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IVD Reagent
  • Service Introduction
  • Registration Workflow
  • Classification Method
  • Technical Requirements and Testing
  • Clinical Trial
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  • 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

Measures for the Administration of IVD Reagents

Guidelines for the compiling of IFU for IVD reagents

Guidelines for clinical trial techniques for IVD reagents

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

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QUICK LINKS

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

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