New Legislations in South Korea to Provide Patients with Earlier Access to Breakthrough Medical Technologies

Beginning May 1, 2020, South Korea is rolling out a few brand-new legislations to support breakthrough medical technologies gaining earlier access to patients. Those new legislations will introduce to companies submitting breakthrough medical technologies, such as SaMD artificial intelligence (AI) presenting potentials for significant improvement of safety and effectiveness or novel treatments for rare diseases, various special regulatory or reimbursement programs for earlier market access. New regulatory programs will offer innovative medical technologies ample opportunities to special designations to breakthrough technologies, fast track review, partial exemption of pre-market requirements in exchange of post-market surveillance programs, acceptance to in-house standards or specifications, etc. In combination with breakthrough technology programs already introduced in the National Health Insurance in 2019, the new regulatory legislations, breakthrough technology suppliers will be able to pursue new opportunities for breakthrough devices. This session will highlight what’s new and how to take advantages of those new legislations and policy directions.

- Medical Devices Industry Promotion and Innovative Medical Devices Support Act: Special Act what’s new and how to advantage of those new legislations:
- In-Vitro Diagnostics (IVDs) Act
- Breakthrough Technology program in the New Health Technology Assessment (nHTA)

Agenda:

Introduction: Major changes in laws and regulations in 2020 for breakthrough devices
Young Kim, CEO & Principal Consultant, Synex Consulting Ltd.

Digital Health: MFDS is setting up its new office and pre-/post- market approaches
Young Kyu Kang, Deputy Director, Division of High-Tech Medical Devices, Ministry of Food and Drug Safety

Breakthrough Devices: Special programs by Innovation Support Act
Seung Hwan Jung, Deputy Director, Division of High-Tech Medical Devices, Ministry of Food and Drug Safety

IVD: Demystifying the new IVD Act in Korea
Young Wook Ahn, Deputy Director, Division of In Vitro Diagnostics Devices, Ministry of Food and Drug Safety

A New Option for Breakthrough Technologies: How to optimize earlier market access
Rachel Chung, Managing Director, Medical Device Division, Synex Consulting Ltd.

Closing
Young Kim, CEO & Principal Consultant, Synex Consulting Ltd.