This guideline describes the scope, data requirements, documentation template with some practical advices and how to prepare the registration materials. It enable registrant to proceed with the initial registration or certificate update, the product risk assessment and some other not mentioned in this guideline should be complied with the relevant CFDA regulations, e.g. “Administrative Measures for the Registration of In Vitro Diagnostic Reagents” (CFDA order No. 5).
Scope
Estrogen Receptor (ER) and Progesterone Receptor (PR) antibody reagent and assay kits refer to the use of the immunohistochemical method, detect the ER and PR on the pathological sections. There are two kinds of ER subtype, respectively is ERα and ERβ, but this guideline mentions ER as ERα.
Data Requirements
- General Documents
1. Biological characteristics;
2. Tissue distribution and function;
3. Relationship between disease and therapy;
4. Comparing the similarities and differences with the similar product in domestic and overseas.
- R&D Documents for its Raw Material
1. Describe the clinical significance of ER/PR detection;
2. The detailed research documents of the first antibody;
3. The selection and verification documents of the enzyme-labeled second antibody system( if applicable);
4. The research documents of internal quality control piece and kit quality control piece( if applicable);
5. The research documents of sealing liquid;
6. The selection and verification of other major original raw materials, such as bovine serum albumin, antigen repair liquid, antibacterial agent, etc.
- Main Production Process and Reaction System
1. Description of the main production process;
2. The detailed research documents of the first antibody preparation (if applicable);
3. Introduction of product basic reaction principle;
4. The detailed principle of antigen repairing method determination;
5. Research records on the determination of the optional antibody titers and antibody incubation time;
6. Research records on the determination of reaction conditions of the detection system;
- The Evaluation Documents of Assay Performance
- The Positive Predictive Value
- The Stability Study
- Clinic trial
1. The test method;
2. The screening of the clinical study site;
3. The clinical trial protocol;
4. Case selection and sample types (Sample size: 1000).
5. Statistical analysis;
6. The verification of results difference between samples;
7. Quality control
8. The original data;
9. Final report: Clinical Trial Report.
- The Product Technical Requirements
- Testing in Qualified Laboratory
- The Product Instructions
Conclusions and Advices
CFDA will issue the guideline on technical evaluation for medical devices or in vitro diagnostic regent. it will be a good supportive guidance for registrant, CIRS has gathered the all CFDA guidelines and transferred into the practical registration procedure, if you hope to get it, please contact us for more detailed information.