December 6, 2017
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. Therefore, in early November, CFDA issued the basic requirements of the clinical evaluation for the IVD reagents exempt from clinical trials, in conjunction with “The Catalog of IVD Reagents Exempt from Clinical Trials,” to guide the applicants in conducting clinical evaluation of IVD reagents.
The content includes six parts: Application Scope, Basic Requirements, Clinical Evaluation Methods, Test Methods, Clinical Evaluation Reports and Other Evaluation Data. This guideline describes the basic requirements of clinical evaluation and related documentations. The main contents are as follows:
(1) Clarify the primary responsibility of the applicant. It is clearly stipulated that the applicant shall voluntarily conduct the clinical evaluation by themselves or entrust other institutions (or laboratories) to conduct the clinical evaluation in China. The process of testing shall be managed by the applicant. The evaluation report shall be signed by the applicant (or agent), and the authenticity of the test data shall be the responsibility of the applicant.
(2) The traceability of sample sources shall be emphasized. CFDA requires the raw data of the samples used for the clinical evaluation to be, at least, including the source, unique and of traceable number, age, sex, sample type and the background information.
(3) The test method of clinical evaluation shall be clearly defined. The applicant shall refer to the principles of relative methodological comparison to conduct the clinical evaluation, and the applicant shall select the appropriate statistical methods according to the characteristics of products to make sure the statistical analysis is objective and credible.