In Changchun how to handle "Class II medical device business record (change)?

A, in Changchun for the "second class of medical devices for the record (change)" need to bring the following materials to apply: 1. General need to provide: "second class of medical devices for the record to change the table" (electronic version: the original 1; copy 0; declaration of the record log on 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. General need to provide: Class II medical device business filing voucher (paper: the original 0; copy 1; 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; filing materials should be complete, clear, using A4 paper printed and bound with a table of contents, a copy of the seal. (Copies stamped with the 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 filing of logging 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 materials; filing materials should be complete, clear, and (Use A4 paper printed and bound with a directory, photocopies stamped with an official seal.) 4. General need to provide: legal representative of the academic certificate or certificate of title (paper and 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, printed and bound on A4 paper with a directory, a copy stamped with the official seal. (With a catalog, a copy of the official seal.) 5. General need to provide: proof of authorization of the operator and other supporting materials (electronic version: 0 originals; 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, printed and bound on A4 paper with a table of contents, copies stamped. , copies stamped with the official seal.) 6. General need to provide: business premises, warehouse address of the geographic location, indoor floor plan (electronic version: 1 original; 0 copies; declare for the record by logging 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 materials; the record materials should be complete, clear, print and bind with a table of contents, copy of the use of A4 paper (Bound with a directory, a copy of the 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 copies of the original; 1 copy; 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 paper materials; filing materials should be complete and clear) (The use of A4 paper printing and binding with a directory, copies stamped with the official seal.) 8. General need to provide: scope of business, business mode description (paper and electronic version: 1 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 material; the record material should be complete, clear, printed and bound on A4 paper with a directory, copies stamped with the seal. (The copy should be stamped with the official seal.) 9. General need to provide: business facilities and equipment directory (electronic version: 0 copies of the 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 paper materials; the record materials should be complete, clear, printed and bound using A4 paper with a table of contents, a copy of the (Add 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 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, printed and bound using A4 paper and with a directory, copies with official seal. (And with a directory, a copy of the official seal.) 11. General need to provide: warehouse land building ownership documents or lease agreement (with documents proving ownership of the house) (electronic version: 0 copies of the original; 1 copy; 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 paper materials; filing material should be complete, clear (The use of A4 paper printing and binding with a directory, copies stamped with an official seal.) 12. General need to provide: proof of academic qualifications of the person in charge of the enterprise or proof of title (paper and electronic version: 1 original; 0 copies; 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 the paper materials; the record materials should be complete, clear, printed and bound using A4 paper with a directory, a copy stamped with the official seal. (With a directory, a copy of the official seal.) 13. General need to provide: signed and stamped application form scanned upload (electronic version: 0 originals; 0 copies; declare 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 the paper materials; filing materials should be complete, clear, printed and bound using A4 paper with a directory, photocopies stamped. (Catalog, a copy of the official seal.) 14. General need to provide: business license or other documents to prove the qualifications of the main body (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, printed and bound using A4 paper with a directory, photocopies stamped. (Catalog, a copy of the official seal.) 15. General need to provide: proof of quality of the person in charge of academic qualifications 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 License (for the record) Information System, fill in the requirements, while submitting the paper materials; the record materials should be complete, clear, printed and bound using A4 paper with a directory, a copy stamped with the official seal. (With a catalog, a copy of the official seal.) 16. General need to provide: organizational structure and departmental setup instructions (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, printed and bound on A4 paper and with a (Catalog, copies stamped with the official seal.) Second, the matter of charges: no charge Third, for a time limit of 1 working day 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 first phone call to the government service center or public **** service centers. Outlet Name: Nong'an County Government Service Center, third floor Outlet Address: 1616 Debiao Street, East of Longfu Square, Nong'an County, Changchun City, Jilin Province Outlet Phone: 0431-83279001 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Outlet Name: Jingyue Development Zone, the Center for Government Services Outlet Address. No. 6666, Eco Street, Jingyue District, Changchun City, China Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Office Name: Shuangyang District Government Service Center Office Address: South of Dinglu Square, Shuangyang District, Changchun City, China Office Phone: 0431-84285756 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Name of the outlet: Yushu Municipal Government Service Center Address of the outlet: Yushu Municipal Government Service Center (southeast of the Yushu Municipal Government) Telephone: 0431-83835541 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) 30 Monday to Friday (except legal holidays) Name of the outlet: Dewei Municipal Government Service Center Address of the outlet: 100 meters west of the intersection of Dexing Road and Huixin Road in Dewei City Tel: 0431-87000815 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Name of the outlet: Jutai District Government Service Center Service Center Branch Address: Jiu Tai District, Changchun City, Jilin Province, Changtong Road and Fulin Street Interchange Minsheng Building Branch Tel: 0431-81367322 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch Name: High-tech District Government Service Center Branch Address: Changchun High-tech District Shuangchuang Center Branch Tel. 0431-82532700 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch Name: Chaoyang District Government Service Center Branch Address: No. 1149, Yan'an Avenue, 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) Name of the outlet: Erdao District Government Service Center Address of the outlet: No. 799 Huigong Road, the intersection of Huigong Road and Guangde Street, Erdao District, Changchun City, Changchun City, China Tel: 0431-89177966 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch Name: Changchun Municipal Government Service Center Branch Address: No. 3177, Puyang Street, Changchun Branch Tel: 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: Changchun City, Nanguan District, Jiayuan Road, No. 399, the Nanguan Traffic Police Force East Branch Tel: 0431-89682700 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Branch Name: Kuancheng District Government Service Center Branch Address: 228 Fucheng Road, Kuancheng District, Changchun City Branch Tel: 0431-89991639 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) :00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Outlet Name: Lianhua Mountain Government Service Center Outlet Address: Lianhua Mountain Resort District, Quanye Town, fog nine Road No. 1 Outlet Phone: 0431-81336520 Office Hours: Winter: 9:00-16:30 Summer: 9:00-17:00 Monday to Friday (except legal holidays) outlets Name: Vehicle Opening District Government Service Center Branch Address: Vehicle Opening District, Changchun City, Vehicle Opening District, Dongfeng Street, No. 7766, Vehicle Opening District Management 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: No. 6665 Xi'an Road, Changchun City, Jilin Province 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: No. 6665 Xi'an Road, Changchun City, Jilin Province Branch Tel: 0431-81501237 No. 6665, Xi'an Road, Changchun City, Jilin Province Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday to Friday (except legal holidays) Office Name: Nong'an County Government Service Center, 3rd Floor Office Address: No. 1616, De Biao Street, East of Longfu Square, Nong'an County, Changchun City, Jilin Province Office Hours: Winter: 8:30-16:00 Monday to Friday (except legal holidays) Office Address: No. 1616, Debiao Street, East of Longfu Plaza, Nong'an County, Changchun City, Jilin Province Office Hours: No. 431-83279001 Office Hours: Winter: 8:30-16:00 Summer: 8:30-16:30 Monday through Friday (except legal holidays)