1. Reason for proposal

The aim is to expand opportunities for medical technologies with low worries of stability to enter the medical field first in order to protect people’s health and encourage the development of medical technologies.

2. Main content

A. The subjects for the postponement of new medical technology evaluation are increased, the period is extended, and the condition for postponement is eased to expand opportunities for first entry into the medical field (Article 2 of the draft).

B. Basis acts and subordinate statutes are improved and embodied in relation to the configuration and review of sub-committees and other committees under the New medical technology evaluation committee (Article 3 of the draft).

C. Regulations on the management of adverse events of evaluation-deferred new medical technologies, temporary medical technologies, and innovative new medical technologies available in the medical field are embodied (Article 3-3 of the draft).

D. Other insufficiency in acts and subordinate statutes is supplemented (Article 6, Article 9, and Article 10 of the draft).