Support for entry into Japanese markets

1. Regulatory Services and Consulting

MIC Medical has a First-Class License as a Marketing Authorization Holder (MAH) or both Drugs and Medical Devices.

MIC provides the following services as a designated MAH (dMAH, d-MAH):

 

  •  ・d-MAH (dMAH) of Medical Devices from ClassⅠto Ⅳ
  •  ・d-MAH (dMAH) of Drug and IVD
  •  ・Manufacturing License Holder of IVD (Packaging, Labeling and Storage)
  •  ・Strategic Regulatory Planning: (Device Category of Application, Feasibility Study Report, Potential of using Foreign Clinical, etc.)
  •  ・Preparation of Application for Marketing Approval/Certification
    (Shonin/Ninsho: Japan Marketing License) and Support for PMDA (Pharmaceutical and Medical Devices Agency) Review
  •  ・Preparation of Application for License of MAH (Marketing Authorization Holder)
  •  ・Preparation of Documents for Japan QMS/ Japan GQP/ Japan GVP
  •  ・Health Insurance Reimbursement Application (A1, A2, B, C1, C2)
  •  ・Support Japan Drug Master File (DMF) registration
  •  ・Introduce partner labeling/packaging and/or shipping manufacturers and distributors within Japan

2. Clinical Development and Consulting

Due to our long term experience with foreign medical device development, MIC provides clients with appropriate guidance to obtain Japan Marketing Approval within a short period of time. Our services are provided by our well experienced expert staff engaged in regulatory affairs and clinical development, many with work history at major pharmaceutical companies. Services encompass all aspects from preparing a clinical study to submitting a marketing approval application to corresponding with PMDA until final Japan Marketing approval.

  •  ・Preparing Documents for PMDA Clinical Evaluation Consultation: Evaluation of necessity of clinical trial data
  •  ・Medical Writing: (Investigator Manual, Protocol, Summary Report)
  •  ・Feasibility on using Foreign Test Data (clinical)
  •  ・Contract Monitoring and Dispatching Monitors
(Inquiry / Request for Brochure)
MIC Medical Corp.
Business development Dept.
Hidenori Numata
Tel: +81-3-6880-9650 Fax:+81-50-3153-1522
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(Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)


Direct Regulatory Affairs Dept.
Kenichi Sakamoto
Tel: +81-3-6880-9310 Fax:+81-3-6880-9314
icon Inquiry

(Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)