![]() ![]() With the implementation of the KORUS FTA, U.S. In addition to medical device approvals, companies need to negotiate pricing terms with the Korean Health Insurance Review and Assessment Service (HIRA).Ĭurrent issues facing the medical device industry in Korea include reimbursement pricing governed by the National Health Insurance (NHI), the new healthcare technology assessment system for medical devices, and the new regulation requiring devices to be registered every 5 years, which takes effect in 2025. As part of pre-market approval requirements, the Ministry of Food and Drug Safety (MFDS) requires testing reports on safety and efficacy. The importation of medical devices requires the assignment of an importer or representative based in South Korea to manage medical device approvals and to ensure regulatory compliance. medical device manufacturers should follow Korean government’s pricing and reimbursement policies as the country grapples with cost containment under its national healthcare system. Charged-particle accelerator for therapy.However, Korea recovered from its impact relatively in a fast manner and its total market size reached the record-breaking amount of $7.9 billion in USD in 2021. The total market size for medical device in Korea unprecedentedly decreased with -3.5 percent growth rate in 2020. The MFDS views this increase was brought by the surge in the export of diagnostic kits for COVID-19 in 2021. ![]() The total production and export amount by local manufacturers in 2021 also increased over 30 percent, recording $11.3 billion and $ 8.6 billion in USD respectively. China entered the third place with a narrow margin behind Germany, which decreased from 17.4 percent in 2020 to 14.8 percent in 2021. Its share in the medical device import market increased from 7.8 percent in 2020 to 12.3 percent in 2021. however, the share of Chinese medical device grew rapidly. The US medical device has been ranked in the first place over the past four years in the Korean import market, with its market share steadily maintained between 40 to 50 percent. Since the outbreak of COVID-19 in 2020, there are a few important changes in the landscape of Korean medical device market.Īccording to the Ministry of Food and Drug Safety (MFDS), the amount of import rose at 20 percent in 2021, contributing the record-breaking expansion of size for the medical device market in Korea. Source: MFDS (Ministry of Food and Drug Safety) (Total market size = (total local production + imports) - exports) Table: Medical Device Market Overview Table Economic Development Organizations (EDO).Foreign Direct Investment Attraction Events.Facing a Foreign Trade AD/CVD or Safeguard Investigation?. ![]()
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