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Blue-ribbon panel discusses medical device regulations
  • By Lee Han-soo
  • Published 2017.12.27 12:55
  • Updated 2017.12.27 12:55
  • comments 0

The Presidential Committee on the Fourth Industrial Revolution (PCFIR) said Wednesday that it held a hackathon to discuss methods on loosening the advanced medical device regulations and promoting its market.

The committee, formed on Aug. 16, works directly under the presidential office and plans to establish a foundation of science, technology, artificial intelligence, and data technology to cope with the advent of the fourth industrial revolution based on super intelligence and connection.

It also deliberates and coordinates issues related to forming the new industry and service, as well as significant policies needed to cope with social changes that may occur.

During the meeting, related organizations and government departments came to a consensus that advanced medical devices should be regulated appropriately for an expedited entry into the market, where speed is essential.

As a result, the committee agreed to introduce a “fast track system” at the approval stage of advanced medical devices and promote a global mutual recognition system.

Regarding the new medical technology evaluation system, the committee acknowledged that the safety of the people was most important. The participants also agreed to set up a value-based evaluation track reflecting the social and clinical values along with the documentary procedures to ensure the continuous development of advanced medical technology.

There was an additional consensus among the committee members concerning the need for government support and recognition of health insurance to ensure the expansion of high-tech medical devices in both domestic and overseas markets.

Upon the committee’s request, the government promised to make efforts to vitalize the domestic and overseas markets of high-tech medical devices, such as the enactment an amendment promoting medical devices.

The participants also discussed other essential agendas such as the cooperation between the financial and Fintech industries, and the law on protecting and using the location of information.


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