Tokyo • New York
MIC International is a regulatory services and market research company based in Tokyo, Japan. We assist medical device companies with all regulatory applications, product approvals, marketing and reimbursement issues. MIC International is a wholly owned subsidiary of MIC Medical Corporation, one of the largest Contract Research Organizations (CRO) in Japan. MIC Medical and MIC International provide a complete solution for domestic and overseas manufacturers wanting to introduce products into the Japanese medical market.
MIC International is a fully licensed Marketing Authorization Holder (MAH) in Japan for all medical devices and pharmaceuticals. MIC International provides international manufacturers with “Designated Marketing Authorization Holder” (DMAH) service allowing manufacturers to retain regulatory approval through a neutral service provider.
Japan is the second largest medical device market in the world. Since the introduction of the new Pharmaceutical Affairs Law (PAL), considerable confusion and complexity has overwhelmed U.S. medical product manufacturers.
Services
- Designated Marketing Authorization Holder (DMAH) services
- Liaison with Pharmaceutical Medical Devices Agency (PMDA) or notified body
- Create application for medical product(s) (approval, certification or notification)
- Review all overseas data for potential use in Japanese approval application
- Translate all necessary documents required for approval application
- Partner with MIC Medical for any required Japan based clinical trials
- Liaison with Pharmaceutical Medical Devices Agency (PMDA) or notified body
- Strategic planning of regulatory affairs towards product approval
- Review of available documents and listing additionally required documents
- Market Research
- Prepare procedures regarding GVP, GQP
- Establish and maintain system for post-marketing safety
- Import approved products
- Introduce and establish Distributor partners for selling in Japan
To inquire about our services email us at: