Cobridge supports medical device manufacturers in their entry into the Japanese market, specifically with regulatory affairs consulting services to apply for marketing approval of their products and with Designated Marketing Authorization Holder (DMAH) services to perform regulatory quality and safety control activities after approval.
Cobridge has the most comprehensive license, a first class DMAH license for Medical Devices and IVDs, which allows us to act as DMAH for Class II through IV medical devices and IVDs and thus serve for wide-range of clients and their products.
Regulatory Affairs Consulting Services
- Consulting services related to regulatory affairs
- Assistance for consultation meetings with Japanese Pharmaceutical and Medical Devices Agency (PMDA) (Preparation of documents for consultation meetings, attendance the meetings with clients, and addressing queries from PMDA)
- Preparation of dossiers for pre-market approval application and addressing queris from PMDA
Designated Marketing Authorization Holder