In order to obtain marketing authorization to sell your medical device in Japan, you must first register your product with the Pharmaceuticals and Medical Devices Agency (PMDA). Besides market authorization, foreign manufacturers must also apply for Foreign Manufacturer Accreditation licenses, and renew them every five years.
All medical devices must receive authorization from the PMDA before they can be commercialized in the country. Your device's path to market in Japan depends on its classification, and whether similar products are already available in Japan. For more detailed information, see our PMDA approval process chart.
Let Emergo assist you in evaluating the Japanese medical device regulatory framework as it applies to your device(s)
Emergo has a worldwide network of in-house consultants as well as regulatory and industry contacts that enable us to provide incisive, actionable analysis on various medical device markets, including Japan. Our Global Regulatory Overview reporting service for Japan covers the following topics:
- PMDA Regulatory Background
- Foreign Manufacturer Accreditation Licensing
- Product Assessment
- Authorized Representation in Japan
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Japan Regulatory Roadmap
Please contact us for more information about our Regulatory Overview Report for Japan.