(1) Reasons for Proposal
After a company who developed a new medical device received marketing approval following successful clinical trials, latecomers are approved without clinical data; it is necessary to improve some of the weaknesses that have emerged in the operation of the current system, such as the improvement of the clinical data review system.

(2) Major Provisions
A. Designating and announcing the product items subject to technical document review for the improvement of the essential equivalence system, the amendment aims to clearly specify the objects and scope of the submission of clinical data when seeking marketing approval and strengthen the validation of safety and efficacy if a product item is subject to clinical data submission (Article 2, Article 3, Article 6, Article 23, Article 28, Article 34, attached Table 5, attached Table 6, attached Table 7, attached Table 8, attached Table 8-2, attached Form No. 3, and attached Form No. 5).

B. The clinical trial data of equivalent products were allowed only for existing classes 1 and 2, but such allowance shall be expanded to class 3, and the clinical trial data only listed in the Science Citation Index (SCI) were allowed, but it shall be extended to Science Citation Index Expanded (SCIE) (Article 29, subparagraphs 1 and 2 and Article 33).
C. The amendment aims to increase the convenience of consumers by expanding the list of medical devices subject to the exemption from reporting a sales business from existing “for pregnancy diagnosis” to “for identifying ovulation period” (Article 55).