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Home Service Guide Zhengzhou Municipal Food and Drug Administration Text
Category I Medical Equipment Products Fill in Record Service Guidelines
Date：04/04/2017  
Item Name Category I Medical Equipment Products 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
Application Materials 1. online print of the category I medical equipment fill in table, and stamp after print (automatically generated after online submission, can print afterward);
2. safety risk analysis report;
3. product technical requirements;
4. product inspection report;
5. clinical evaluation data;
6. product brochures and minimum sales unit label design sample;
7. manufacturing information;
8. certificate documents;
9. Declaration of Conformity;
10. the legal representative power of attorney.
Record material should be complete, clear, and print using A4 paper, and bonded with a catalog, and stamped with the official seal. The electronic version shall submit together.
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