1. In Changchun, the following materials are required to apply for the "change of the production record of Class I medical devices": 1. Generally, it is required to provide: the change form of the production record of Class I medical devices (electronic version: 1 original; copies; 1. Fill in the filing form completely and in strict accordance with the Instructions for Filling in the Form, and attach the electronic document of the filing form at the same time. ) 2. Generally, it is required to provide: the first type of medical device production record certificate (paper: 1 original; 1 copy; Must be signed by the filer. 3. Generally, it is required to provide: the identity certificate of the legal representative and the identity certificate of the person in charge of the enterprise (paper: originals; 1 copy; Must be signed by the filer. 4. Generally, it is required to provide: the certificate of authorization of the manager (paper and electronic version: 1 original; copies; The signature of the record holder and the signature of the legal representative (or private seal) must be filed. 5. Generally, it is required to provide: a catalogue of application materials (paper and electronic version: 1 original; 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 for the filing materials, it shall be signed and sealed by the filing person. "Signature" refers to the seal of the filer, or the signature of its legal representative and person in charge plus the seal of the enterprise. The seal must be the official seal of the filer, and the special seal for registration is not allowed. 3. The information catalogue includes the first-level and second-level titles of the entire application materials, and the volume and page number of each item are indicated in tabular form. 6. Generally, it is required to provide: a self-assurance statement of the authenticity of the application materials (paper and electronic version: originals; 1 copy; Must be signed by the filer. Including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood. ) 7. Generally, it is required to provide: certification documents of the production site (paper: originals; 1 copy; Must be signed by the filer. (If there are special production environment requirements, the supporting documents of facilities and environment shall also be submitted). ) 8. Generally, it is required to provide: the first-class medical device production record certificate of the trustee (paper: originals; 1 copy; Must be signed by the filer. ) 9. Generally, it is required to provide: the original and duplicate of the business license of the trustee (paper: originals; 1 copy; Must be signed by the filer. ) 1. Generally, it is required to provide: the self-assurance statement of the entrusting party on the quality, sales and after-sales service responsibilities of the commissioned medical devices (paper and electronic version: originals; 1 copy; Must be signed by the filer. ) 11. Generally, it is required to provide: the entrusting party's medical device entrusted production record certificate (paper: originals; 1 copy; Must be signed by the filer. ) 12. Generally, it is required to provide: commissioned production contract (paper and electronic version: originals; 1 copy; Must be signed by the filer. ) 13. Generally, it is required to provide: the original and duplicate of the changed business license (paper: originals; 1 copy; Must be signed by the filer. ) 14. Generally, it is required to provide: the original copy of the changed organization code certificate (paper: originals; 1 copy; Must be signed by the filer. ) 15. Generally, it is required to provide: the Record Certificate of Class I Medical Devices for the production of products (paper: originals; 1 copy; Must be signed by the filer. ) 16. Generally, it is required to provide: increase the product technical requirements for the production of products (paper and electronic versions: originals; 1 copy; Must be signed by the filer. ) 17. Generally, it is required to provide: notice of approval of change registration (filing) (paper: originals; 1 copy; Must be signed by the filer. ) II. Charges for this matter: No charge. III. Processing time limit is 1 working day. IV. Handling 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 of your household registration first. Name of outlet: 3rd floor, Nongan County Government Affairs Service Center Address: No.1616 Debiao Street, east of Longfu Square, Nongan County, Changchun City, Jilin Province Tel: 431-832791 Office hours: 8:3-16: in winter: 8:3-16:3 in summer (except legal holidays) Outlet name: Jingyue Development Zone Government Affairs Service Center outlet. No.6666, Ecological Street, Yuequ Tel: 431-85213531 Office hours: 8:3-16: in winter: 8:3-16:3 in summer Monday to Friday (except legal holidays) Name of outlet: Shuangyang District Government Affairs Service Center Address: South outlet of Dinglu Square, Shuangyang District, Changchun Tel: 431-8421. Winter: 8:3-16: Summer: 8:3-16:3 Monday-Friday (except statutory holidays) Network Name: dehui city Municipal Affairs Service Center Network Address: 1m westbound at the intersection of Dexing Road and Huixin Road in dehui city Network Tel: 431-87815 Office Hours: Winter: 8:3-16: Summer. Except statutory holidays) outlet name: yushu city Municipal Affairs Service Center outlet address: yushu city Municipal Affairs Service Center (southeast of yushu city Municipal Government) outlet Tel: 431-83835541 Office hours: 8:3-16: in winter: 8:3-16:3 in summer (except statutory holidays) outlet name: Jiutai District Administrative Service Center outlet address: Minsheng Building outlet at the intersection of Jiutai District Mayor's Access Road and Fulin Street Tel: 431-81367322 Office hours: 8:3-16: in winter: 8:3-16:3 in summer (except legal holidays) Outlet name: Chaoyang District Government Affairs Service Center outlet address: No.1149 Yan 'an Street, Changchun City, Jilin Province Tel: 431- 8 Office hours: Winter: 8:3-16: Summer: 8:3-16:3 Monday to Friday (except statutory holidays) Network name: Network address of government service center of high-tech zone: Network address of Shuangchuang Center of Changchun High-tech zone Tel: 431-825327 Office hours: Winter: 8:3-16: Summer. (except statutory holidays) outlet name: Erdao District Government Service Center outlet address: No.799, Huigong Road, intersection of Huigong Road and Guangde Street, Erdao District, Changchun Tel: 431-89177966 Office hours: 8:3-16: in winter: 8:3-16:3 in summer (except statutory holidays) outlet name: Changchun. : No.3177 Puyang Street, Changchun Tel: 431-8877917 Office Hours: Winter: 8:3-16: Summer: 8:3-16:3 Monday to Friday (except legal holidays) Name of outlet: Nanguan District Government Service Center Address: East outlet of Nanguan Traffic Police Force, No.399 Jiayuan Road, Nanguan District, Changchun Tel: 4 Office hours: 8:3-16: in winter; 8:3-16:3 in summer; Monday to Friday (except statutory holidays); outlet name: Kuancheng District Government Service Center outlet address: No.228 Fucheng Road, Kuancheng District, Changchun City Tel: 431-89991639 Office hours: 8: 3-16 in winter. Friday (except statutory holidays) outlet name: Lianhua Mountain Government Affairs Service Center outlet address: No.1 Wujiu Road, Quanyan Town, Lianhuashan Resort Tel: 431-8133652 Office hours: winter: 9:-16:3 Summer: 9:-17: Monday to Friday (except statutory holidays) outlet name: Government Affairs Service Center outlet in Qikai District. No.7766, Dongfeng Street, Automobile Development Zone Management Committee Branch Tel: 431-8151237 Office hours: 8:3-16: in winter: 8:3-16:3 in summer (except legal holidays) Branch Name: Lvyuan District Government Affairs Service Center Branch Address: No.6665, Xi 'an Road, Changchun City, Jilin Province Tel: 431-. Office hours: 8:3-16: in winter; 8:3-16:3 in summer; Monday-Friday (except statutory holidays); outlet name: Administration Service Center of Economic Development Zone; outlet address: No.6188, Jilin Road, Changchun; Tel: 431-8996186 Office hours: 8:3-16: in winter.