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Requirement for Different Kinds of Medical Device Business Operation Certificate

Wednesday, 13 May 2015 18:14

Due to the advance of the overseas medical device and great needs in the Chinese market, more and more investors want to set up medical device operation WOFE in China. At the same time, with the opening of the Chinese market, the Chinese government further adjusted the application procedures for different kinds of medical device’s application. Please refer to the below details.

Medical Device Business Operation Certificate

Grade I

Grade II

Grade III

Website to check the kinds

http://app1.sfda.gov.cn/

Policy

N/A

Recording

Registration: the legal operation is subject to the medical device business certificate

Business scope on the business license

The wholesale, import and export, commission service (OR the retail) of the Grade I/II/III medical device; to provide the technical consulting in respect of the medical device;

Business scope on the medical device business operation certificate

N/A
  • Grade II medical device (including in vitro diagnostic reagent)
  • Grade II medical device (exclusive of in vitro diagnostic reagent)
  • The retailing of Grade II medical device
    		•
  • Grade III medical device: the detailed product name
    		•

    Other requirement

    N/A
  • Such medical device should be registered in China.
  • The person-in-charge for quality control should be a full-time staff with at least the bachelor degree on the academy of “medical device/mechanical/digital/biology/chemical/medical/druging/chemical industry/computer” and with over three years working experiences involving in the quality control for the medical device.
  • The using area for the office should be no less than 30 square meters.
  • The using area for the warehouse should be no less than 15 square meters.
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