Korean medical device companies Abbott Laboratories. This process ensures that all medical devices available in the market meet Feb 2, 2024 · Mastern America, the US subsidiary of local asset manager Mastern Investment Management, has joined hands with Hironic, a Korean medical device company, to expand its presence in the US market. Medical Device Regulations Medical Device Act (MDA) Enforcement Decree of MDA Oct 26, 2024 · The US remains the largest medical device industry in the world, with about 40% share of the global medtech market. We selected these startups and Sep 4, 2018 · “Korea has the world’s ninth largest medical device market but the technological superiority of Korean firms is not well known,” Lee said in the Korea Times report. However, Korean medical device companies are mostly small, and the market for such devices has not yet become international; thus, growth is limited. Medical Devices companies in South Korea are known for their innovative and high-quality healthcare products. 4 million in 2024 and is expected to reach USD 1,616. Info Web Phone Seoul #402 2/7 305-26 Shinrim 10 Dong Gwanakgu Seoul Seoul Ambulatory Product Medical Ware Other Networking Devices Noise As a tech hub, the South Korean medical device market has developed a sizable local industry but still relies on foreign manufactures for over half of their medical device needs, specifically high-end. We have always devoted ourselves to research and development for more than 10 years for innovative vascular intervention solutions such as the drug-eluting coronary-artery stent, considering the May 13, 2020 · The growing number of South Korean medical device manufacturers exports various medical devices, such as ultrasound imaging systems, dental implants, and implant superstructures, dental X-ray systems, soft contact lens, medical image devices, IVD reagents, biomaterial graft and prosthesis, and many others. The leading medical device company in South Korea in 2023 had a market share of 21 percent, far ahead of its competition. Aug 28, 2024 · Gross margin and net margin of top medical device companies 2014; Smart blood pressure monitor market size in China 2013-2018; Medical device imports to the U. Our goal is to build sales growth and establish brand value. Directory of Korean Biotech Companies. S. V31 TN36. KOREA MEDICAL DEVICE COMPANY. 67 trillion KRW and 3. Jul 1, 2005 · Medical device companies often consider the following two options when deciding whether to apply for Korea medical device reimbursement. Tel : +82 70 8080 4576 Whatsapp : +82 10 2154 7766 Fax : +82 50 4211 8870 Address : 100, Art center-daero 168beon-gil, Yeonsu-gu Jan 9, 2025 · Detailed info and reviews on 10 top Medical Equipment companies and startups in South Korea in 2025. 5 percent. 331 trillion KRW, respectively. a global medical device marketing and distribution company with deep clinical knowledge Panacea Company members share industry network and clinical knowledge to identify innovative medical devices, match them with unmet clinical needs and add value through professional marketing and global distribution. Key figures and rankings about companies and products Jul 1, 2024 · Top 12 largest South Korean Companies in the Healthcare sector by Market Cap. This report lists the top South Korea Endoscopy Devices companies based on the 2023 & 2024 market share reports. She joined Asia Actual as a partner in 2015. These startups and companies are taking a variety of approaches to innovating the Medical Device industry, but are all exceptional companies well worth a follow. To successfully market medical devices in the United States, European manufacturers must comply with the unique regulatory requirements of the U. Tried and tested selection of medical devices to suit our customer needs. ie. KMDICA is an organization under the auspices of the South Korean Ministry of Health and Welfare, which consists of […] KMD Indonesia (Korea Medical Device Indonesia) is a representative of the association of South Korean medical devices companies in Indonesia for the Korea Medical Devices Industry Association (KMDICA) based in South Korea. Jul 31, 2021 · This article showcases our top picks for the best South Korea based Medical Device companies. Some key segments in the industry include MRI devices, soft contact lenses, knee joint prostheses, CT systems, intravascular catheters, sight corrective ophthalmic lenses, and dialyzers for hemodialysis. The medical device industry in South Korea largely comprises small- and medium-sized companies (SMEs), which cannot exercise their self-sustaining power because they remain under political protection and have been negligent in their growth and development. Stepes’ ISO 13485-certified medical device translation solutions are technology-enabled to streamline the localization process for digital health devices, implantable devices, surgical devices, imaging systems, diagnostics, medical equipment, wearable devices, and remote monitoring systems to deliver measurable linguistic and technical quality and accuracy. These companies are involved in the manufacturing and distribution of a wide range of medical devices, including diagnostic imaging equipment, surgical instruments, dental equipment, and other medical devices. 3M in revenue. Email: [email protected] Phone: 00 353 68 22838 https://listal. MEDMONTS is a nine-year-old consulting company easing certification for medical devices. First, a medical device company can attempt to obtain reimbursement approval, but will take the risk of price reduction and perhaps limited indications. by country share 2014 Manufacture & Export of Injection Needle, Polypectomy Snare, Radiopaque Marker Company Introduction MENFIS KOREA is a medical device manufacturer in Korea. With 50 years of experience, we partner with medical device companies to promote and distribute their products. Aug 25, 2021 · 1. 