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Shortened 100-day entry into newly developed medical device market..
Concurrent review of new medical technology evaluation and insurance
- Ministry of Health and Welfare promulgated 'Regulations on Evaluation of New Medical Technology’
The entry into the newly developed medical device market is shortened by about 100 days.
The Ministry of Health and Welfare (Minister Neunghoo Park) revised
the "New Health Technology Evaluation Regulations" and
the "Regulations on Standards for National Health Insurance Medical Care Benefits"
revised on July 4 (Thursday).
The review of 'new medical technology evaluation - review of insurance etc.'
will be a follow-up to the "Medical Device Regulation Innovation and Industry Development Plan"
announced in July 2018
The complicated regulatory process was promoted to improve the part of the market
that took a while to enter the market.(Up to 490 days)
The Korea Health & Medical Research Institute (President Lee Young-sung)
and the Health Insurance Review and Assessment Agency (President Kim Seung-Taek)
have formed a consultative body for institutional improvement and have sought concrete measures.
The amendment of the "New Medical Technology Evaluation Rules"
(Ministry of Health and Welfare Ordinance) revises the new medical technology evaluation
and insurance reexamination concurrently to shorten the market entry time of newly
developed medical devices.
When evaluating new medical technology, if you submit data
(including data on the cost effectiveness of medical activities,
medical equipment, treatment materials, etc.)
to the Korea Health and Medical Research Institute for reimbursement
is also performed automatically.
As a result, when the 'new medical technology evaluation' is completed,
it will be possible to terminate the insured entry examination,
thereby shortening the medical device market entry time by
about 100 days (up to 390 days).
Ministry of Health and Welfare Ministry of Health Resources Policy Director Son Jun-ho said,
"As the market for newly developed medical devices is shortened by about 100 days,
the difficulty of the industry that has occurred due to the prolonged period of entering
the market will be largely eliminated.“
Details of the amendment can be found at Nurizip of the Ministry of Health and Welfare
→ Information → Law → Legislative and Administrative Notice.
SENDEX 2019 Secretariat
From: Press Releases of Ministry of Health and Welfare