Class I medical device filing information requirements and instructions
I, filing information
(a) Class I medical device filing form
(b) Safety Risk Analysis Report
Medical devices should be prepared in accordance with the relevant requirements of the YY 0316 "Risk Management of Medical Devices Application of medical devices" of the relevant requirements of the preparation, mainly including the intended use of medical devices and safety-related features of the determination, the determination of hazards, estimation of the risk of each hazardous situation; for each of the determined hazardous situation, evaluation and decision on the need to reduce the risk; the implementation of risk control measures and validation of the results, if necessary, should be cited as a test and evaluative reports; any one or more residual risk of the acceptability ratings, etc., to form a risk management report.
In vitro diagnostic reagents should be used in all aspects of the product life cycle, 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.
(C) product technical requirements
Product technical requirements should be prepared in accordance with the "Guidelines for the Preparation of Technical Requirements for Medical Device Products".
(D) product inspection report
Product inspection report should be the full performance of the product self-inspection report or commissioned inspection report, the inspection of the product should be typical.
(V) Clinical evaluation information
1. Detailed description of the intended use of the product, including the functions provided by the product, and can describe the applicable medical stage (such as post-treatment monitoring, rehabilitation, etc.), the target user and their operation of the product should have the skills/knowledge/training; expected to be used in combination with its devices.
2. A detailed description of the environment in which the product is intended to be used, including the location in which the product is intended to be used such as hospitals, medical/clinical laboratories, ambulances, homes, etc., and the environmental conditions (e.g., temperature, humidity, power, pressure, mobility, etc.) that may affect its safety and effectiveness.
3. A detailed description of the population for which the product is intended, including information on the target patient population (e.g., adults, children, or neonates), information on patient selection criteria, and parameters to be monitored, and factors to be considered during use.
4. Detailed description of product contraindications and, if applicable, a clear description of the diseases or conditions for which the device is contraindicated.
5. Comparative description of the clinical use of similar products already on the market.
6. Adverse events of similar products.
(F) product specifications and minimum sales unit labeling design samples
Medical devices should be consistent with the corresponding regulations. Imported medical device products should be submitted to the competent government departments outside the approval or recognition of the original manual and its Chinese translation.
In vitro diagnostic reagent products should be in accordance with the "in vitro diagnostic reagent instructions to prepare the relevant requirements of the Guiding Principles", and reference to the relevant technical guidelines for the preparation of product specifications. Imported in vitro diagnostic reagent products should be submitted to the competent authorities outside the government approved or recognized the original manual and its Chinese translation.
(VII) manufacturing information
Overview of the situation related to the production process. Passive medical devices should be clear product production and processing technology, indicating the key processes and special processes. Active medical devices should provide descriptive information on the product production process, can be in the form of flow charts, is an overview of the production process. In vitro diagnostic reagents should be an overview of the main production process, including: description of the solid phase carrier, color development system and other basis for determining the reaction system including sample collection and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration methods (if necessary), quality control methods.
The actual situation of the development and production site should be summarized.
(viii) Supporting documents
1. Domestic filers provide: a copy of the business license of the enterprise, a copy of the organization code certificate.
2. Overseas filers to provide:
(1) Overseas filers enterprise qualification documents.
(2) overseas filers registered or production address of the country (region) where the competent medical device authorities to allow the product marketing documents. The filer's place of registration or production address in the country (region) is not the product as a medical device management, the filer is required to provide relevant documents, including the filer's place of registration or production address in the country (region) to allow the product to legally marketed and sold documents. If the documents are copies, they should be notarized by the local notary public.
(3) overseas filers in China to designate the agent's power of attorney, the agent's letter of commitment and a copy of the business license or a copy of the agency registration certificate.
(IX) Declaration of Conformity
1. Declaration of conformity with the relevant requirements for the filing of medical devices;
2. Declaration of conformity with the product catalog of Class I medical devices or the corresponding in vitro diagnostic reagents classified subdirectory of the relevant content;
3. Declaration of conformity with the product with the current national standards, industry standards and to provide a list of conformity standards;
4. Declare the authenticity of the information submitted for the record.
Second, change the filing information
(a) changes in the description of the situation and the relevant documents
Changes in the description of the situation should be attached to the filing of information on the table changes in the content of the comparative list.
Relating to changes in product technical requirements, product technical requirements should be provided to change the content of the comparison table.
Change of product name (in vitro diagnostic reagents for the product classification name, the same hereinafter), product description, intended use, the content of the change should be consistent with the first class of medical devices catalog and the corresponding in vitro diagnostic reagents subdirectory corresponding content. Among them, the product name should be the same as those listed in the catalog; product description, intended use, should be the same as those listed in the catalog or less than the catalog content.
The corresponding supporting documents should be detailed, comprehensive and accurate.
(B) supporting documents
1. Domestic filers to provide: a copy of the business license copy, a copy of the organization code certificate.
2. Overseas filers to provide:
(1) such as changes in the overseas filers registered or production address in the country (region) should be allowed to obtain a new medical device competent authorities to allow the product marketing documents issued by the marketing documents should be submitted to the new listing documents. If the document is a copy, should be notarized by the local notary public.
(2) the overseas filer in China to designate the agent's power of attorney, the agent's letter of commitment and a copy of the business license or a copy of the agency registration certificate.
(C) Declaration of Conformity
1. Declaration of conformity with the relevant requirements for the filing of medical devices;
2. Declaration of conformity with the product catalog of Class I medical devices and the corresponding in vitro diagnostic reagents classified subdirectory of the relevant content;
3. Declaration of conformity with the product with the current national standards, industry standards and to provide a list of conformity standards;
4. Declare the authenticity of the submitted filing information.
Attachment: filing information form requirements
Attachment
Filing information form requirements
I. Filing information is complete and ready. The filing form is filled out completely.
Two, in addition to the supporting documents should be provided in Chinese form. If the supporting documents for the form of foreign language should also provide a Chinese translation. Translation of the declaration based on foreign language information should be provided at the same time the original text.
Three, the domestic product record information without special instructions, should be signed by the filer. "Signature" means: the filer's seal, or its legal representative, the person in charge of the signature and corporate seal. The seal must be the official seal of the filer, shall not be used to register the special seal.
Four, imported products for the record without special instructions, the original information should be the original, and signed by the filer, the Chinese text signed by the agent. Original information "signature" means: the legal representative of the filer, the person in charge of the signature, or signature and organization seal, and should be submitted by the filer of the notary public agency issued by the location of the notarization; Chinese information "signature" means: the agent of the organization Seal, or its legal representative, the person in charge of the signature and organization seal.
V. The filing information should be submitted to the directory, including the entire filing information of the level 1 and 2 headings, and in the form of a table describing the volume and page number of each item.