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Home Service Guide Zhengzhou Municipal Food and Drug Administration Text
Category II Medical Device Operation Fill in Record Service Guidelines
Date：04/04/2017  
Item Name Category II Medical Device Operation 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 business enterprises, should have the following conditions:
1. enterprises, enterprises legal representative or business person in charge, the quality management person in charge don't have the situation stipulated in "medical device supervision and management regulations," Article 63, Article 64, Article 65;
2. equipped with appropriate quality management agencies or quality management personnel suitable to its current the scale and scope of business. Quality management personnel should have a national recognition of the relevant professional qualifications/education or titles;
3. equipped with appropriate business premises in accordance with the scale of operation and business scope. The storage and management of medical equipment, shall not be set in residential and other places not suitable for business;
4. equipped with appropriate storage condition in accordance with the scale of operation and business scope. Enterprise operating on all commissioned by the third-party logistics, may not need to set up the warehouse;
5. have appropriate quality management system in accordance with the operation of medical equipment;
6. have appropriate professional guidance, technical training, and after-sales service capabilities in accordance with its business medical equipment products, or agreed by a third party to provide technical support;
7. the specific implementation of the standard in accordance with the "Forward State Food and Drug Administration on the issuance of medical equipment management quality management standards on-site inspection guidelines" (Henan Food and Drug Administration [2015] No. 163)
Application Materials 1. fill in the category II medical equipment operating record on Provincial Bureau website, and print (http://www.hda.gov.cn/CL0124/);
2. copy of the Business license and medical equipment business license (if any);
3. copy of the identity, education record, proof of title document of the legal representative of the enterprise or the person in charge, the quality control person in charge;
4. instruction about the Organization structure and departments set up of enterprise;
5. Business scope and mode of operation (using tabulated form, specify the product code, product name, registration number, sales channels);
6. Copy of the location of the business premises, the location of the warehouse address, the floor plan of the office space, the internal plan of the warehouse (indicating the length, width, and height), copy of the housing property certificate and the lease agreement (with the property certificate);
7. Business facilities and equipment catalog;
8. Enterprise management quality management system, work procedures, and the other documents directory;
9. Authorization letter of the sponsor;
10. The authenticity affidavit of the material submitted by the enterprise;
11. Other proof materials (enterprise with business scope including in vitro diagnostic reagents need to provide the following materials: in vitro diagnostic reagents inspection personnel ID card, laboratory related professional college or above education background or competent chief examiner title certificate; refrigerated car purchase invoice and registration paper; Automatic temperature record equipment invoice; spare generator invoice; quality management software invoice).
Record material should be complete, clear, use A4 paper to print and bind appropriately, with the directory, the division page between different parts. A stamped copy of the submission material document should be submitted at the same time.
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