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
Clinical Trials
  • Service Introduction
  • Workflow
  • Clinic Bases
  • 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

Directory of Medical Devices Exempted from Clinical Trials (Second Batch)
Good Clinical Practice for Medical Devices
Technical Guidance on Clinical Evaluation of IVD Reagents
Directory of Class II Medical Devices Exempted from Clinical Trials
Directory of Class III Medical Devices Exempted from Clinical Trials




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.