Ministry of Health and Welfare begins major surgery on new medical technology evaluation system

(Health Korea News / Lee Si-woo) The government is significantly improving the new medical technology evaluation pre-entry system.

On the 29th, the Ministry of Health and Welfare announced a partial amendment to the ‘Rules on New Medical Technology Evaluation’, which includes strengthening the safety management of advanced medical technologies, establishing regulations on the basis for re-evaluation of new medical technologies, and extending the period for technologies with deferred evaluation.

The new medical technology evaluation pre-entry system is a system that first allows field use of the technology and then evaluates the new medical technology at the end of the period.

The Ministry of Health and Welfare plans to announce the amendment as legislation by Monday, December 9, and then confirm the amendment based on the collected opinions.

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 technologies for patient treatment. However, due to the nature of pre-entry technologies for which new medical technology evaluation has not been completed, safety management during use has been strengthened. Opinions have consistently been raised that the pre-entry period (2 years of deferral of evaluation) should be expanded to create sufficient clinical evidence.

Accordingly, the Ministry of Health and Welfare reflected the innovation measures discovered at the ▲ biohealth new market creation strategy meeting, ▲ regulatory innovation strategy meeting, etc. and ▲ the contents discussed at the public hearing on improvement of the pre-entry-post-evaluation system, to strengthen the safety of pre-entry technology and the corporate market. This amendment was prepared to promote rule revision to simultaneously achieve entry activation.

According to the amendment, the safety management system is strengthened by stipulating that obtaining patient consent and reporting the status of use are mandatory when using advanced medical technologies.

An exit mechanism was also prepared. 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 expelled.

The amendment establishes provisions for the re-evaluation of medical technology in case there are concerns about the safety of the medical technology or changes in effectiveness, and also promotes periodic management of the usefulness and value of the technology.

In particular, it was decided to expand the scope of evaluation deferment to all non-invasive medical technologies to promote market entry of various medical technologies. This is an expansion of the so-called advance entry system.

In addition, 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. did it

(Main contents of the amendment)

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.” He expressed his expectations for the amendment, saying, “While strengthening the safety management of advanced medical technologies, we will be able to quickly utilize excellent technologies in the market.”

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