【Health and Welfare News】 The Ministry of Health and Welfare (Minister Cho Gyu-hong) has issued part of the “Rules on New Medical Technology Evaluation” to strengthen safety management of advanced medical technologies, establish regulations on the basis for re-evaluation of new medical technologies, and extend the period for technologies with deferred evaluation. It was announced that the amendment will be announced from October 29 to December 9.
In the meantime, the Ministry of Health and Welfare has continuously improved the new medical technology evaluation pre-entry system to enable early use of excellent medical technology for patient treatment. However, due to the nature of pre-entry technology for which new medical technology evaluation has not been completed, opinions have consistently been raised that safety management during use should be strengthened and the pre-entry period (evaluation deferral of 2 years) should be extended to create sufficient clinical evidence.
The pre-entry system is a system that allows the field use of the technology first and evaluates new medical technology after the end of the period, and applies to deferred evaluation of new medical technology, innovative medical technology evaluation, limited medical technology evaluation, etc. (Article 2 (2) of the Rules, Article 3) Paragraph 11)
Accordingly, the Ministry of Health and Welfare developed innovation measures discovered at ▲biohealth new market creation strategy meeting (‘23.2.), ▲regulatory innovation strategy meeting (‘23.3.), and ▲discussed at the pre-entry-post-evaluation system improvement public hearing (‘23.8.). Reflecting the contents, we plan to promote rule revisions to simultaneously strengthen the safety of advanced technologies and encourage companies to enter the market.
Ensuring the safety of technology >
The safety management system is strengthened by making it mandatory to obtain patient consent and report usage status when using advanced technology.
Pre-entry technologies reported by the evaluation committee to have a high level of risk will be discontinued, and technologies with safety issues will be eliminated.
In case there are concerns about the safety of medical technology or the effectiveness changes, provisions will be prepared for the re-evaluation of medical technology and periodic management of the usefulness and value of the technology will be promoted.
Facilitating market entry of technology >
Expand the scope of deferral of evaluation to all non-invasive medical technologies to promote market entry of various medical technologies.
The period of use of deferred evaluation technologies will be extended up to 4 years (extended once), and advanced medical technologies that are applying for new medical technology evaluations will be allowed to continue to be used until the results are notified, thereby supporting continuous clinical use of the technology.
Kim Kuk-il, Director of Health and Medical Policy at the Ministry of Health and Welfare, said, “After the revision of the ‘Rules on New Medical Technology Evaluation’ in 2022, we prepared this system improvement plan by reflecting the opinions raised by the medical community, industry, and civic groups and the difficulties in the field.” , “We expect that we will be able to quickly utilize excellent technologies in the market while strengthening the safety management of advanced medical technologies,” he said.
