South Korea National Companion Guide

• An entity that intends to conduct a clinical trial with a digital medical device shall prepare a clinical trial plan to be approved by the MFDS. The same applies to protocol changes.
• An entity that intends to conduct a clinical trial with a digital medical device shall conduct a clinical trial at a clinical testing center designated in accordance with Article 10(3) of the Medical Device Act.
• However, clinical trials falling under certain subparagraphs may be conducted at an institution other than the clinical trial site as prescribed by the Prime Ministerial Decree. In this case, the approval of MFDS must be obtained in advance, and the same applies to any changes to the approved plan. These situations include:
• A clinical trial where subjects can only be recruited from institutions that fall under any of the following sub-items:
  • Infectious disease management institutions designated pursuant to Article 36(1) and (2) of the “Infectious Diseases Control and Prevention Act.”
  • Medical institutions, isolation wards, nursing homes, or clinics that are designated, established, and operated as infectious disease management institutions pursuant to Article 37(1) of the “Infectious Diseases Control and Prevention Act.”

The Ministry of Food and Drug Safety (MFDS) regulates the safety of food, drugs, cosmetics, and medical devices to protect public health in South Korea. The Health Insurance Review and Assessment Service (HIRA) and the National Evidence-based healthcare Collaborating Agency (NECA) are the two primary entities DHT developers will engage with for product assessment, pricing, and reimbursement.

The health security system in Korea has two components: mandatory social National Health Insurance (NHI) and medical aid. NHI provides healthcare coverage to all citizens. The major sources of NHI funding include contributions from those who are insured and government subsidies. The medical aid program is a form of public assistance that uses government subsidies to provide low-income groups with healthcare services.

The Ministry of Health and Welfare (MoHW) oversees the NHI system and its two fundamental institutions: National Health Insurance Service (NHIS) and HIRA. NHIS serves as the insurer and HIRA conducts claims reviews, reimbursement determination for services and items (including medical technologies), and quality assessment of health care services.

In line with HIRA’s work, NECA is the national research agency that provides information about medical devices, medicines, and health technology through objective and reliable analysis. NECA contributes to the efficient use of national medical resources and the protection and enhancement of national health by proposing scientific evidence. NECA has two main bodies: the core research body, which focuses on health technology assessment (HTA) and collaboration research, and the Center for New Health Technology, which supports the Committee for New Health Technology Assessment.

A marketing authorization holder (MAH) must submit the medical device registration application(s) and hold the license thereafter. An overview of the medical device approval process can be found on the MFDS website. Nonetheless, the most up-to-date information can be acquired through your MAH, as they need to be in compliance with the local laws and regulations, or through a qualified medical device consultancy firm.

Product review timelines differ based on medical device risk classifications and pathways for a marketing authorization.

A sample conventional progression may include:

• Medical device approval by MFDS (80 days).
• Review of reimbursement eligibility by HIRA (30-60 days).
• New health technology assessment (nHTA) by NECA (140-250 days).
• Register for insurance benefit by the National Health Insurance Review & Assessment Service (100 days).

However, in practice, timelines may be significantly longer than what the statutory review periods state due to reviewers’ schedules.

NECA, aware of the medical device industry’s belief that the traditional review timeline is too long when conducted in sequence, implemented a simultaneous review of New Health Technology Assessment and Healthcare Coverage Determination to reduce the maximum duration from 490 days to 390 days. The goal of this process is to expedite the entry date of new health technology to the clinical environment, broaden the treatment choice of the patients, and contribute to developing and expanding the healthcare market.

General questions can be submitted to the FDA by email. The FDA aims to respond, or acknowledge receipt and provide a timeline for response, within 5 days of receipt.

Does the agency encourage a pre-submission OR scientific advice process or discussion? If yes, how does a company initiate this process?

Yes, the FDA encourages pre-submission discussion. Companies may contact the FDA through the Q-Submission Program, which is a pathway for receiving formal feedback from the FDA prior to product submission, either written or in a meeting. Please refer to the guidance document outlining the Q-Submission process.

The FDA’s main support structure for regulatory applications is through the Q-submission process, outlined above. The agency will engage with companies during the submission process as outlined in the guidance documents for each pathway.

The majority of applications can be submitted online through the FDA’s Center for Devices and Radiological Health (CDRH) portal. As of October 1, 2023, all 510(k) submissions must be made through using the FDA’s electronic Submission Template and Resource (eSTAR). At this time, De Novo requests may be made electronically through eSTAR or by mail through eCopy (instructions), while PMA submissions must be made through eCopy. Q-submission and Breakthrough Device Designation requests are also made through the CDRH portal.