1. General need to provide: "Class II medical device business record change table" (electronic version: 1 original; copy 0; declare the record log on the State Food and Drug Administration - Medical Device Manufacturing License (filing information system) to fill in the requirements, while submitting paper materials; filing materials should be complete and clear, using A4, and submit paper materials. 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, printed and bound using A4 paper with a table of contents, copies stamped with an official seal.)
2. General need to provide: Class II medical device business filing voucher (paper: the original 0; 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; filing materials should be complete, clear, printed and bound using A4 paper and with a table of contents, a copy of the stamped seal. (And accompanied by a table of contents, copies stamped with an official seal.)
3. General need to provide: legal representative identification, identification of the person in charge of the enterprise, the quality of the person in charge of identification (paper: 1 original; 0 copies; 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; the filing materials (Should be complete, clear, printed and bound using A4 paper with a table of contents, copies stamped with an official seal.)
4. General need to provide: legal representative of the academic certificate or certificate of title (paper and electronic version: 1 original; 0 copies; 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 record materials should be complete, clear, use A4 paper printed and bound with a table of contents, copies stamped with the official seal. (Paper printed and bound with a table of contents, copies stamped with an official seal.)
5. General need to provide: proof of authorization of the operator and other supporting materials (electronic version: 0 originals; 0 copies; 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 the paper materials; filing materials should be complete, clear, print and bind with a table of contents, photocopies with A4 paper). (Bound and with a table of contents, copies stamped with the official seal.)
6. General need to provide: business premises, warehouse address of the geographic location, indoor floor plan (electronic version: the original 1; copy 0; 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, and (Use A4 paper printed and bound 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) (electronic version: 0 originals; 1 copy; 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 and clear, using A4 paper printing and binding with a directory, copies stamped with a seal. (The materials should be complete, clear, printed and bound using A4 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: 1 original; 0 copies; 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; filing materials should be complete, clear, print and bind with a table of contents, photocopies stamped with the official seal. (Bound and with a table of contents, copies stamped with an official seal.)
9. General need to provide: business facilities and equipment directory (electronic version: 0 copies of the original; 0 copies; declare the filing of 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 on A4 paper with a directory, copies stamped. (Catalog, copies stamped with the official seal.)
10. General need to provide: business quality management system, work procedures and other documents directory (electronic version: 0 original; 0 copies; declare for the record by logging 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; filing materials should be complete, clear, use the A4 paper printed and bound with a catalog, copies stamped with an official seal.)
11. General need to provide: warehouse land housing property rights documents or lease agreement (with housing property rights documents) (electronic version: 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; filing materials should be complete and clear, using A4 paper printing and binding with a directory, copies stamped with a seal. (The materials should be complete, clear, printed and bound using A4 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 or proof of academic title (paper and electronic version: 1 original; 0 copies; 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 paper materials; the record materials should be complete, clear, use of A4 paper printed and bound with a table of contents, copies stamped. A4 paper printed and bound with a catalog, copies stamped with an official seal.)
13. General need to provide: signed and stamped application form scanned upload (electronic version: 0 originals; 0 copies; 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 the paper materials; filing materials should be complete, clear, using A4 paper (Printed and bound with a table of contents, copies stamped with an official seal.)
14. General need to provide: business license or other subject qualification documents (paper: 0 originals; 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; the record materials should be complete, clear, using A4 paper) (Printed and bound with a table of contents, copies stamped with an official seal.)
15. General need to provide: proof of quality of the person in charge of education or title (paper and electronic version: 1 original; 0 copies; 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 A4 paper printed and bound with a table of contents, copies stamped with a seal. A4 paper printed and bound with a catalog, copies stamped with an official seal.)
16. General need to provide: organization and departmental setup description (paper and electronic version: 1 original; 0 copies; 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 and clear, using A4 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
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 consult the domicile of the government service centers or public **** phone first 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: 3rd Floor, Nong'an County Government Service Center Office Address: 1616 Debiao Street, East of Nong'an County Longfu Plaza, Changchun City, Jilin Province Office Phone: 0431-83279001 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday through Friday (except legal holidays)