South Korea

The Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), serves as the primary regulatory authority for health products in South Korea, encompassing pharmaceuticals, medical devices, diagnostics, and digital health solutions. The overarching legislative framework includes the Pharmaceutical Affairs Act for drugs and biologics, the Medical Devices Act for medical devices and in-vitro diagnostics, and the Digital Healthcare Act, which provides specific guidance for software-based health solutions. All health products intended for the Korean market must receive MFDS approval or certification prior to commercial distribution. The review process involves submission of a product dossier, scientific evaluation by MFDS or its affiliated reviewing bodies such as the National Institute of Food and Drug Safety Evaluation (NIFDS), and, where applicable, Good Manufacturing Practice (GMP) inspections of manufacturing sites.

Applicants seeking MFDS approval are generally required to appoint a locally registered representative or marketing authorization holder domiciled in South Korea, unless the applicant itself holds a domestic business registration. South Korea accepts dossiers structured according to the International Council for Harmonisation Common Technical Document (ICT-CTD) format for pharmaceuticals, and follows IMDRF guidance frameworks for medical devices, reflecting its active participation in the Global Harmonization Working Party lineage. Clinical data generated overseas may be accepted, but bridging studies or locally conducted clinical evaluations are often required to demonstrate relevance to the Korean population. Notably, recent regulatory reforms have introduced expedited pathways for innovative or urgently needed health technologies, including a Conditional Approval system and an Innovative Medical Device designation that can substantially shorten review timelines. The MFDS has also expanded its Digital Health regulatory sandbox program to facilitate faster market entry for AI-based and software-as-a-medical-device (SaMD) products.

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 oversees the national health insurance system administered by the National Health Insurance Service (NHIS). The Health Insurance Review and Assessment Service (HIRA) plays a central role in evaluating the clinical and economic value of health technologies for reimbursement listing, conducting Health Technology Assessment (HTA) reviews that are a prerequisite for products seeking inclusion on the National Health Insurance (NHI) formulary or reimbursement schedule. Public hospitals and national medical institutions procure health products through the Public Procurement Service (PPS), a centralized government purchasing agency that manages national supply contracts and tenders. Pricing for reimbursed pharmaceuticals is negotiated between manufacturers and the NHIS under a positive list system, while medical device reimbursement pricing follows a separate but similarly structured evaluation pathway. South Korea operates a predominantly single-payer public insurance model, meaning that NHI reimbursement listing is a critical commercial milestone for market access and accounts for the vast majority of volume in the public sector.

The private sector in South Korea is substantial and well-developed, with private hospitals and clinics representing a significant share of healthcare delivery and procurement activity. Private procurement operates through direct purchasing agreements between healthcare institutions and manufacturers or their local distributors, often at prices negotiated independently of NHI reimbursement rates. South Korea is a high-income country and is not a primary recipient of major donor-funded health procurement programs such as those administered by UNICEF Supply Division, the Global Fund, USAID, or Gavi; accordingly, these channels are not material pathways for health product market access in South Korea. The government maintains a preference for locally manufactured or domestically developed health technologies in certain strategic procurement categories, supported by industrial policy initiatives under the Korea Bio-Health Industry Promotion Act and related programs designed to foster domestic innovation and manufacturing competitiveness in pharmaceuticals, biologics, and medical devices.