Today I bring you the distinction between clinical evaluation free and clinical evaluation: NMPA

After getting a project, the clinical needs to be evaluated route, can we take the clinical
evaluation free route or should we take the clinical evaluation? This is a question we often
struggle with.
Difference part1 (regulations):
Exemption from clinical evaluation regulations:
Notice of the State Drug Administration on the release of the catalogue of medical devices
exempted from clinical evaluation (No. 33 of 2023)
Technical Guidelines for Comparative Description of Products Included in the Catalogue of
Medical Devices Exempted from Clinical Evaluation
Clinical Evaluation Regulations:
Circular of the State Drug Administration on the Release of 5 Technical Guidelines for Clinical
Evaluation of Medical Devices and Other Technical Guidelines (No. 73 of 2021)

And guidelines for clinical evaluation of the same species that match your product. (Some
products have them, some don't)
Difference Part 2 (Definition).
Exempted from clinical evaluation, do not need to declare the product or the same species of
products ‘clinical data’ analysis, that is, do not need to submit ‘clinical data’; but need to be
demonstrated by the manufacturer why the declared product is ‘exempted from clinical
evaluation’ products. However, the manufacturer is required to demonstrate why the declared
product is ‘exempt from clinical evaluation’. Therefore, the exemption from clinical evaluation
needs to be compared with the catalogue of exempted products, and the basic classification code
should be the same.
Clinical evaluation is the ongoing activity of analysing and evaluating clinical data using
scientifically sound methods to confirm the safety, clinical performance and/or efficacy of a
medical device under its scope of application.
Therefore, clinical evaluation requires the analysis of clinical data, such as clinical literature,
clinical trial data analysis. (META analysis is described earlier on how to use software for META
analysis)
Differences Part 3 (Argument for equivalence)
Clinical evaluation needs to demonstrate equivalence, need to demonstrate that the same variety
of products and your product has the same nature, he can be selected as equivalent products,
based on regulations: medical device clinical evaluation of equivalence demonstration of
technical guidelines.
Differences Part 4 (registration information)
Free clinical evaluation is generally placed in a subsection, clinical evaluation is in a large chapter,
the need to increase the literature search report, based on regulations: medical device clinical
evaluation technical guidelines (No. 73 of 2021)
Summarise the route selection process:
① Compare the catalogue, and the catalogue is consistent, go free of clinical evaluation.
② Although the device classification code is inside the catalogue, but beyond the description of
the catalogue, must go clinical evaluation.
③ Devices not found in the catalogue must go for clinical evaluation.