offers detailed assistance to facilitate the entry of Medical Devices into business in Japanese market.
We are specialists in Pharmaceutical affair.
The regulatory affairs requirements Pharmaceutical and Medical device Act (PMD Act) in Japan are quite unique. Japanese complex system causes difficulties in submitting and it takes long approval time for applicants.
Medi-R Japan may help you by strategic and accurate service for your specific need. We are able to offer our knowledge of up-dated regulatory to accomplish successful compliance. We strongly support you with a wide experience of medical device approvals to minimize time and cost for your product approval and marketing in Japan.
Our vision is to support patients by introducing your effective medical devices smoothly in Japanese medical field. Let us work for you with a view to enhancing the quality of medical service.
*1: Pharmaceuticals and Medical Devices Agency
*2: Marketing Authorization Holder
*3: Quality Management System
*4: Good Manufacturing Practice
*5: Good Vigilance Practice
*6: Good Clinical Practice
*7: Good Post-marketing Study Practice
| Company Name | Medi-R Japan |
|---|---|
| Mail Address | Uotomi building 6F, 3-41-9, Hongo, Bunkyo-ku, Tokyo tel: +81-3-3811-8671 fax: +81-3-3811-8672 |
| Business contents | Consulting on Regulatory Affairs of medical device Support for entry into Japanese medical device markets |
5 minutes walk from Exit 5 of Hongo Sanchome Station on Tokyo Metro Marunouchi Line and Toei Oedo Line
8 minutes walk from Exit 3 of Tokyo Metro Chiyoda Line Yushima Station