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Moon vows to ease excessive regulations on medical devices
  • By Kwak Sung-sun
  • Published 2018.07.20 16:34
  • Updated 2018.07.20 16:34
  • comments 0

President Moon Jae-in pledged to get rid of excessive regulations on medical devices, such as allowing safe devices to enter the market first and review them later. Such lowered barriers will significantly reduce the time of in-vitro medical devices arriving in the market to 80 days from over a year.

The Moon administration also plans to review giving cash to hospitals to purchase advanced medical equipment such as continuous glucose monitor by March 2019.
To spur the growth of the medical device industry, research-centered hospitals will be able to establish an “industry-hospital cooperation body.” Also, research-centered hospitals will be certified, not designated, by the government.

President Moon Jae-in gives direct briefings to physicians, explaining how the government will seek deregulation for medical devices and nurture related industries, at Bundang Seoul National University Hospital’s Healthcare Innovation Park in Seongnam, south of Seoul, Thursday.

Moon visited Seoul National University Bundang Hospital’s Healthcare Innovation Park on Thursday and gave direct briefings to physicians on how the government will seek deregulation for medical devices and nurture related industries.

“I will support a new challenge to save people’s lives. Revamping the old practices, institutions, and removing unnecessary regulations will be beginning of the work,” Moon said.

Moon said he heard that it was more difficult for medical device makers to get approval and technological assessment than to develop the device.

“They had to visit multiple government agencies to get approval, but they did not even have a chance to explain about their product when receiving the regulatory assessment. I will radically improve this inefficient structure,” he added.

Moon explained about detailed plans for improvement.

“We will make a separate evaluation procedure for advanced medical devices so that if they prove their innovative merit, we will allow them to be put on the market immediately,” he said. “A company developed a diagnostic kit for patients to check themselves after breast cancer surgery but failed to win the nod just because it did not have a local clinical backup. This won’t happen from now on.”

For in-vitro diagnostic devices that secured safety, the government would reduce the licensing processes and evaluate them after the market release, Moon said. Such regulation easing is called a “negative list” system in Korea. “We will start the system for in-vitro testers that use blood or urine to diagnose a disease and an infection,” he said.

Moon also vowed to minimize the approval process, which used to be long and difficult.
To obtain approval for a medical device, get the technical evaluation, and to receive insurance benefits, companies had to receive separate nods from the Ministry of Food and Drug Safety, the National Evidence-based Healthcare Collaborating Agency, and the Health Insurance Review and Assessment Service.

From now on, the government would provide an integrated service to make the three procedures progress simultaneously, Moon said.

The president also expressed his strong will to nurture the medical device industry as the new business for the future.

“Physicians’ experience in patient care and hospitals’ research achievements are valuable assets. I will make sure these assets will be used to develop medical devices that are essential in the medical field,” Moon said. “To do this, the government will increase the number of research-centered hospitals across the nation and establish an industry-hospital cooperation body to give it the same benefits that go to industry-academy cooperation bodies.”

Moon went on to say that the government will also expand support for hospital test beds which can improve the performance of local medical devices and compare them with foreign products.

“We will establish the Medical Device Industry Promotion Act and the In-vitro Diagnostic Medical Device Act to accelerate the development of innovative medical technologies. We will also build a tech/venture fund with a size of over 30 billion won ($26.4 million) to commercialize innovative technologies and ideas,” he added.


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