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Home Service Guide Zhengzhou Municipal Food and Drug Administration Text
Category I Medical Device Production Fill in Record Service Guidelines
Date：04/04/2017  
Item Name Category I Medical Device Production Fill in Record Service Guidelines
Rights and Liablities Item No.
Issuing Authority Zhengzhou Area of China(Henan) Pilot Free Trade Zone
Service Subject Legal person
Implementing Basis
Application Condition Engaged in medical equipment production, should have the following conditions:
1. possess appropriate production sites, environmental conditions, production equipment and professional and technical personnel in line with the production of medical equipment;
2. equipped with the quality inspection of the production of medical equipment facility or full-time inspectors and testing equipment;
3. established a quality management system to ensure the quality of medical equipment;
4. possess ample after-sales service capacity in accordance with the production and sales of medical equipment;
5. other requirements stated in the product development, production process regulation.
Application Materials 1. The submission material shall have a clear directory;
2. the submission material should be arranged in order and bind accordingly, each part shall have a front cover, and each part shall have ablank sheet in between to distinguish different part;
3. one copy material should be submitted, using A4 size paper to print. The content should be complete, clear, with no alteration. The government departments and other agencies issued document shall be provided by its original size. Where bound into a book, not split is allowed;
4. where the photocopied document is used, the copy should be clear and consistent with the original;
5. the application contents should be consistent in all application material;
6. all document should be stamped with the official applicant seal;
7. The content of electronic data should be consistent with the paper document.
Change record material submission
Transaction Procdure Acceptance → technical review → on-site inspection → audit → check
Transaction Time Limit
Implementing Authority Zhengzhou Food and Drug Administration
Charge or not No
Fee Standard None
Fee Basis
Online Application or not No
Business Supervision Department
Office Hours Mon. - Fri. 9: 00-12: 00 13: 00-17: 00
Office Address The 1st and 2nd floor of Building 1, No. 85, Yabao Oriential International Plaza, Jinshui East Road, Zhengzhou. (Zip Code 450046)
Contact Phone 0371-67888393
Complaint Phone 0371-67880110
Relevant Forms
Flow Chart
Common Questions
Notes
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Integrated Service Center of China (Henan) Pilot Free Trade Zone Zhengzhou Area
Add.:1 Yabao·Dongfang International Plaza,No.85 Jinshui East Road,Zhengdong New District,Zhengzhou,Henan,China
Tel.:+86 0371-61170000    0371-67880002 E-mail:zzszzq@126.com
Integrated Service Center of China (Henan) Pilot Free Trade Zone Zhengzhou Area