NMPA adjusts production license for imported medical devices

On:
In: Import & export, License, Medicine/medical devices
On September 25, the national medical product administration issued an announcement to adjust the domestic production license of imported medical devices (class II and class III). If the main raw materials and production processes are not changed and the quality management system is consistent, some of the approved original application materials can be used for the registration for domestic production. The documentation of overview, research data, clinical evaluation data, product risk analysis data of medical device products, in vitro diagnostic reagent products, research data of main raw materials (when applicable), research data of main production process and reaction system (whenRead More →

Thank you for your interests/registration! For complete and full access to our platform, please contact us to subscribe as a paid-up member. The annual fee is ＄5,500 Best! Paolo yue Email: yuefeng7832@hotmail.com Cell: 008613501397114

Existing Users Log In
   
New User Registration
*Required field

Related posts:

  1. Approval of domestic class III and imported medical devices
  2. Measures for registration and filing of medical devices
  3. Measures for registration and filing of medical devices
  4. Electronic registration certificate of medical devices
  5. Regulations on Customized Medical Devices (Trial)
  6. Class III medical devices subject to clinical trials 2020
  7. NMPA:Regulations on vaccine production and circulation
  8. SAMR: Adjustment of Production License Management
  9. Rules for Unique Identification of Medical Devices
  10. Adjustment of Production License for Industrial Products