1. In Changchun, the following materials are required to apply for "record change of medical device products of Class I": 1. Generally, it is required to provide a description of the change and relevant supporting documents (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 change description shall be accompanied by the change comparison table in the filing information table. . ) 2. Generally, it is required to provide: the filing information form of Class I medical devices (electronic version: 1 original; 0 copies; A4 paper printing, complete information. 3. General requirements: declaration of conformity (paper and electronic version: original 1 copy; 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 and 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. 4. General requirements: a copy of the business license of the enterprise (paper: 0 originals; 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. . 5. General requirements include: Catalogue 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. 6. Generally, it is required to provide: power of attorney (paper and electronic version: original 1 copy; 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. . ) 2. charge for this matter: no charge 3. Processing time 1 working day 4. Address Note: If the government service center or public service center in the administrative area where you live is not in the listed outlets, please call the government service center or public service center in your residence first. Network Name: Government Affairs Service Center of Economic Development Zone Network Address: No.6188, Jilin Road, Changchun City Internet Phone: 043 1-89960 186 Office hours: 8: 30 in winter-0/6: 00 in summer-8: 30-/KLOC. Central outlet address: Minsheng Building outlet at the intersection of Jiutai Mayor's Access Road and Fulin Street, Changchun City, Jilin Province Tel: 043 1-8 1367322 Office hours: 8: 30 in winter-0/6: 00: 8: 30-0/6: 30 in summer (. Address: No.6666, Ecological Street, Jingyue District, Changchun Tel: 043666 South Branch of Dinglu Square, Shuangyang District Tel: 043 1-84285756 Office hours: 8:30- 16:00 in winter and 8:30- 16:30 in summer. Telephone number of outlets: 043 1-870008 15 Office hours: 8: 30 in winter-16: 00: 8: 30-16: 30 in summer: Monday to Friday (excluding legal holidays) Name of outlets: Yushu Municipal Administration. 438+0-8383554 1 Office hours: 8: 30 in winter-16: 00 in summer: 8:30- 16:30 Monday to Friday (except statutory holidays) Network name: Chaoyang District Government Affairs Service Center Network address: Yan 'an, Changchun City, Jilin Province. +0-850907 18 Office hours: 8: 30 in winter-16: 00 in summer: 8:30- 16:30 Monday to Friday (excluding legal holidays) Network name: Government Affairs Service Center of High-tech Zone Network address: Shuangchuang Center of Changchun High-tech Zone Network Phone: Winter: 8:30- 16:00 summer: 8:30- 16:30 Monday to Friday (except statutory holidays) 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 Tel: 0431-80. 6:30 Monday to Friday (except statutory holidays) Network Name: Changchun Municipal Affairs Service Center Network Address: No.3177, Puyang Street, Changchun City Network Phone: 043 1-887790 17. Summer: 8:30- 16:30 Monday to Friday (except statutory holidays) 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-/kloc-0 in winter. 6:30 Monday to Friday (except statutory holidays) outlet name: Kuancheng District Government Affairs Service Center outlet address: No.228 Fucheng Road, Kuancheng District, Changchun Tel: 043 1-8999 1639 Office hours: 8:30 in winter:16: 00 in summer: 8: 00. 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. Address: No.7766 Dongfeng Street, Changchun Automobile Development Zone. Telephone number of outlets: 0431-81501237 Office hours: 8: 30 in winter-/0/6: 00 in summer-16: 30. Address of outlet: No.6665, Xi 'an Road, Changchun City, Jilin Province Tel: 043 1-89625000 Office hours: 8: 30 in winter-16: 00 in summer-8:30- 16:30: Name of outlet from Monday to Friday (except legal holidays). No.88 branch tel: 043 1-89960 186 Office hours: 8: 30 in winter-16: 00 in summer: 8:30- 16:30 Monday to Friday (except legal holidays).