1. General need to provide: "Class II medical device business filing form" (electronic version: the original 1; copy 0; declare the filing of the log on to the State Food and Drug Administration -Medical device production and operation license (filing) information system, fill in the requirements, while submitting paper materials; filing materials should be complete, clear, printed and bound using A4 paper with a table of contents, copies stamped with an official seal.)
2. Generally required: proof of the legal representative's academic qualifications or title (paper and electronic: 1 original; 1 copy; check the original.)
3. General conditions need to provide: proof of identity of the legal representative, the identity of the person in charge of the enterprise, the identity of the person in charge of quality (paper and electronic: 1 original; 1 photocopy; declared for the record log on to the State Food and Drug Administration - Medical Device Manufacturing License (for the record) Information System, fill in the requirements, while submitting paper materials; (The filing materials should be complete, clear, printed and bound using A7 paper with a table of contents, copies stamped with an official seal.)
4. In general, you need to provide: business license (paper and electronic version: 0 original; 1 copy; check the original, uniformly photocopied on A4 paper.)
5. General need to provide: proof of authorization of the operator and other supporting materials (electronic: 1 original; copy 0; declare the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting the paper materials; the record materials should be complete, clear, use A22 paper (Printed and bound with a table of contents, copies stamped with an official seal.)
6. General need to provide: business premises, warehouse address of the geographic location, indoor floor plan (paper and electronic version: 0 original; 1 copy; declare the record log on to the State Food and Drug Administration - Medical Device Manufacturing License (for the record) Information System, fill in the requirements, while submitting the paper material; the record material should be complete, Clear, using A17 paper printing and binding with a catalog, copies stamped with an official seal.)
7. General need to provide: documents proving ownership of the premises or lease agreement (with documents proving ownership of the premises) (paper and electronic: 0 originals; 1 copy; declaration of the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting paper materials; (The filing materials should be complete, clear, printed and bound using A16 paper with a table of contents, copies stamped with an official seal.)
8. General need to provide: scope of business, business mode description (paper and electronic version: 0 original; copy 1; declare the filing of logging on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting paper materials; filing materials should be complete, clear, using A13 paper (Printed and bound with a table of contents, copies stamped with an official seal.)
9. General need to provide: business facilities and equipment directory (paper and electronic version: 0 original; 1 copy; declare the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting the paper material; the record material should be complete, clear, print and bind with directory, copy of the use of A20 paper (Bound and with a table of contents, copies stamped with the official seal.)
10. General need to provide: business quality management system, work procedures and other documents directory (paper and electronic version: 0 original; 1 copy; declare the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting the paper material; the record material should be complete, clear (The documents should be complete, clear, printed and bound on A21 paper with a table of contents, and the copies should be stamped with an official seal.)
11. General need to provide: warehouse land house ownership documents or lease agreement (with documents proving house ownership) (paper and electronic version: 0 original; copy 1; declare the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting paper materials; (The filing materials should be complete, clear, printed and bound using A19 paper with a table of contents, copies stamped with an official seal.)
12. General need to provide: proof of the person in charge of the enterprise's academic qualifications or title (paper and electronic version: the original 1; copy 1; declaration of the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting paper materials; filing materials should be complete, clear, use the A10 paper printing and binding with a catalog, copies stamped with an official seal.)
13. General need to provide: proof of quality of the person in charge of education or title (paper and electronic version: the original 1; copy 1; declaration of the record log on to the State Food and Drug Administration - Medical Device Manufacturing License (for the record) Information System, fill in the requirements, while submitting paper materials; filing materials should be complete, clear, using the A11 paper printing and binding with a catalog, copies stamped with an official seal.)
14. General need to provide: organizational structure and departmental setup description (paper and electronic version: 0 original; copy 1; declare the record log on to the State Food and Drug Administration - Medical Device Manufacturing Licensing (for the record) Information System, fill in the requirements, while submitting the paper material; the record material should be complete, clear, using A12 paper (Printed and bound with a table of contents, copies stamped with an official seal.)
Second, the matter of fees:
No fee
Third, the time limit for handling
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 Center or Public **** 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)