Support for entry into foreign markets
MIC provides support for introduction of medical devices to US and Europe through our long-term experience and partnership with overseas consultants.
MIC's services extend further to advice and consulting for regulatory affairs in Asia-Pacific and South America. Such global regulatory consultation is possible due to liaison with leading local affiliated CROs and MIC International in Tokyo, which focus its services for support for entry into USA and EU.
1.The services for US by using American staff with a lot of experience in FDA include;
* Strategic Regulatory Planning: (Negotiation with FDA, Device Category of Application, Necessary documents)
* Support of electrical Manufacturing site registration & device listing at FDA Website
* Preparation of submission documents
* Support for GMP inspection by FDA
2. Regulatory Services and Consulting for EU
MICI provides Regulatory Services and Consulting for EU through joint work with local consultant group and provides following services;
* Authorized Representative
* Preparation of Technical files
* Establishing software quality system in compliance to IEC 62304
MIC International Corp.
San-aijisyo Bldg 4F, 4-1-17 Hongo, Bunkyo-ku,Tokyo 113-0033 Japan
Tel: +81-3-3818-8577 Fax：+81-3-3818-8577
（Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)