Self Check for Medical Device Company

Friday, 24 June 2016 14:01

The state food and drug administration issued an announcement [2016 No. 112] that the class B and class C medical device company should have a self check on below issues.


  • The company which is engaged in medical device wholesale sold the medical device to whom with no qualification; OR purchases the medical device from the suppliers who have no proper qualification.
  • Operating conditions are changed and it is no more meet the requirement for the medical device quality management specification, but the company had not made the relevant rectification; OR changes the business premises or warehouse, expense its business scope or set up the storage house without permission.
  • To provide false information or by other fraudulent means for the purpose of obtaining the medical device operation license; OR forge, alter, buy, sell, lease, lend the medical device operation license or the medical device operation recording certificate.
  • To engage in the operation of class C medical devices without the valid permit, or do not make term extension after the expiration of the permit and still engage in the class C medical devices’ operation.
  • To engage in the operation of class B and C medical devices without the permit, especially for the imported medical device, its has no product’s license.
  • The medical device does not meet the mandatory standards or the technical requirements of registration or filing of product; OR without the qualification license, the license is expired, invalid and out-of-date.
  • The medical device manuals and labels do not meet the relevant requirement; OR the transportation and storage measure does not meet the requirement on the manuals or labels, especially for those products need the low temperature and cold chain management.
  • The company has not set up or implemented the check and recording policies for the purchasing the medical device; OR the company has not set up or implemented the sales recording policies for wholes and retail of the medical devices.


If the company finds itself engage in any illegal activities, it should positively report to the competent food and drug administrative bureau before 15TH July 2016.


Further, FDA will pay special attention to three kinds medical device companies: (1) the companies has the low management ability and find less problem by itself, (2) the company’s business needs to involve in the low temperature and cold chain; and (3) the companies engage in the imported medical devices.


Dongjin suggests the medical device company should take good care of this policy and make the self–check in due time.


If you have any questions, please send the email to me.

Ms. Jojo Hu

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