1. General need to provide: safety risk analysis report (paper and electronic version: 1 original; copy 0; 1. The record materials should be complete, clear, printed and bound on A4 paper, copy Submitted together with the electronic version after stamping the official seal. 2. Product filing information, such as no special instructions, should be signed by the filer. "Seal" means: the filer's seal, or its legal representative, the person in charge of the signature plus corporate seal. The seal must be the official seal of the filer, shall not use the registration seal. 3. Medical devices should be in accordance with YY 0316 "Medical Device Risk Management for Medical Devices" compiled in accordance with the relevant requirements, including the intended use of medical devices and safety-related features of the determination of the hazards, estimate the risk of each hazardous situation; each of the hazards that have been determined to evaluate and decide whether to reduce the risk; risk control measures and implementation of the risk control measures; and the risk control measures and the implementation of the risk control measures. Risk; the implementation of risk control measures and verification results, if necessary, should be quoted from the test and evaluation report; any one or more residual risk acceptability assessment, etc., to form a risk management report. In vitro diagnostic reagents shall form a risk management report on the basis of risk analysis, risk evaluation and corresponding risk control in all aspects of the life cycle of the product, from the determination of the intended use, possible errors in use, safety-related features, known and foreseeable hazards, and the estimation of risks to patients).
2. General need to provide: product technical requirements (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, shall not use the registration seal. 3. Product technical requirements should be prepared in accordance with the "Guiding Principles for the Preparation of Technical Requirements for Medical Device Products").
3. General need to provide: product inspection report (paper and electronic version: 1 original; copy 0; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, shall not be used to register the special seal. 3. Product inspection report shall be the full performance of the product self-inspection report or commissioned inspection report, the test products should be typical.)
4. General need to provide: product specifications and minimum sales unit labeling design samples (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, shall not use the registration seal.3. Medical devices should comply with the "Medical Device Specifications and Labeling Regulations" requirements.4. In vitro diagnostic reagent products should be in accordance with the "Guidelines for the Preparation of In Vitro Diagnostic Reagent Specification" of the relevant requirements and refer to the relevant technical guidelines for the preparation of product specifications.)
5. General need to provide: Class I medical device filing form (electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, and shall not be used to register the special seal. 3. The filing form is filled out completely and in strict accordance with the "Instructions for Filling in the Form" to fill in the form, and at the same time attached to the filing form electronic documents and Excel electronic documents containing the contents of the filing form).
6. General need to provide: Declaration of Conformity (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, shall not use the registration seal. 3.1 Declaration of compliance with the relevant requirements for the filing of medical devices; 3.2 Declaration that the product complies with the first category of medical device product catalog or the corresponding in vitro diagnostic reagents classified subdirectory of the relevant content; 3.3 Declaration that the product complies with the current national standards, industry standards and provide a list of compliance with the standards; 3.4 Declaration of the authenticity of the filing information submitted. )
7. General need to provide: clinical evaluation information (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound on A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, and the registration seal shall not be used. 3.1 Detailed description of the intended use of the product, including the functions provided by the product, and may describe the applicable medical stage (e.g. post-treatment monitoring, rehabilitation, etc.), the target users and their skills/knowledge/training in operating the product; and the devices that are expected to be used in conjunction with it. 3.2 Detailed description of the intended environment of the product, including the location where the product is expected to be used, e.g. hospital, medical/clinical facility, or the place where it is expected to be used. The location where the product is intended to be used, e.g., hospital, medical/clinical laboratory, ambulance, home, etc., and the environmental conditions that may affect its safety and efficacy (e.g., temperature, humidity, power, pressure, mobility, etc.). 3.3 Detailed description of the product's intended user population, including information on the target patient population (e.g., adults, children, or neonates), information on patient selection criteria, and parameters to be monitored and considerations to be taken into account in the use of the product. 3.4 Detailed description of product contraindications, and if applicable, a clear description of the diseases or conditions for which the device is contraindicated.3.5 Comparative description of the clinical use of marketed similar products 3.6. Description of adverse events of similar products).
8. General need to provide: enterprise business license (front and back) (paper: original 0; copy 1; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. (The seal must be the official seal of the filer, shall not use the registered special seal.)
9. General need to provide: a catalog of application materials (paper and electronic version: 1 original; 0 copies; 1. Filing materials should be complete, clear, printed and bound on A4 paper, a copy of the official seal and submit with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, shall not use the registration seal. 3. Information catalog including the entire filing information of the 1-level and 2-level headings, and in tabular form to illustrate the volume and page number of each item.)
