Tel:+86-10-64187881 | E-mail: service@qiminer.com

  • Home
  • About
  • Registration Consulting
    • Imported Medical Device
    • Dental Products
    • GMP
    • IVD Reagent
    • Cosmetics
  • Clinical Trials
  • Translation
  • News
    • New Regulations
    • Industry News
    • Company News
  • Inquiry
    • Review progress
    • Regulations
    • Product Classification
  • Career
Imported Medical Device
  • Service Introduction
  • Registration Workflow
  • Classification Method
  • Technical Requirements and Testing
  • Clinical Trial
  • Document Requirements
  • Relevant Regulations
  • What are medical devices?

  • Which authority is responsible for the filing/registration of MDs?

  • What is the validity of filing/registration certificates?

  • What are the necessary data the distributor of a medical device must have?

  • What are technical specifications of a medical device?

Relevant Regulations

CFDA circular about registration approving work standard of domestic class III MDs and imported MDs.
CFDA circular about the directory of class II MDs exempted from clinical trial (No. 12, 2014)
CFDA circular about issues related to the filing of class I MDs (No. 26)
CFDA circular about the issue of class I MD directory (No. 8)
Measures for the Administration of Medical Device Registration
Regulations for the Supervision and Administration of Medical Devices


If you need to know more about the latest regulations or to have professional insights about the regulation, please contact us via:

Tel: 86-10-62253808

Email: service@qiminer.com

SITE MAP

  • Registration Consulting
  • Clinical Trials
  • News
  • Career
  • Q&A

QUICK LINKS

  • CFDA
  • CFDA MD Evaluation Center
  • PKU MD Testing Center
  • BJ Institute of MD Testing
  • National Institute for F&D Control

Contact Us

C-602, Ruipu Building, No. 15, Hongjunying South Road, Chaoyang District, Beijing 100012


Tel: +86-10-64187881


E-mail:service@qiminer.com


Contact online

© Beijing QME Consulting Co., Ltd.