Appendix
Basic Requirements for Clinical Evaluation Materials of
IVD Exempted from Clinical Trial (Draft)
According to Article 29 of Provisions of In-vitro Diagnostic Reagent Registration
(Decree No.5 of China Food and Drug Administration), for the in-vitro diagnostic
reagents exempted from clinical trials, the applicant or filing entity shall evaluate the
clinical performance of in-vitro diagnostic reagents through non-clinical trial methods
such as assessment on the clinical samples covering intended use and interference
factors as well as comprehensive literatures. The requirements are stipulated as a
guidance for the registration applicant to evaluate the clinical performance of in-vitro
diagnostic reagents and for the Food and Drug Administration to review the clinical
evaluation materials.
- Applicable scope
These requirements are suitable for the application of product registration and
alteration related to clinical evaluation for in-vitro diagnostic reagents on the list of
clinical trial exempt (this is briefly referred as “Catalogue” in the following context).
No distinction is made about the methods for the products on the “Catalogue” when
there is no special explanation.
The applicant who is not able to evaluate the clinical performance according to the
requirements for products on the “Catalogue” shall conduct the clinical trial.
The following circumstances are not within the requirements and clinical trial is
conducted as required in conformity with the Guidance on Clinical Trial for In-vitro
Diagnostic Reagent:
(1) Product on the “Catalogue” does not have definite principle, finalized design and
developed manufacture process due to the update of methodology and product design.
(2) Routine intended use of product on the “Catalogue” is changed.
(3) In-vitro diagnostic reagent used by the consumer for self-testing. - Basic requirements
(1) Clinical evaluation of in-vitro diagnostic reagent is performed by the applicants
themselves or is commissioned to the other agency or laboratory. The applicants are
responsible for management of the trial process and authenticity of the data pertaining
to the trial. Overseas applicants can conduct the clinical evaluation through the help of
domestic agent.
(2) The applicants can choose the trial site by themselves according to the product
characteristics. Facilities, equipment and environment of the trial site shall be qualified
to complete the test requirements.
