[의료기기] President Moon Jae-in announces measures to reform the regulation of the medical device industry

July 19, 2018, announcement of regulatory innovation and promotion of the industry in the medical device sector

– The significant policies are summarized below.

(1) In vitro diagnostic devices, pre-authorization prior to regulation – transition to the post-regulation stage (completely negative)

– Step-by-step transition to the post-evaluation method. The period of entry into the market is shortened from 390 days maximum to less than 80 days. Implementation of Post-Infectious Disease Regulations (Target for January 2019) Expansion of all elements (planned for 2H09)

– Simplification of Licensing Procedures (Amendments, except Major Changes, Self-Management of Industry, Target for March 2019)

(2) Insulin-dependent diabetes (mainly type 1 diabetes and partial type 2 diabetes)

– The material of the insulin pump will be applied from August 2018. The continuous measurement materials of blood glucose will be developed according to detailed standards. Continuous Glucose Monitor / Insulin Pump, Cash Benefit Review (Target, March 2019)

(3) Support the entry of advanced medical devices into the market

– Medical devices that promote the convenience and productivity of medical personnel are allowed to enter early, but the cost is imposed by the hospital. In addition, the preliminary insurance codes (to serve as a reference on foreign markets, January 2019)

– Guidelines for the rapid registration of 4th industrial products, advanced medical devices, etc. (Target for August 2018) New Separate Track of Medical Technology Assessment (scheduled for January 2019)

Perspective of Analyst: Direction of the future regulation of the medical device industry

– Regulatory innovation can not be fast because the health care industry is concerned about people's health and lives. Until an invoice is actually created, it is likely that the time will be longer than expected. In addition, the health care industry is closely related to various government departments and regulatory agencies. The Ministry of Science and Technology, the Ministry of Industry and Trade, the Ministry of Health and Welfare, the Ministry of Small and Medium Enterprises, the Food and Drug Administration, the Fourth industry and major university hospitals. In addition, there are other related organizations, such as the Center for Examination and Assessment of Medicare and the Evaluation Committee for New Medical Technologies.

– However, in this situation, the president announced an innovation plan directly and put the emphasis on regulatory innovation.

– Regulatory Branch is important that the medical device industry is the regulatory industry. The future direction of regulation will likely be more streamlining of regulation than deregulation or disposal. As part of this regulatory innovation initiative, important alternatives have been announced for in vitro diagnostics, chronic diseases and productivity enhancing devices. Most were relatively less concerned about security issues. It is necessary to avoid the expectations of deregulation for the medical device industry as a whole.

– Related element: (1) Diabetes Associated Device: Isense (099190 / Buy / TP 30,000 won / Continuous Glucose), Io Flow (Unlisted Company / Insulin Injector) (2) Diagnostic Device in In vitro: / Not Rated), Seegene (096530 / Unbadessed), Zen Qrix (229000 / Unbadessed), (3) Advanced medical devices: Clexo (060280 / NotRated), Buneo (Unlisted) Inspection (unlisted company)