1. General requirements include: safety risk analysis report (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. Medical devices should be compiled according to the relevant requirements of YY 03 16 "Application of Medical Device Risk Management in Medical Devices", which mainly includes the judgment of the expected use and safety-related characteristics of medical devices, the judgment of hazards and the risk estimation under various hazards; Evaluate and decide whether it is necessary to reduce the risk for each judged dangerous situation; The implementation and verification results of risk control measures, and the inspection and evaluation report should be cited when necessary; Acceptability assessment of any one or more residual risks, etc. And form a risk management report. In vitro diagnostic reagents should deal with all aspects of the product life cycle, and form a risk management report based on the judgment of expected use, possible use errors, safety-related characteristics, known and foreseeable hazards, as well as risk analysis, risk assessment and corresponding risk control of patient risk estimation. )
2. General requirements: product technical requirements (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. The product technical requirements shall be compiled in accordance with the Guiding Principles for the Compilation of Technical Requirements for Medical Devices. )
3. General requirements: product inspection report (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. The product inspection report shall be a full-performance self-inspection report or an entrusted inspection report, and the inspected products shall be representative. )
4. Generally, it is required to provide: product manual and minimum sales unit label design sample (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. Medical devices shall meet the requirements of the Regulations on the Management of Instructions and Labels of Medical Devices. 4. In-vitro diagnostic reagent products should be prepared in accordance with the relevant requirements of the Guidelines for Preparation of Instructions for In-vitro Diagnostic Reagents and with reference to relevant technical guidelines. )
5. Generally, it is required to provide: the filing form for Class I medical devices (electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. Complete the filing form, fill in it in strict accordance with the instructions, and attach the filing form electronic document and Excel electronic document containing the contents of the filing form). )
6. General requirements: declaration of conformity (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. 1 declares that it meets the relevant requirements for medical device filing; 3.2 Declare that the product conforms to the relevant contents of Category I medical device product catalogue or the corresponding in-vitro diagnostic reagent classification subdirectory; 3.3 declare that the product conforms to the current national standards and industry standards, and provide a list of standards; 3.4. Declare the authenticity of the filing materials submitted. )
7. General requirements: clinical evaluation materials (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. 1 explain in detail the intended use of the product, including the functions provided by the product, and describe the applicable medical stages (such as post-treatment monitoring and rehabilitation, etc.). ), target users and their skills/knowledge/training in operating products; The device to be combined with. 3.2 Detail the expected use environment of the product, including the expected use place of the product, such as hospitals, medical/clinical laboratories, ambulances, families, etc. And environmental conditions (such as temperature, humidity, power, pressure, movement, etc.) that may affect its safety and effectiveness. ) .3.3 Describe in detail the applicable population of the product, including the information of the target patient population (such as adults, children or newborns), the information of patient selection criteria, and the parameters to be monitored and the factors to be considered in the use process. 3.4 Describe the contraindications of the product in detail, and if applicable, clearly state the diseases or conditions in which the device is prohibited. 3.5 Comparison of clinical use of similar products in the market 3.6. Description of adverse events of similar products. )
8. General requirements: enterprise business license (original and photocopy) (paper: 0 original; 1 serving; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. )
9. General requirements: List of application materials (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. The information catalogue includes 1 and 2 titles of the whole application materials, and shows the number of volumes and page numbers of each item in tabular form. )
10. General requirements: manufacturing information (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. 3. Overview of production process. Passive medical devices should explain the production and processing technology of the products, and indicate the key technologies and special technologies. Active medical devices should provide descriptive information about the production process of products, which can be in the form of flow charts and an overview of the production process. The main production processes of in vitro diagnostic reagents should be summarized, including the description and determination basis of solid phase carrier and chromogenic system. The reaction system includes sample collection and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration methods (if necessary) and quality control methods. The actual situation of R&D and production site should be summarized. )
1 1. Generally, you need to provide: power of attorney (paper and electronic version: 1 original; 0 copies; 1. The filing materials shall be complete and clear, printed and bound on A4 paper, and the copies shall be submitted together with the electronic version after being stamped with the official seal. 2. If there is no special explanation in the product filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the applicant, or the signature of its legal representative and responsible person plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for filing is not allowed. )
Two. Allegations on this matter:
be free of charge
Third, the processing time limit
1 working day
Four. Processing address
Note: If the government service center or public service center in the administrative area where your household registration is located is not in the listed outlets, please call the government service center or public service center where your household registration is located first.
