Basic conditions for applying for the first registration of the second class of in vitro diagnostic reagent products:
1. has been in accordance with the relevant provisions of the business registration of enterprises;
2. has determined to declare the product as the second class of in vitro diagnostic reagents, has been compiled to complete the application for the product product of the product of in vitro diagnostic reagents product technical requirements, and has passed the pre-evaluation;
3. has the production capacity of the product to be registered;
has been established in accordance with the requirements of the Code for Quality Management of Medical Device Manufacturing quality management system for the production of medical devices;
4. for in vitro diagnostic reagent registration application of the personnel have the appropriate professional knowledge, familiar with the rules and regulations of the management of the registration of medical devices and the relevant technical requirements;
5. for the state For products for which the State Food and Drug Administration or the Beijing Food and Drug Administration has issued corresponding technical guidelines or technical review specifications (Link: Review Specifications
), the applicant should refer to the implementation.
The applicant logs on to the Beijing Food and Drug Administration enterprise service platform for online reporting, according to the provisions of the scope of acceptance, the following reporting materials need to be submitted:
1. Application form
(1) should be signed by the legal representative or person in charge and stamped with the official seal;
(2) "Applicant (enterprise name) ", "applicant's residence" and the corresponding content of the industrial and commercial business license;
(3) "product name", "packaging specifications "and the submitted has been pre-evaluation of product technical requirements, test reports and other reporting information in the corresponding content consistent.
2. Supporting documents
(1) a copy of the business license of the enterprise, and should be in effect;
(2) a copy of the organization code certificate, and should be in effect;
(3) in accordance with the special approval process for innovative medical devices within the territory of the second class of in vitro diagnostic reagent products approved by the approval of the procedure to apply for registration of samples entrusted to the production of other enterprises The production license of the entrusted enterprise production scope should cover the declared products.
3. Summary information
(1) the intended use of the product
the intended use of the product, the intended use of the clinical indications related to the background, such as the incidence of clinical indications, susceptible populations, etc., the relevant clinical or laboratory diagnostic methods, etc.
(2) the product description
including the technical principles adopted by the product, the main sources of raw materials and methods of preparation, the product's quality and safety. source of raw materials and preparation methods, the main production process, quality control products, standards (calibration products) preparation methods and traceability.
(3) Explanation of biological safety
Since the main raw materials in the in vitro diagnostic reagents may be prepared by various animals, pathogens, human tissues and body fluids and other biological materials through the treatment or addition of certain substances, the human source materials must be explained on the infectious diseases (HIV, HBV, HCV, etc.), and to provide the relevant supporting documents. Other materials of animal origin and microbial origin, should provide the appropriate documents to prove that it is safe for the user and the environment in the product transportation, use, and the above raw materials used in the inactivation and other test methods to be explained.
(4) the summary and evaluation of the main findings of the product concerned.
(5) Other
Including similar products approved for marketing at home and abroad. The technical methods and clinical application of the product concerned, the similarities and differences between the product applied for registration and similar products at home and abroad. For new diagnostic reagent products, it is necessary to provide literature on the relationship between the measured substance and the expected applicable clinical indications.
4. Analytical performance assessment information
(1) in vitro diagnostic reagents, analytical performance assessment mainly includes precision, accuracy, sensitivity, specificity, linear range or measurement range and other items. Performance evaluation should be carried out on multiple batches of products, and the results should be statistically analyzed in order to effectively control the stability of the product production process and product quality.
If the application for registration includes different applicable models, it is necessary to submit test data and summaries of the evaluation of the above items on different models.
If the application for registration includes different packaging specifications, the differences between the different packaging specifications need to be analyzed or verified. If there are differences in performance between products of different packaging specifications, it is necessary to submit the test data and summary of the evaluation of the above items using the products of each packaging specification. If there is no difference in performance between different packaging specifications, it is necessary to submit a detailed description of the non-existence of differences in performance between packaging specifications, specifying the differences between different packaging specifications and the possible impact.
