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Support for entry into Japanese markets
1. Regulatory Services and Consulting
MIC Medical Corp has First-Class Licenses of Marketing Authorization Holder (MAH) of both Drug and Medical Device, and provides the following services as Designated MAH;
● D-MAH of Medical Device from Class��to��
● D-MAH of Drug and Diagnosis
● Manufacturing License Holder of Diagnosis (Packaging,Labeling and storage)
● Strategic Regulatory Planning: (Device Category of Application, Feasibility Study Report, Possibility of Applying with Foreign Study Data, and Others)
● Preparation of Application for Marketing Approval (Certification) and Support for PMDA (Pharmaceutical and Medical Devices Agency) Review
● Preparation of Application for License of MAH (Marketing Authorization Holder)
● Preparation of Documents on QMS/GQP/GVP and Consultation
● Health Insurance Reimbursement Application (A1,A2,B,C1,C2) and Consulting
● To support Drug Master File (DMF) registration in Japan
● To introduce labeling/packaging manufacturers and distributors in Japan
2. Clinical Development and Consulting
Thanks to the long term experience in foreign medical devices development, MIC provides the clients with suitable plan to obtain Marketing Approval within a short period. Our assistance is offered by well experienced experts engaged in regulatory affairs and clinical development at major pharmaceutical companies, and includes starting from preparation of clinical test, marketing approval application through correspondence with PMDA inquiry.
● Preparing Documents for PMDA Clinical Evaluation Consultation ;
Evaluation of necessity of clinical trial data
● Medical Writing: (Investigator Brochure, Protocol, Summary Report)
● Feasibility Estimate on using Foreign Test Data (non-clinical or clinical)
● Contract Monitoring and Dispatching Monitors
（Inquiry / Request for Brochure）
MIC Medical Corp.
Yushima Urban Bldg, 2-31-22 Yushima, Bunkyo-ku,Tokyo 113-0034 Japan
Business development Dept.
Hidenori Numata
Tel: +81-3-3818-8580 Fax：+81-3-3818-8570
Inquiry
（Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)
Direct Regulatory Affairs Dept.
Kenichi Sakamoto
Tel: +81-3-3818-8201 Fax：+81-3-3818-8570 Inquiry
（Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)
