e. the Japanese marketing authorization holder, which must be a Japanese legal entity.
Registration of overseas manufacturing sites
Activities requiring registration include design and development, manufacturing, sterilization and filling
Establish a Japanese QMS
Japan’s QMS is based on ISO 13485 but is stricter,
with particular emphasis on design control and life-cycle risk management
Accept on-site audits
Japan accepts MDSAP certificates, which can replace part of PMDA on-site audits.
8. Japanese Registration Documentation Requirements
Common documents include:
Product specifications
Risk analysis (ISO 14971)
Performance testing
Stability studies
Clinical evaluation
Sterilization validation
Conformity with the Essential Principles
Manufacturing process documents
All submitted documents must be in Japanese
9. Japanese Registration Timelines and Fees
10. Post-Market Regulation in Japan
Japan uses three main safety systems:
Safety review
Post-market surveillance
Relief for adverse reactions
Adverse events can be reported electronically, by post or in person
The PMDA performs data analysis, causality assessment and risk trend analysis
In recent years Japan has made extensive use of:
Data mining
Sentinel hospital networks
Proactive risk alerts
11. Practical Advice for Companies
1. Confirm classification early
Key questions: is the product substantially equivalent, and is it an innovative device?
2. Choose a MAH early
The quality of the MAH directly affects registration efficiency.
3. Make full use of fast tracks
For example: SAKIGAKE, priority review for specific uses, conditional approval
4. Build the QMS early
Recommendation: pursue ISO 13485 and MDSAP in parallel.
5. Seek professional support
Japanese regulations have strict documentation requirements, high Japanese-language standards and detailed review logic; a professional team can greatly improve the success rate.
12. FAQ
Q1: What is the core of Japan’s medical device regulation?
A: The PMD Act (Act on Pharmaceuticals and Medical Devices).
Q2: Does Class I require approval?
A: No, only notification.
Q3: What is the difference between third-party certification and PMDA approval?
A: Third-party certification applies to products with existing standards; PMDA approval applies to high-risk and innovative products.
Q4: Can foreign companies apply directly?
A: No, a Japanese MAH must be appointed.
Q5: Does Japan accept MDSAP?
A: Yes, it can replace part of the on-site audits.
Conclusion
The Japanese market has high entry barriers but equally rich rewards. For Chinese medical device companies:
whoever understands the logic of Japanese regulation earlier will find it easier to seize opportunities in the Japanese market.
If you are planning to enter Japan, contact us for:
Japanese medical device classification support
JMDN code confirmation
MAH introductions
Japanese QMS coaching
PMDA registration consulting
With many years’ experience in global medical device market access compliance, we have helped many Chinese manufacturers enter major markets including the US, the EU (Germany), Canada, Japan and Southeast Asia. Whether your target is the rigorous German market, the high-barrier Japanese market or the high-potential Southeast Asian market, we can design a tailored compliance plan based on practical experience to help you open up global markets quickly.
Reference links
MHLW website:
https://www.mhlw.go.jp/english/
PMDA website:
https://www.pmda.go.jp/english/index.html
PMDA standards database:
https://www.pmda.go.jp/english/review-services/standards/