Name of outlet: 3rd floor, Government Affairs Service Center, Nong 'an County, Changchun City, Jilin Province Address: Debiao Street 16 16 East of Long Fu Square, Nong 'an County, Changchun City, Jilin Province Tel: 043 1-8327900 1 Office hours: 8: 30-/kloc-0 in winter.
Name of outlet: Government Affairs Service Center of Jingyue Development Zone Address: No.6666, Ecological Street, Jingyue District, Changchun City Tel: 0431-85213531Office hours: 8: 30 in winter-0/6: 00 in summer: 8: 30-65438.
Network Name: Shuangyang District Government Affairs Service Center Network Address: South of Dinglu Square, Shuangyang District, Changchun City Tel: 043 1-84285756 Office hours: 8: 30 in winter-16: 00 in summer-16: 30 (except legal holidays).
Network Name: Jiutai District Government Affairs Service Center Network Address: Minsheng Building at the intersection of Changdao Road and Fulin Street in Jiutai, Changchun, Jilin Province Network Tel: 043 1-8 1367322 Office hours: 8: 30 in winter-16: 00 in summer-8: 30-/kloc-0.
Network Name: Yushu Municipal Affairs Service Center Network Address: Yushu Municipal Affairs Service Center (southeast of Yushu Municipal Government) Network Tel: 043 1-838354 1 Office hours: 8: 30-16: 00: 8: 30-16 in winter.
Name of outlet: dehui city Municipal Affairs Service Center outlet address: west of the intersection of Dexing Road and Huixin Road in dehui city 100m Tel: 043 1-870008 15 Office hours: 8: 30 in winter-0/6: 00 in summer-8: 30-/KLOC-0.
Name of outlet: Administrative Service Center of High-tech Zone Address: Shuangchuang Center of Changchun High-tech Zone Tel: 043 1-82532700 Office hours: 8: 30 in winter-16: 00 in summer-8:30- 16:30 (except legal holidays).
Network name: Chaoyang District Government Affairs Service Center Network address: Yan 'an Street, Changchun City, Jilin Province 1 149 Internet phone: 043 1-850907 18 Office hours: 8: 30 in winter:16: 00 in summer: 8: 00.
Network name: Erdao District Government Affairs Service Center Network address: No.799, Gong Hui Road, intersection of Gong Hui Road and Guangde Street, Erdao District, Changchun; Internet phone: 043 1-89 177966 Office hours: 8: 30 in winter-16: 00 in summer-/kloc-0.
Name of outlet: Changchun Municipal Affairs Service Center outlet Address: No.3177, Puyang Street, Changchun City Tel: 043 1-887790 17 Office hours: 8: 30 in winter-0/6: 00 in summer-8: 30-/KLOC-0.
Network name: Nanguan District Government Affairs Service Center Network address: No.399 Jiayuan Road, Nanguan District, Changchun City East Network Tel: 043 1-89682700 Office hours: 8:30- 16:00 in winter: 8:30- 16:30 in summer.
Network Name: Kuancheng District Government Affairs Service Center Network Address: No.228 Fucheng Road, Kuancheng District, Changchun City Tel: 043 1-8999 1639 Office hours: 8: 30 in winter-16: 00 in summer-16.
Name of outlet: Lianhuashan Government Service Center outlet Address: Wujiu Road, Yan Quan Town, Lianhuashan Resort 1No. Tel: 043 1-8 1336520 Office hours: 9: 00 in winter-0/6: 30 in summer-9: 00-/KLOC.
Name of outlet: administrative service center of Cage District Address: No.7766, Dongfeng Street, Cage District, Changchun City Tel: 0431-8150/237 Office hours: 8: 30 in winter-0/6: 00 in summer: 8: 30-6547.
Network Name: Government Affairs Service Center of Lvyuan District Network Address: No.6665, Xi 'an Road, Changchun City, Jilin Province Tel: 043 1-89625000 Office hours: 8: 30 in winter-16: 00 in summer-16: 30 (except legal holidays)
Name of outlet: 3rd floor, Government Affairs Service Center, Nong 'an County, Changchun City, Jilin Province Address: Debiao Street 16 16 East of Long Fu Square, Nong 'an County, Changchun City, Jilin Province Tel: 043 1-8327900 1 Office hours: 8: 30-/kloc-0 in winter.