BIC offers customized Regulatory Consulting Services to Medical Device and IVD clients who wish to bring their products to the Japan market.
Regulatory Affairs Consulting
Strategy and Registration
Reimbursement
PMDA, MHLW Consultation and Meeting Support
Quality Management
Clinical Trials
Designated Marketing Authorization Holder (DMAH) services
BIC has First-Class (allowed to handle all classes) Marketing Authorization Holder (MAH) licenses, Manufacture licenses (packaging, labeling and storage), Repair licenses, and Sales licenses of Medical Devices and IVDs, which allow us to represent wide range of our client’s products in Japan.