We
support procedure of medical device;
1. Registration of foreign manufacture
2. Registration 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 and 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 Approval or Certification
for the 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.
After you prepare the licenses, you will apply Approval or Certification for each device.
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