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Korea to allow fast-track review for innovative medical technologies
  • By Kwak Sung-sun
  • Published 2018.12.13 15:44
  • Updated 2018.12.13 15:44
  • comments 0

The government said it would introduce a fast-track evaluation procedure for advanced medical technologies that use robots, 3D printing, and nanotechnology.

The Ministry of Health and Welfare said it would prepare a revision of the rules on “Separate Evaluation Track for Innovative Medical Technology” by Jan. 23 next year.

If the rules are revised, advanced medical technologies with high potentials will be able to enter the market ahead of competitors from late January next year.

According to the ministry, the government will set up a separate review track for innovative medical technologies.

Technologies under a separate review should be a medical technology that used state-of-the-art technology, a medical technology with high social value, and medical technology expected to improve patient satisfaction.

The medical technology that uses an advanced technology includes robots, 3D printing, artificial intelligence, nanotechnology, and implantable medical technology, the ministry said. Those with high social value include medical technologies to treat cancer, heart diseases, cerebrovascular diseases, rare diseases, dementia and rehabilitating the disabled.

The separate review track will additionally check innovative medical technology’s potential value.

In potential value, the government will review the innovation of medical technology, influence on patient's life, the existence of alternative technology, and the possibility of misuse of the medical technology.

However, those that passed the separate track will be under evaluation three to five years after the market launch, based on the medical service results.

Medical device makers and physicians who apply for the separate review track should report the names of the medical institutions that collect research data for reevaluation to the New Medical Technology Assessment Committee.


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