How to handle "Class I medical device product registration change" in Changchun?

1. To apply for "change of registration of Class I medical device products" in Changchun City, you need to bring the following materials to apply: 1. In general, you need to provide: a description of the change and relevant supporting documents (paper and electronic versions) : 1 original; 0 copies; 1. The registration materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. If there are no special instructions, the product registration materials should be submitted. Signed and sealed by the filing person. “Signature” means: the filing person’s seal, or the signature of the filing person and the company’s seal. The seal must be the filing person’s official seal. 3. Changes. The description of the situation should be accompanied by a comparison list of changes in the filing information form.) 2. In general, it is necessary to provide: Class 1 medical device filing information form (electronic version: 1 original; 0 copies; printed on A4 paper, with complete information. .) 3. In general, you need to provide: Declaration of compliance (paper and electronic version: 1 original; 0 copies; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted with the company. The electronic version shall be submitted together. 2. If there are no special instructions, the product registration information shall be signed and sealed by the filing party, or the signature of the filing party and the seal of the company. The seal must be the official seal of the filing person, and the special seal for registration shall not be used. 3.1 Declaration that it meets the relevant requirements for medical device registration; 3.2. Declaration that this product complies with the relevant contents of the Class I medical device product catalog and the corresponding in vitro diagnostic reagent classification sub-catalog; 3.3 Declare that this product complies with current national standards and industry standards and provide a list of compliance standards; 3.4 Declare the authenticity of the submitted filing materials) 4. In general, you need to provide: a copy of the business license (paper: 0 original; 1 copy. 1. The registration materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. If there are no special instructions, the product registration materials should be signed by the filing person. "Seal" refers to: the seal of the filing person, or the signature of the legal representative or person in charge plus the seal of the company. The seal must be the official seal of the filing person, and the special seal for registration is not allowed.) 5. In general, you need to provide: application materials Catalog (paper and electronic version: 1 original; 0 copy; 1. The filing materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. Product filing materials If there is no special explanation, the "signature and seal" shall be the seal of the filing party, or the signature of the legal representative or person in charge plus the seal of the company, which must be the official seal of the filing party. Special seal for registration. 3. The information catalog includes the first-level and second-level titles of the entire application materials, and the volume and page number of each item are stated in a table.) 6. In general, a power of attorney is required (paper and electronic versions: 1 original; 0 copies; 1. The registration materials should be complete and clear, printed and bound on A4 paper, and the copies should be stamped with the official seal and submitted together with the electronic version. 2. If there are no special instructions, the product registration materials should be submitted by. Signature and seal of the filing party. "Signature and seal" refers to: the seal of the filing party, or the signature of its legal representative or person in charge plus the seal of the enterprise. The seal must be the official seal of the filing person, and the special seal for registration is not allowed. . ) 2. Charges for this matter: No charge 3. Processing time limit is 1 working day 4. Processing address Note: If the government service center or public service center in the administrative area where your residence is located is not among the outlets listed, please first Telephone consultation with the government service center or public service center in the place of residence.

Branch name: Economic Development Zone Government Service Center Branch address: No. 6188 Jilin Road, Changchun City Branch phone: 0431-89960186 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday ( Excluding statutory holidays) Branch name: Jiutai District Government Service Center Branch address: Minsheng Building, the intersection of Changtong Road and Fulin Street, Jiutai District, Changchun City, Jilin Province Branch phone number: 0431-81367322 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch name: Jingyue Development Zone Government Service Center Branch address: No. 6666 Ecological Street, Jingyue District, Changchun City Branch phone: 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: Branch on the south side of Dinglu Square, Shuangyang District, Changchun City Telephone: 0431 -84285756 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch name: Dehui City Administration Service Center Branch address: Dexing Road, Dehui City Branch phone number 100 meters westbound from the intersection with Huixin Road: 0431-87000815 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch name: Yushu City Government Service Center branch address: Yushu Municipal Service Center (southeast of Yushu Municipal Government) Branch phone number: 0431-83835541 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (statutory Except for holidays) Branch name: Chaoyang District Government Service Center Branch address: No. 1149 Yan'an Street, Changchun City, Jilin Province Branch phone: 0431-85090718 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch name: High-tech Zone Government Service Center Branch address: Changchun High-tech Zone Mass Entrepreneurship Center Branch phone: 0431-82532700 Office hours: Winter: 8:30-16:00 Summer: 8:30- 16:30 Monday to Friday (except legal holidays) Branch name: Erdao District Government Service Center Branch address: No. 799 Huigong Road, the intersection of Huigong Road and Guangde Street, Erdao District, Changchun City Branch phone: 0431-89177966 Office Time: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch name: Changchun Municipal Affairs Service Center Branch address: No. 3177 Puyang Street, Changchun City Branch phone number: 0431-88779017 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch name: Nanguan District Government Service Center Branch address: Nanguan District, Changchun City Telephone number of the east branch of Nanguan Traffic Police Team, No. 399 Jiayuan Road: 0431-89682700 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (excluding statutory holidays) Branch name: Kuancheng District Government Service Center branch address: No. 228 Fucheng Road, Kuancheng District, Changchun City Branch phone number: 0431-89991639 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (statutory Except for holidays) Branch name: Lianhuashan District Government Service Center Branch address: No. 1, Wujiu Road, Quanyan Town, Lianhuashan Resort

Hotline: 0431-81336520 Office hours: Winter: 9:00-16:30 Summer: 9:00-17:00 Monday to Friday (except legal holidays) Branch name: Qikai District Government Service Center Branch address: Changchun City Qikai District Management Committee outlet phone number: 7766 Dongfeng Street, Qikai District: 0431-81501237 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (excluding statutory holidays) outlets Name: Green Park Government Service Center Branch Address: No. 6665 Xi'an Road, Changchun City, Jilin Province Branch Phone: 0431-89625000 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday ( (Except statutory holidays) Branch name: Economic Development Zone Government Service Center Branch address: No. 6188 Jilin Road, Changchun City Branch phone: 0431-89960186 Office hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except statutory holidays)