China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials

by Grace Wang Sep 24, 2021

On Sept. 18, the National Medical Products Administration (NMPA) released the List of Medical Devices Exempted from Clinical Evaluation1 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Evaluation2. Both are scheduled to take effect on Oct. 1, 2021.

The former list covers 1,010 categories of Class II/Class III medical devices; the latter contains 423 categories of Class II/Class III IVD reagents. The categories are listed with names, functions and registration/filing classes. The lists make it easier for applicants to check whether their products fit into the categories.


Definition of Clinical Evaluation for Medical Devices/IVD Reagents in China

Definition of Clinical Evaluation for Medical Devices/IVD Reagents in China

Clinical Evaluation for Medical Device

Clinical Evaluation for IVD Reagent

Activities using scientific and reasonable methods to analyze and evaluate clinical data, and finally to confirm the safety and effectiveness of the medical device in its application scope.

Process using scientific and reasonable methods to analyze and evaluate clinical data to verify whether the IVD reagent product meets the needs for use or achieves the expected functions, and finally to prove the safety and effectiveness of the product.

References: Administrative Measures for Medical Device Registration and Filing3and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing4

 

Clinical Evaluation/Trial Exemption Conditions and Corresponding Submission Requirements

The two lists deserve stakeholders' attention because applicants can spare themselves from conducting clinical evaluation/trials if their products are eligible for exemption:

Grace Wang
ChemLinked Regulatory Analyst
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