(2) Calibration products should be submitted to the complete traceability documents.
(3) Quality control products should be submitted in all applicable models of the calibration information.
5. Positive judgment value or reference interval determination information
Should be a detailed description of the positive judgment value or reference interval determination of the method or basis for the determination of the positive judgment value or reference interval to determine the source of the samples used to determine the value of the positive judgment or reference interval, and to provide a positive judgment value or reference interval determination of the detailed test information and summary.
Calibrators and quality control products are not required to submit the positive judgment value or reference interval determination information.
6. Stability study information
Including at least three batches of samples in the actual storage conditions preserved until after the expiration date of the finished product of the real-time stability study information, and should take into account the product in the process of storage, transportation, use of unfavorable conditions, and the corresponding stability study. Should be detailed description of the stability study method of determining the basis and specific test methods, processes.
7. Production and self-inspection records
Provide three consecutive batches of product production and self-inspection record copies.
8. Clinical evaluation data
Including the corresponding clinical trial data and/or non-clinical evaluation data.
(1) clinical trials
The need for clinical trials of in vitro diagnostic reagents, the applicant should refer to the relevant technical guidelines to carry out clinical trials, and provide the following clinical trial information:
a. Ethics Committee agreed to the clinical trials carried out in writing.
b.Clinical trial protocol: signed by each principal investigator undertaking the clinical trial, stamped by the clinical trial organization, signed by the person in charge of statistics and stamped by the unit, and stamped by the applicant.
c. Clinical trial report of each clinical trial organization: the trial report of each clinical trial organization shall be signed by the clinical trial organization; the cover of the report includes the common name of the in vitro diagnostic reagent for the test, the date of the start of the test, the date of the completion of the test, the principal investigator (signature), the trial organization (seal), the signature of the person in charge of statistics and the unit (seal), the applicant (seal), the applicant's contact person and contact information, date of report, location of preservation of original data.
d. Summary report on the results of all clinical trials: the summary report is completed by the lead unit of the clinical trial organization or the applicant, and the cover content is the same as the cover content of the clinical trial report of each clinical trial organization.
e. Annexes to the clinical trial report: details of the clinical trial, including other test methods used in the clinical trial or other diagnostic reagent products, such as test methods, diagnostic reagents, product source, product specifications and registration approval, all test data in the clinical trial (to be signed by the operator of the clinical trial, the reviewer, and stamped by the clinical trial organization), the main references, the principal investigator's resume, and other information that the applicant needs to explain.
(2) Products in the catalog of in vitro diagnostic reagents exempted from clinical trials issued by the State Food and Drug Administration shall be submitted with corresponding clinical evaluation data.
Based on the corresponding guidelines (if any), the evaluation information on the clinical performance of the in vitro diagnostic reagent through the assessment of clinical samples covering the intended use and interfering factors, the synthesis of the literature, clinical experience data and other data on the safety and efficacy of the product, as well as information on the source of the clinical samples used.
(3) Calibration and quality control products are not required to provide clinical trial information.
(4) The seal of the clinical trial organization referred to in this part means the official seal of the clinical trial organization.
9. Product risk analysis information
In vitro diagnostic reagents on all aspects of the life cycle of the product, from the intended use, possible errors in use, safety-related features, known and foreseeable hazards and other aspects of the determination and estimation of patient risk risk risk analysis, risk evaluation and risk control based on the formation of risk management report. Risk management information is the product's risk management process and the results of the review to be documented to form the information. Risk management information should be provided for each identified hazards of the following processes of traceability:
(1) the in vitro diagnostic reagent product life cycle of each link, from the intended use, possible errors in use, safety-related features, known and foreseeable hazards and other aspects of the determination and estimation of the risk to the patient;
(2) Risk Evaluation: each identified hazard situation, evaluation and decide whether or not the risk analysis and risk control report. hazardous situation, evaluation and decision on the need for risk reduction;
(3) results of the implementation and validation of risk control measures, citing testing and evaluative reports where necessary;
(4) acceptability ratings of any one or more of the residual risks;
(5) shall be in accordance with the requirements of relevant industry standards.
