We
support procedure of medical device;
1. Accreditation of foreign manufacture
2. License for manufacture
3. License for marketing approval holder
4. License for retailing
5. Marketing approval of medical device
6. Certification to market designated controlled medical device
7. Nortification of marketing bussiness
8. Preparing and supporting QMS, GQP, GVP
9. Consultation of most kind of procedre of medical divice including
advertisement and recall
Japanese Pharmaceutical Affairs Law requires
two categories of license.
One is for identities, and the other is for a medical device
itself.
All licenses and/or approval must be met before you sell in
Japan.
Follow
is constraction of JP license system of medical device.
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