The published the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents Listed in Catalog of Clinical Trial Exemption” and “Clinical Guideline for In Vitro Diagnostic Reagents” on September 24 and September 27, respectively.
For IVDs Exempted from Clinical Trial
The applicant going through clinical evaluation should prove the reagents are substantially equivalent to the already marketed products in China, or the test results of the reference measurement procedures/diagnostic accuracy standards are consistent.
Applicants should use the final finalized reagents for clinical evaluation. Before clinical evaluation, the basic performance of the product should be determined, usually including the applicable sample type, specificity, precision, detection limit and/or quantification limit, measurement interval, positive judgment value, reference interval, etc.
If the clinical evaluation fails to prove that the reagent to be evaluated is substantially equivalent to the domestic marketed product, or the consistency with the reference measurement procedure/diagnostic accuracy standard test result are not well demonstrated, the reagent should be evaluated through clinical trials.
Requirements for Clinical Evaluation
- The document details the following three requirements:
- Methodological comparison study of the same species
- Comparative research with reference measurement procedures or diagnostic accuracy standards
- Methodological comparison research related to changes
Clinical Evaluation Report Requirements
- Descriptive comparative analysis
- Comparing performance data
The document includes “Comparison Analysis Items of Applied Reagents and Contrast Reagents” as annex.
For IVDs undergoing Clinical Trial
Clinical trials should follow the ethical guidelines of the “World Medical Congress Declaration of Helsinki” and relevant national requirements for biomedical research ethics involving humans, and should be reviewed and approved by the ethics committee.
When collecting blood, urine, sputum, cerebrospinal fluid, feces, vaginal secretions, nasopharyngeal swabs, tissue sections, bone marrow, amniotic fluid, etc., the clinical protocols need to be reviewed by the ethics committee.
The pre-clinical research should have sufficient scientific basis and clear trial objectives. The clinical trials should be designed based on the intended use, the epidemiological background and statistical requirements, while the trial errors should be controlled to the greatest extent, the quality of the trials should be improved, and the results of the trials should be reasonably analyzed.
The principle of law
This guideline is formulated under the direction of “Regulations on the Supervision and Administration of Medical Devices” (Order No. 739 of the State Council), the “Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents” (Order No. 48 of the State Administration for Market Regulation) and the “Standards for Quality Management of Medical Device Clinical Trials”.
Clinical Trial Design
- Design type
- Subject selection and sample collection
- Number and requirements of clinical trial institutions
- Clinical evaluation index
- Statistical analysis of clinical trials
- Sample size requirements
- Control of Bias
- Other factors that need to be considered in the design of clinical trials
The document also details the clinical trial quality management requirements and includes “Examples of Sample Size Estimation Methods” as annex.