10. Product Technical Requirements
Medical device product technical requirements should be prepared in accordance with the provisions of the "Guidelines for the Preparation of Technical Requirements for Medical Device Products". The content should contain product performance requirements, test methods, as well as the main raw materials, production processes and semi-finished products of the technical requirements. Product technical requirements need to pass the pre-evaluation, the declaration of registration should be submitted to two, and at the same time, submit two paper consistency and consistency with the content of the product technical requirements of the online fill in the statement.
The applicant should be in the raw material quality and production process under the premise of stability, according to the applicant's product development, preclinical evaluation and other results, based on national standards, industry standards and relevant literature, in accordance with the "Guiding Principles for the Preparation of Technical Requirements for Medical Devices Products," the relevant requirements, the preparation of technical requirements for the product. Mainly contains product performance indicators and test methods.
11. Product registration inspection report
Provide the corresponding medical device inspection qualification of medical device inspection organizations issued by the registration inspection report and product technical requirements of the pre-evaluation. There are national standards, reference products, products should use national standards, reference products for registration inspection, and meet the relevant requirements.
12. Product specifications
The applicant should be in accordance with the "in vitro diagnostic reagents instructions for the preparation of the relevant requirements of the Guidelines" and refer to the relevant technical guidelines for the preparation of product specifications.
In accordance with the guidelines for the preparation of product specifications should be submitted in duplicate, and submit two copies of the product specification text is identical to the statement.
13. Sample labels
Should be consistent with the "medical device instructions and labeling regulations" requirements.
The label on the product packaging must include the product's common name, the applicant's name, production address, product lot number, precautions, storage conditions and expiration date.
For in vitro diagnostic reagent products in various components such as calibrators, quality control products, cleaning fluids, etc., its labeling must be marked with the component's Chinese name and batch number. As the batch number of products, different batch numbers of the various components can not be replaced, it is necessary to indicate both the product batch number, but also to indicate the batch number of the various components.
14. Declaration of Conformity
Declaration of conformity shall be signed by the legal representative or person in charge and stamped with the official seal of the enterprise, and include the following:
(1) The applicant declares that the product complies with the relevant requirements of the "Measures for the Administration of In Vitro Diagnostic Reagents"; declares that the product conforms to the principle of the "Measures for the Administration of In Vitro Diagnostic Reagents" on the product categorization and the relevant classification requirements of the "Classification Sub-catalog of In Vitro Diagnostic Reagents Classification Subdirectory" on the classification requirements; declare that the product complies with the current national standards, industry standards, and provide a list of standards;
(2) the applicant to submit information on the authenticity of the self-assurance statement, and to make the material if false commitment to bear legal responsibility.
15. Submission of electronic documents for registration application information, at least should include:
Review information, research data summary and in vitro diagnostic reagent product specification: should be a word document (provided in the form of uploaded attachments).
16. Declaration of information, not the legal representative or person in charge himself, should be submitted to the "power of attorney".
17. Submit a declaration of information catalog. Registration of information should be submitted to the directory of information, including the declaration of information on the first and second level headings. Each secondary title corresponding to the information should be prepared separately page number.
Standards:
1. The declaration information should be true, complete, clear, neat, stamped with the official seal of the enterprise, the signature required to sign;
2. Applicants to fill in the form and preparation of the declaration information should be A4-size paper, the original documents issued by the government and other agencies in accordance with the original size of the provision of the original size;
3. All declarations should be submitted to the photocopy Where the declaration of information should be submitted copies, the copies should be clear, and should be dated on the copies, stamped with the official seal of the enterprise;
4. Declaration of information on the left margin should generally be greater than 20mm (for file binding), each copy of the material needs to be bound into a book;
5. Declaration of information on the same project should be filled out consistently;
6. Declaration of information on the form of review, to ensure that the declaration of information on the completeness of the information, Clear, accurate and consistent, the accepted products should be announced online.
7.