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Home Service Guide Zhengzhou Municipal Food and Drug Administration Text
Category III "Medical Device Business license" Approve , Change Service Guidelines
Date：04/04/2017  
Item Name Category III "Medical Device Business license" Approve , Change Service Guidelines
Rights and Liablities Item No.
Issuing Authority Zhengzhou Area of China(Henan) Pilot Free Trade Zone
Service Subject Legal person
Implementing Basis (1)Regulations of the People's Republic of China on the Supervision and Administration of Medical Devices (Promulgated by the State Council's 39th Executive Session on February 12, 2014) Article 29: Engaged in medical equipment business activities, there shall be a place of operation and storage conditions suitable for the scale and scope of operation and the quality management system and quality management organization or personnel appropriate to the medical equipment to be operated. Article 31: Where a business enterprise engaged in the operation of the category III medical device shall apply to the food and drug administration department of the municipal people's government at the district where the applicant is located and submit its certificate of conformity to the conditions prescribed in Article 29 of these Regulations. The food and drug administration department that accepts the application for abusiness license shall, within 30 working days from the date of acceptance, conduct the examination and organize the verification if necessary. Where the conditions are met, the license shall be granted and issued. If the conditions are not met, the reasons to deny theapplicationshall be stated in writing. The medical equipment business license is valid for 5 years. If the renewal service is required upon the expiration of theold license, the continuation procedure shall be followed in accordance with the relevant laws and regulations of the administrative license. (2). "Decision of the State Council on the Cancellation and Adjustment of Administrative Examination and Approval Items in the Sixth Batch" (Guo Fa [2012] No. 52) Annex 2 Article 111 Name: "The category II and III medical device business license" administration is implemented by City Level People’s government food and drug administration.
Application Condition (1) 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;
(2) equipped with appropriate business premises in accordance with the scale of operation and business scope. The storageand management of medical equipment, shall not be set in residential and other places not suitable for business;
(3) 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;
(4) have appropriate quality management system in accordance with the operation of medical equipment;
(5) 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; Engaged in category III medical equipment business enterprises should also meet the medical equipment management quality management requirements of the computer information management system to ensure that the business can be traced back.
Application Materials "Medical equipment business license application form", the enterprise login http://www.hda.gov.cn/CL0145/ fill in the application and report, print "business license" and "organization code certificate" copy; (original will be returned after the verification check), with copy of the company's articles of association, organization structure and functions (framework) map, quality management system, work procedures and other documents directory, computer information management system basic information and functional description, with a copy of the software invoice; (original software invoice will be returned after verification), domicile and warehouse proof of use document (includes the lease agreement, the original lease certificate or free use of self-owned homes, provide the original proof of the property certificate, the originals will be returned after the verification check)
Transaction Procdure Acceptance → technical review → on-site inspection → audit → check.
Transaction Time Limit 7 working days (excluding expert review, on-site inspection, publicity time).
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
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Integrated Service Center of China (Henan) Pilot Free Trade Zone Zhengzhou Area