South Korea

The Ministry of Food and Drug Safety (MFDS), established as an independent agency in 2013 under the Framework Act on Food and Drug Safety, serves as South Korea's primary regulatory authority for pharmaceuticals, medical devices, in vitro diagnostics, and digital health products. The legal framework is anchored by the Pharmaceutical Affairs Act, the Medical Devices Act (amended 2019 to create a standalone regulatory category), and the Act on the Safety of and Support for Rare Diseases and Orphan Drugs. All health products must obtain MFDS approval or certification before commercialization, with review pathways differentiated by product risk class: medical devices are classified into Class I through IV, and pharmaceuticals follow new drug application (NDA) or abbreviated pathways depending on novelty and origin. The MFDS also operates expedited review tracks, including priority review designation for innovative or unmet-need products, conditional approval mechanisms, and a fast-track pathway for breakthrough medical technologies introduced under the 2020 Digital Health Care Act.

Foreign manufacturers seeking market authorization in South Korea must appoint a locally registered marketing authorization holder (MAH) or domestic agent who assumes full regulatory and post-market surveillance responsibility. Submissions generally follow the Common Technical Document (CTD) format, and the MFDS participates in the International Council for Harmonisation (ICH) and the International Medical Device Regulators Forum (IMDRF), facilitating alignment with global standards. Clinical data generated in South Korea is typically required for locally conducted bridging studies when foreign clinical evidence is considered insufficient for the Korean population. Recent regulatory reforms include the 2021 revision of the Medical Devices Act to create a dedicated regulatory framework for Software as a Medical Device (SaMD) and AI-based diagnostics, the introduction of the innovative medical device designation system, and expanded use of real-world evidence (RWE) in post-market evaluations. The MFDS has also strengthened its Good Manufacturing Practice (GMP) inspection regime and entered bilateral mutual recognition agreements with key trading partners to streamline conformity assessments.

Public procurement of health products in South Korea is primarily coordinated through the Ministry of Health and Welfare (MOHW), which sets national health policy and manages the National Health Insurance (NHI) system administered by the National Health Insurance Service (NHIS). The Health Insurance Review and Assessment Service (HIRA) conducts economic evaluations, including cost-effectiveness analyses, to determine reimbursement eligibility and pricing for pharmaceuticals and medical devices listed on the NHI benefit schedule. Pharmaceuticals must be listed on the National Drug Formulary through a formal health technology assessment (HTA) process that includes clinical and economic dossier review, with negotiated pricing conducted between the manufacturer and NHIS. Medical devices follow a separate benefit listing pathway under the NHI coverage assessment. Public hospital procurement is conducted through the Public Procurement Service (PPS), a government agency that manages centralized tendering for public institutions, and hospitals affiliated with national universities or government entities are required to procure through PPS-managed contracts. Pricing transparency and anti-corruption compliance are enforced under the Fair Trade Commission and MOHW guidelines, which prohibit rebate-based sales practices that were historically common in the sector.

The private healthcare sector in South Korea is substantial, with a large network of private hospitals and clinics that procure health products independently through direct negotiations with distributors and manufacturers, outside the centralized PPS framework. Private sector pricing is market-driven but influenced by NHI reimbursement benchmarks. South Korea is a high-income country and is not a primary recipient of donor-funded health procurement programs such as those administered by UNICEF Supply Division, the Global Fund, USAID, or Gavi; accordingly, international donor channels play a negligible role in the domestic health product market. However, South Korean companies and institutions actively participate as suppliers and implementing partners in global health initiatives. The government maintains policies that support domestic manufacturing through the Korea Drug Approval System and the Korea Medical Device Industry Association (KMDIA) framework, and recent industrial policy under the K-BIO initiative provides investment incentives for local pharmaceutical and medical device production, including tax benefits and expedited regulatory support for domestically manufactured innovative products.