A comparative study of regulatory perspectives on innovative medical devices in Korea and the United States

ABSTRACT

Introduction

As the 4th Industrial Revolution era emerges, medical devices that apply technologies such as big data, artificial intelligence, and 3D printers are on the rise. In April 2019, Korea introduced the Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices to shorten the market entry time by conducting step-by-step screening through the designation of innovative medical devices, priority screening systems, and special permission screening systems.

Areas covered

In this study, the Breakthrough Device Program of the United States, which has been implemented since 2016, and Korea’s innovative medical device designation system were compared.

Expert opinion

Compared to the United States, Korea seems complicated because it has one more step in reviewing the innovative medical device group, but in terms of content, the two countries designate innovative medical devices on a similar basis. Neither country has established properly innovative medical device health insurance. Thus, a new insurance benefit scoring system based on actual evidence will have to be established. The role of experts in analyzing these data will be important and the voices of both innovative medical device manufacturers and medical field experts must be accepted.

KEYWORDS:

• Innovative medical devices
• breakthrough device program
• regulatory procedures
• FDA guidelines
• Korea

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This research was supported by the Bio & Medical Technology Development Program of the National Research Foundation (NRF) & funded by the Korean government (MSIT) (No. 2017M3A9E9073680).