Japan Medical Device Database
Explore 88,000+ registered medical devices in Japan. Free bilingual (English/Japanese) search powered by Pure Global AI - search by device name, PMDA ID, device class, or manufacturer from the official PMDA database.
What is the Japan PMDA database?
The PMDA (Pharmaceuticals and Medical Devices Agency) database is the official Japanese government registry of all approved medical devices in Japan. It contains comprehensive information about medical devices registered under the Pharmaceutical and Medical Device Act (PMD Act), including device specifications, manufacturers, marketing authorization holders, and regulatory approvals.
How many medical devices are in the PMDA database?
The PMDA database contains over 88,000 registered medical devices from both domestic Japanese manufacturers and international companies that have obtained approval to market their devices in Japan.
What information can I find for each device?
For each medical device, you can find the product name (Japanese and English), PMDA approval number, device classification, manufacturer information, marketing authorization holder (MAH), approval date, intended use, device specifications, and regulatory status. The database is bilingual to support international users.
What are the device classes in Japan?
Japan classifies medical devices into four classes based on risk: Class I (general medical devices - low risk), Class II (controlled medical devices - moderate risk), Class III (specially controlled medical devices - high risk), and Class IV (highly controlled medical devices - highest risk requiring clinical trials).
Can I search the database in English?
Yes, the database supports bilingual search in both English and Japanese. You can search using English keywords for device names, manufacturers, or company names. Results display information in both languages when available, making it accessible for international medical device companies.
What is the difference between manufacturer and MAH?
In Japan, the Marketing Authorization Holder (MAH) is the legal entity responsible for the device in the Japanese market, which may be different from the actual manufacturer. Foreign manufacturers typically work with a Japanese MAH (often a distributor or importer) who holds the regulatory approval and is responsible for post-market surveillance and compliance.
About This Database
This database is powered by Pure Global AI and provides free bilingual access to the official PMDA registry data. The information is updated regularly to reflect the latest medical device approvals and regulatory changes in Japan. Use this tool to research the Japanese medical device market, verify device registrations, or explore competitive products in Asia's largest medical device market.