Japan
Japan is the third largest medical device market in the world, characterized by high standards and a strong orientation toward innovation.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authorities are the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).
Device Classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Very high risk
Specific Local Requirements
| Language | Documentation in Japanese. |
| Marketing Authorization Holder (MAH) | Required for foreign manufacturers. |
| Certifications | CE and FDA certifications are helpful, but Japan-specific standards are mandatory. |
Challenges and Operational Advice
- Long timelines: High-risk devices may require up to 24 months for approval.
- Specific regulations: Unique requirements demand expert local support.
Why Choose ISEMED
- Asian Expertise
Experience with Japanese approval processes. - Localized Support
Collaboration with Japanese partners for MAH and translations.
FAQ
- Is a local representative required? Yes, MAH.
- Documentation language? Japanese.
- License duration? Unlimited, subject to regulatory changes.