Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Card News

Business Report Episode 2_Drugs & Medical Devices Focused on the Patient
  • Registration Date 2020-06-23
  • Hit 832
Patient-centered management of drugs & medical devices

No worries about side effects!
We're conducting long-term follow-up studies to expand patient safeguards
Conducting long-term follow-up studies so we can register patients who have received high-tech biopharmaceuticals, such as genetic medicines, and track/observe the status of their health
Register patients who have received biopharmaceuticals at the Regulatory Science Center
Track/Observe health condition via regular checkups, etc. centered around base hospital

So we can take swift action!
We're making medical device use reports mandatory
For medical implants, ensure patient status can be quickly identified when safety issues arise by performing whole-life-cycle tracking management from the moment of release to device use
(Current) Management of supply history from the release of medical device for distribution to medical institution
(Improved) Addition of device use history at medical institution

Rest easy even when problems arise!
We're operating an organization for investigations into causes to be prepared for the occurrence of health damage
Operate an exclusive organization to investigate causes when a patient's health has been undermined due to the use of a medical device and provide support for patient damage compensation litigation
Working to mandate subscription to liability insurance to facilitate compensation when negligence of manufacturer is recognized

Please refer to the Press Release on May 11, 2020 uploaded at our website under MFDS News > News & Notice for more information concerning this card news.
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Division 국제협력담당관

Written by 배성명

Telephone 043-719-1559