Japan Product Registration & Certification
Important Notes
- PMDA Review & MHLW Approval: Pharmaceuticals and medical devices undergo technical review by the Pharmaceuticals and Medical Devices Agency, with final approval from the Ministry of Health, Labour and Welfare.
- Marketing Authorization Holder (MAH) System: Foreign manufacturers must designate a "Marketing Authorization Holder" in Japan, typically a registered subsidiary or exclusive代理, assuming full responsibility for quality, safety, and post-marketing.
- Medical Device Classification & "Ninsho"/"Todokede": Devices are classified I-IV. Class I requires notification (Todokede), some Class II require third-party certification (Ninsho), and Class III/IV require PMDA approval (Shonin).
- Master File (MF) System: Active pharmaceutical ingredient manufacturers must register a confidential MF with PMDA for reference by drug applicants. Foreign manufacturers can register a Foreign MF via their MAH or Japanese代理.
- Japanese Labeling & "Patient Package Insert": All product labels and instructions must be in Japanese. Drugs also require an easy-to-understand "Patient Package Insert."
- Pricing & NHI Listing: Drug and some device prices are set by the Central Social Insurance Medical Council. Inclusion in the National Health Insurance price list is a core step for market access.
Japan Specific Requirements
- One of the World's Highest-Standard Review Systems: The PMDA-led review system is renowned as one of the most rigorous and detailed globally, with lengthy but highly transparent, predictable processes and deep reviewer interaction.
- Strict Price Control under NHI: As the single payer, the NHI enforces strict cost containment and international price referencing. New drug pricing is based on complex added-value calculations and comparison with other countries.
- Extreme Demand for Local Data & "Suitability for Japan": Clinical development strongly recommends inclusion of Japanese patient data. Review heavily focuses on the product's suitability within Japanese medical practice and population.
- Highly Mature & Hierarchical Market Structure: The market consists of large hospitals, clinics, and pharmacy networks with stable channel relationships, demanding extremely high product quality, service, and long-term commitment.
- Accelerated Pathways & Conditional Approvals for Innovation: Schemes like SAKIGAKE designation and conditional early approval exist to expedite breakthrough therapies, but require stringent post-marketing studies.
Medical Devices Registration
Regulatory Requirements
- Marketing Authorization
- Classification according to Pharmaceuticals and Medical Devices Act (General/Controlled/Highly Controlled)
- Technical documentation (including drawings, specifications, etc.)
- Quality Management System compliance (QMS/QMR)
- Japanese labeling and instructions
- Clinical data (required for Controlled/Highly Controlled devices)
Main Process
- Product classification determination
- Technical documentation preparation
- Domestic MAH designation
- PMDA application submission
- Quality system audit
Registration Timeline
12-36 months
Official Fees
¥500,000 - ¥8,000,000
Service Fees
$30,000 - $120,000
Regulatory System Overview
PMDA
Pharmaceuticals and Medical Devices Agency
Responsible for technical review, safety monitoring, and relief services for medical devices and pharmaceuticals, operating under MHLW
MHLW
Ministry of Health, Labour and Welfare
Responsible for developing regulations and policies for medical devices, cosmetics, and pharmaceuticals, the highest health administration authority in Japan
CAA
Consumer Affairs Agency
Responsible for Foods with Function Claims notifications and Foods for Specified Health Uses approvals, protecting consumer rights and food safety
Medical Devices Registration Process
Product Classification
Determine medical device risk classification according to PMD Act (General/Controlled/Highly Controlled)
Technical Documentation
Prepare Japanese technical documentation, test reports, performance verification data
Domestic MAH Designation
Designate Japanese domestic Marketing Authorization Holder
PMDA Application
Submit marketing authorization application to PMDA, including technical review
Quality System Audit
Pass PMDA on-site quality system audit (for Controlled/Highly Controlled devices)
Cosmetics Registration
Regulatory Requirements
- Cosmetic Notification
- Ingredient compliance confirmation (Japan Cosmetic Ingredient Standards)
- Japanese labeling requirements
- Good Manufacturing Practice certification
- Strict compliance with ingredient use restrictions
Main Process
- Ingredient compliance assessment
- Japanese labeling preparation
- Notification application submission
- Japanese Responsible Person designation
- Post-market surveillance establishment
Registration Timeline
3-8 months
Official Fees
¥100,000 - ¥800,000
Service Fees
$10,000 - $25,000
Regulatory System Overview
PMDA
Pharmaceuticals and Medical Devices Agency
Responsible for technical review, safety monitoring, and relief services for medical devices and pharmaceuticals, operating under MHLW
MHLW
Ministry of Health, Labour and Welfare
Responsible for developing regulations and policies for medical devices, cosmetics, and pharmaceuticals, the highest health administration authority in Japan
CAA
Consumer Affairs Agency
Responsible for Foods with Function Claims notifications and Foods for Specified Health Uses approvals, protecting consumer rights and food safety
Cosmetics Registration Process
Ingredient Compliance
Confirm all ingredients comply with Japan Cosmetic Ingredient Standards (JSCS)
Japanese Labeling
Prepare product labels and instructions compliant with PMD Act requirements
Responsible Person
Designate Japanese marketing responsible person (for product safety and quality)
Notification Submission
Submit cosmetic notification through MHLW electronic filing system
Post-market Management
Establish adverse reaction monitoring and reporting system
Health Foods Registration
Regulatory Requirements
- Foods with Function Claims notification
- Foods for Specified Health Uses approval
- Nutrition labeling compliance
- Japanese labeling requirements
- Scientific evidence for functional claims
Main Process
- Product classification determination
- Scientific evidence preparation
- Notification/approval application
- Labeling compliance confirmation
- Consumer Affairs Agency review
Registration Timeline
6-24 months
Official Fees
¥200,000 - ¥2,000,000
Service Fees
$15,000 - $50,000
Regulatory System Overview
PMDA
Pharmaceuticals and Medical Devices Agency
Responsible for technical review, safety monitoring, and relief services for medical devices and pharmaceuticals, operating under MHLW
MHLW
Ministry of Health, Labour and Welfare
Responsible for developing regulations and policies for medical devices, cosmetics, and pharmaceuticals, the highest health administration authority in Japan
CAA
Consumer Affairs Agency
Responsible for Foods with Function Claims notifications and Foods for Specified Health Uses approvals, protecting consumer rights and food safety
Health Foods Registration Process
Product Classification
Determine category: General Food, Foods with Function Claims, or Foods for Specified Health Uses
Scientific Evidence
Prepare scientific literature evidence and safety data for functional ingredients
Notification Application
Submit FFC notification or FOSHU approval application to Consumer Affairs Agency
Labeling Review
Ensure labeling complies with Food Labeling Act and specific product category requirements
Post-market Surveillance
Establish product safety and quality monitoring system, regular reporting to authorities