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CFDA publishes the guideline on technical evaluation for ER and PR antibody reagent and assay kits

from CIRS by
17th April 2015, CFDA issued the notice on the guideline on technical evaluation for ER and PR antibody reagent and assay kits (notice No.11-2015). It is helpful for ER&PR registrant to prepare the dossier and it will be a standardized principle for registration evaluation.
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
The applicants are recommended to explain the general information of the product based on the following aspects:
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 applicant shall submit all the research documents for the product performance verification at the product development stage or finished verification stage, including the specific method, quality standard, test data, statistical analysis and other details. For this kind of products research focuses on analyzing the following properties: (1) Immunoreactivity; (2) Precision; (3) Sensitivity; (4) Quality control activities about participating in the domestic and overseas quality control institutions;
  • The Positive Predictive Value
The documents include the related documents on latest domestic and international guideline, and dyeing characteristics.

  • The Stability Study
The documents of stability study mainly involve two parts: the stability of reagent and the stability of sample.

  • Clinic trial

1. The test method;
2. The screening of the clinical study site;

The applicants shall choose not less than three (3) clinical study sites to conduct clinical trial and they should approved by CFDA.

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
The documents of product technical requirements should be prepared according the “Guideline on Medical Device Technical Requirements Preparation” (CFDA notice No. 9-2014), there are including the product performances: appearance, conformity, intra repeatability, inter reproducibility, stability, etc.
  • Testing in Qualified Laboratory
There are required three consecutive batches samples testing in testing institution approved by CFDA for initial registration.

  • The Product Instructions
The important content of the product instructions should contains intended use, testing principle, main constituents, storage conditions & shelf life, sample requirements, test method, positive predictive value( if applicable), the interpretation of the test results, the limitations of test method, product performance and matters need attention.

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.

  

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+86 571 8720 6559 (GMT+8 8:30~17:00)