CHINA: NOTICE OF THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION ON ISSUING THE CATALOG OF MEDICAL DEVICES EXEMPTED FROM CLINICAL EVALUATION – SEPTEMBER/OCTOBER 2023

• 2023-09-27 07:45:33

NMPA revised the Catalog of Medical Devices Exempt from Clinical Evaluation (2021) and published the Catalog of Medical Devices Exempt from Clinical Evaluation (2023).

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China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

• 2020-02-14 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

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