Supporting medical device applications/Kawasaki Legal Services at Osaka Japanmedical device applications/Kawasaki Legal Services at Osaka Japan www.kawasakihoumu.com

Medical device/Kawasaki Legal Services at Osaka Japan
_ Procedure of medical device
_ Location
_ Links

_ Japanese
License for medical device/Kawasaki Legal Services at Osaka Japan
License for medical device/Kawasaki Legal Services at Osaka Japan License for medical device/Kawasaki Legal Services at Osaka Japan Kawasaki Legal Services at Osaka Japan
  Procedure of Medical Device
 

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.

Pharmaceutical Affairs Law ( Enforcement on April 1, 2005 )
Required System Responsible person Specially controlled medical devices Controlled medical devices General medical devices
ClassⅢ・Ⅳ
(Ⅱb・Ⅲ)
Class  Ⅱ
(Ⅱa)
Class  Ⅰ
  川崎法務事務所 医療機器製造業 矢印
QMS
(ISO13485)
Manager Registration of Foreign Manufacture
  川崎法務事務所 医療機器製造業 矢印
QMS
Quality Management System
Responsible engineering supervisor Registration for Manufacture
  川崎法務事務所 医療機器製造業 矢印
GVP
Good Vigilance Practice
Safety manager The marketing supervisor-general No. 1 type No. 2 type No. 3 type
QMS
Quality Management System
Quality assurance manager License for Marketing Approval Holder
  川崎法務事務所 医療機器製造業 矢印

Supervisor Retailing
License Notification None
Business license for medical device/Kawasaki Legal Services at Osaka Japan
Consumers / Medical persons

 

行政書士 川崎 一

〒537-0013
大阪市東成区
大今里南3丁目1-1
TEL:06-6977-1501
FAX:020-4665-7887
Hajime Kawasaki Administrative Lawyer

3-1-1, Oimazatominami,
Higashinari, Osaka 
TEL: +81-6-6977-1501
www.kawasakihomu.com
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