10. General need to provide: manufacturing information (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. The seal must be the official seal of the filer, shall not use the registration seal. 3. Overview of 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 outline the main production process, including: the description of the solid phase carrier, color development system, etc. and the 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 outlined.)
11. Generally required: power of attorney (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete, clear, printed and bound using A4 paper, copies stamped with the official seal and submitted together with the electronic version. 2. Product filing information, such as no 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 plus corporate seal. (The seal must be the official seal of the filer, shall not use the registration seal.)
Two, this matter charges:
No charge
Three, processing time limit
1 working days
Four, for the address
Note: If you are domiciled in the administrative region of the government service center or public **** service centers are not in the listed outlets, please first consult the domicile of the Government Service Center or Public **** telephone service center.
Office Name: Nong'an County Government Service Center, 3rd Floor Office Address: 1616 Debiao Street, East of Longfu Square, Nong'an County, Changchun City, Jilin Province, China Office Phone: 0431-83279001 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday-Friday (except legal holidays)
Office Name: Jingyuet Development Zone Government Service Center Branch Address: No. 6666, Eco Street, Jingyue District, Changchun City Branch Tel: 0431-85213531 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Branch Name: Shuangyang District Government Service Center Branch Address: South side of Dinglu Plaza, Shuangyang District, Changchun City Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Jiutai District Government Service Center Office Address: Minsheng Mansion, Jiu Tai District, Changchun City, Jilin Province, Changtong Road and Fulin Street Interchange Office Phone: 0431-81367322 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Yushu Municipal Government Service Center Office Address: Yushu Municipal Government Service Center (Southeast of the Yushu Municipal Government) Office Phone: 0431-83835541 Office Hours: Winter: 8:30-16:00 Summer: 8: 30-16:30 Monday to Friday. 30-16:30 Monday to Friday (except legal holidays)
Office Name: Dewei Municipal Government Service Center Office Address: 100 meters west of the intersection of Dexing Road and Huixin Road in Dewei City Office Phone: 0431-87000815 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Hi-Tech District Government Service Center Office Address: Changchun Hi-Tech District Shuangchuang Center Office Phone: 0431-82532700 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Chaoyang District Government Service Center Office Address: 1149 Yan'an Avenue, Changchun City, China Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Chaoyang District Government Service Center Office Address: 1149 Yan'an Street, Changchun City, China Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) No. 1149 Yan'an Street, Changchun City, Jilin Province Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Erdao District Government Service Center Office Address: No. 799, Huigong Road, at the intersection of Huigong Road and Guangde Street, Erdao District, Changchun City, Jilin Province Office Phone: 0431-89177966 Office Address: No. 799, Huigong Road, at the intersection of Huigong Road and Guangde Street, Changchun City, Jilin Province Office Phone: 0431-89177966 Office Phone: 0431-89177966 Office Phone. 0431-89177966 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Changchun Municipal Government Service Center Office Address: No. 3177, Puyang Street, Changchun City, Changchun City, China Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:00 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:00 00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Nanguan District Government Service Center Office Address: Changchun City, Nanguan District, Jiayuan Road, No. 399, Nanguan Traffic Police east of the office phone: 0431-89682700 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: Nanguan District Government Service Center Office Address: Changchun City, Nanguan District, Jiayuan Road, No. 399, Nanguan Traffic Police East of Office Phone: 0431-89682700 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday ( Legal holidays excepted)
Office Name: Kuancheng District Government Service Center Office Address: No. 228, Fucheng Road, Kuancheng District, Changchun City, Changchun City, China Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (legal holidays excepted)
Office Name: Lianhua Mountain District Government Service Center Service Center Branch Address: Lianhua Mountain Resort Quanyuan Town fog nine Road No. 1 Branch Tel: 0431-81336520 Office Hours: Winter: 9:00-16:30 Summer: 9:00-17:00 Monday to Friday (except legal holidays)
Branch Name: Vehicle opening District Government Service Center Branch Address: Changchun City Vehicle opening District Dongfeng Street No. 7766 Vehicle opening District Management Committee Administrative Committee Branch Tel: 0431-81501237 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Branch Name: Green Park District Government Service Center Branch Address: 6665 Xi'an Road, Changchun City, Jilin Province Branch Tel: 0431-89625000 Office Hours: Winter: 8:30-16:00 Monday to Friday (except legal holidays)
Branch Name: Green Park District Government Service Center Branch Address: 6665 Xi'an Road, Changchun City, Jilin Province Branch Tel: 0431-89625000 Office Hours. Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)
Office Name: 3rd Floor, Nong'an County Government Service Center Office Address: 1616 Debiao Street, East of Nong'an County Longfu Plaza, Changchun City, Jilin Province, Office Phone: 0431-83279001 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday through Friday (except legal holidays)