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What information is needed to apply for a Shenzhen medical device license??What's the process??

A medical device business license is a must-have document for medical device operating companies.,Establishing a second-category medical device operating enterprise,should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government;Establishing a third-category medical device operating enterprise,Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government,And issued a "Medical Device Business Enterprise License"。

Medical device business license is now post-approval,The industrial and commercial administration department shall apply for approval after issuing a business license.。The "Medical Device Business Enterprise License" is valid for 5 years。

What documents are needed to apply for a medical device license??what conditions?which processes?Method/steps:

  1. Company name approval notice)Or company business license with official seal;2 、legal representative(Business person in charge)Copy of ID card、Copy of college diploma or above;
  2. Copy of ID card of the quality manager、Copy of diploma from college or above related to medical device;4 、Copy of ID card of quality inspector、Copies of professional documents from technical secondary school or above related to medical devices;5 、Copy of warehouse keeper’s ID card、Copies of professional documents from technical secondary school or above related to medical devices;
  3. Copy of salesperson’s ID card、Copy of above-mentioned technical secondary school diploma;7 、Copy of ID card of after-sales maintenance personnel、Copy of above-mentioned technical secondary school diploma;8 、Copy of office title
  4. Copy of warehouse title
  5. Prepare product registration certificate、Copy of product technical quality specifications to apply for Shenzhen medical device business license,One-stop entrepreneurial platform Shenzhen Medical Device Business License Application Center,One to one service,Complete online processing,「」Shenzhen Medical Device Business License,Thousands of customer services,Apply first and pay later,Safe and guaranteed。

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