Clinical Consultation

Service introduction：

1. Exemption from clinical evaluation

For medical device products that are exempt from clinical evaluation, the relevant information submitted should be classified as "other information" in the non clinical data.

The specific requirements are as follows: For Class II and Class III medical devices that are exempt from clinical evaluation, the applicant shall demonstrate the safety and effectiveness of the products in accordance with the "Technical Guidelines for Comparing and Explaining Products Listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation" from the aspects of basic principles, structural composition, performance, safety, and applicability.

For disposable medical devices, supporting materials proving that they cannot be reused should also be provided.

2.Clinical evaluation of the same type

The clinical evaluation and clinical trial data of the same type are all classified as "clinical evaluation data". Except for products that are exempt from clinical evaluation catalogs, many conventional products on the market can be clinically evaluated by comparing them with the same type of medical devices.

If clinical evaluation is conducted through the same type of clinical evaluation pathway, comparative data should be submitted between the declared product and the same type of medical device in terms of applicability, technical characteristics, and biological characteristics; Clinical data of the same type of medical devices should be collected, evaluated, and analyzed to form clinical evidence. If applicable, the differences between the declared product and the same type of medical device should be described, and sufficient scientific evidence should be submitted to prove that the two have the same safety and effectiveness.

Clinical evaluation quotation CER

(Comparison with the same variety)

Domestic and foreign clinical data of registered products

Contents of Overseas and domestic CER 

Domestic and foreign clinical trial data of the previous generation of registered products

3. Clinical trials

When other data sources (such as non clinical trials, existing clinical data, etc.) cannot demonstrate the product's compliance with the basic principles of safety and performance (including safety, clinical performance and/or effectiveness, as well as the acceptability of benefit/risk ratios), clinical trials need to be conducted.

If clinical evaluation is conducted through the clinical trial pathway, the clinical trial protocol, written opinion from the ethics committee of the clinical trial institution agreeing to conduct the clinical trial, clinical trial report, sample of informed consent form, and the clinical trial database (original database, analysis database, explanatory documents, and program code) should be submitted.