Changchun City for the first class medical device production record what materials are needed?

I, in Changchun City for the "first class medical device production record" need to bring the following materials to apply:

1. General need to provide: the first class medical device production record form (electronic version: 1 original; copy 0; 1. The record form is filled out completely and in strict accordance with the "Instructions for filling out the form". And at the same time attached to the filing form electronic document. 2. 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. 3. The filing materials, 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.)

2. Generally required: the legal representative's identity, the identity of the person in charge of the enterprise, production, quality and technology responsible person's identity (paper: 0 originals; 1 copy; real and effective.)

3. Generally required: process flow diagram (paper and electronic: 0 original; 1 copy; real and effective.)

4. General conditions need to provide: proof of authorization of the operator (paper and electronic: 1 original; copy 0; real and effective.)

5. General conditions need to provide: filed product technical requirements/product standards (paper and electronic version: 0 copies of the original; copy 1; real and effective.)

6. General conditions need to provide: enterprise business license (paper: 0 original; copy 1; real and effective.)

7. General conditions need to provide: facilities, environmental documents (special production environment requirements, should also submit facilities, environmental documents) (Paper: 0 original; 1 copy; real and effective.)

8. Generally required: production, quality and technical personnel in charge of the academic title certificate (paper and electronic: 0 originals; 1 copy; real and effective.)

9. Generally required: documents proving the production site (paper: 0 originals; 1 copy; real and effective.)

10. General conditions need to provide: production management, quality inspection positions, employees, academic titles list (paper and electronic: 1 original; copy 0; real and effective.)

11. General need to provide: the production of medical devices for the record certificate (paper: 0 original; copy 1; true and valid.)

12. General need to provide: quality manual and program documents (paper and electronic version: 0 original; copy 1; real and effective.)

13. General need to provide: the main production equipment and inspection equipment catalog (paper and electronic: 0 copies of the original; copy 1; real and effective.)

Second, the matter of charges:

No charge

Third, time limit

1 working days

Fourth, 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 centers or public **** by 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 Branch Tel: 0431-84285756 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

Branch Name: Yushu Municipal Government Service Center Branch Address: Yushu Municipal Government Service Center (Southeast of Yushu Municipal Government) Branch Tel: 0431-83835541 Office Hours. Winter: 8:30-16:00 Summer: 8:30-16:30 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, 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: Dewei Municipal Government Service Center Office Address: 0431-83835541 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays)

On the other hand, the office hours are as follows 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: 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: Jingkai District Government Service Center Office Address: No. 6188, Jilin Road, Changchun City, Jilin Province, China Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays). Friday (except legal holidays)