Policy Diagram: “Amendments to the Registration Management Measures of in Vitro Diagnostic Reagents”

Share:

Share on facebook
Share on twitter
Share on pinterest

Understanding to the “Amendments to the Registration Management Measures of in Vitro Diagnostic Reagents”

The reason of the amendments:

  • The development of in vitro diagnostic technology, the increase of usage amount
  • Insufficient adjustment space of Article 17,18 and 19.
  • The adjustment of related product category and risk are mismatched
  • The regulatory requirements of medical device are not met

The Amendments define clearly that China Food and Drug Administration is entitled to adjust the classification according to the risk changing of in vitro diagnostic reagents to leave space for the adjustment of classification rules and directories in the future

Which Amendments are included?

The follow clause:

“China Food and Drug Administration is responsible to the development and adjustment of classification rules and directories of in vitro diagnostic reagents.”

is changed to:

“The classification rules of in vitro diagnostic reagents described in Article 17, 18 and 19 will be used to guide the development and adjustment of the classification directory of the in vitro diagnostic reagent and determine the new management category of the in vitro diagnostic reagents. The classification rules can be adjusted by China Food and Drug Administration according to risk changing of the in vitro diagnostic reagent. “


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.

Related Posts