6M in revenue and InBody with $126. Phone: 02 6260 1003 Fax: 02 6260 1156 https://www Top 3 Korean orthopedic implant companies. This report lists the top South Korea Ultrasound Devices companies based on the 2023 & 2024 market share reports. Foreign medical companies without their own local Korean office and who do not want to use their distributor as their local agent can have an independent ICC in South Korea maintain their product registrations in the name of the foreign manufacturer. They support all aspects of regulatory compliance, from initial setup of QMS to enhancements, audit preparation, and addressing findings. ” Top 10 Medical Devices & Equipment manufacturing companies in South Korea by revenue for August 2024 Listed below are the leading companies in South Korea by revenue as of August 2024. You can see the list below; Accuresearch Korea Address: 4F Daejung Bldg. Tel: +353 (0)74 974 0200 https://www. We source from the main pharmaceutical and biological laboratories in the country, and we supply foreign private health companies, state-owned ones and public health Sep 16, 2024 · It is the second largest medical device manufacturing industry in the United States, and also ranks among the top states with FDA-registered medical device manufacturing facilities. Medical Device Companies in Kerry Listal Ltd. 05 (2020), 1,144. The present import dependence of the Korean medical device industry is approximately 63%. KMDICA is an organization under the auspices of the South Korean Ministry of Health and Welfare, which consists of […] Dec 3, 2021 · Korean medical device companies have limited resources also explains why they have. 1ST Biotherapeutics : Korea - Gyeonggi-do Jul 31, 2021 · This article showcases our top picks for the best South Korea based Medical Device companies. is a specialty distributor and sales team for hire in the medical device industry. U. The Medical Devices market in South Korea is projected to grow by 7. Information about the domestic Sep 14, 2024 · South Korea, known for its advanced healthcare system and technological prowess, has a robust framework for regulating medical devices. In June 2023, President Yoon Suk-Yeol highlighted ways to export more Korean biotechnologies to the global market at the Fifth Export Strategy Meeting. The South Korean medical device regulatory framework is based on the Medical Device Act, Enforcement Decree of the Medical Device Act, the Enforcement Regulation of the Medical Device Act, as well as other corresponding regulations. These events will be held in conjunction with AACC 2023 Expo. Top 10 medical device companies in the US include global medtech powerhouses such as Medtronic, Johnson & Johnson, Abbott, Stryker, GE Healthcare, BD, Baxter, Cardinal Health, and Medline Industries. KOA Corporation is a full-service supplier to the world of medical devices, equipment and medicines developed and manufactured with top-quality standards in South Korea. Get the latest updates on their products, jobs, funding, investors, founders and more. The South Korea cardiovascular devices generated a revenue of USD 1,090. The framework for medical device approval in Korea is designed to ensure safety and efficacy, aligning with international medical device companies when they plan to partner with global medical device companies. In South Korea, medical devices are classified into four distinct categories based on their risk level, which directly influences the regulatory requirements they must meet. In 2019, total medical device imports were estimated at US$3. Orange County in Southern California, is a major medtech hub in the state, while other major hubs include Los Angeles, San Diego County, and Silicon Valley. 7 billion with US companies holding about 47% of this market. READ: Full List of Medical Device Companies in Sydney, NSW ; Medical Device Companies in Victoria. In July 2024, the South Korean government collaborated with the beauty sector to improve the small and medium-sized enterprises (SMEs) in the K-beauty sector. Hammtek Korea, Inc. dollars) [Graph], MFDS (South Korea), May 28, 2024. Get access to Lusha's database of business leads from medical equipment manufacturing companies in South korea. ,ltd. Manufacture & Export of Sungshim Medical Co. Korea’s medical regulatory system can be complicated for Western medical device manufacturers due to its increasingly strict requirements and Korea’s unique business culture. In terms of sheer number of medical devices, Florida is the fourth-largest state after California, Minnesota, and Massachusetts. ENFORCEMENT RULE OF THE ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES(20201231) 체외진단의료기기법 시행규칙(20201231) Note: MFDS offers the English version as a service to an international audience. “We highly recognized the potential of the Korean market so we held the conference here in Korea. , Ltd is the Korea medical device manufacturer specializing in high quality since Sep 1995. The Korean government has been ambitious and remarkably on 22 May 2019 President Moon Jae-in announced Vision 2030 to promote the medical device industry. As it is necessary to compare the growth of the IVD companies with that of large medical device companies in Korea, three largest listed non-IVD medical device companies in terms of revenue, Osstem Implant, Dentium, and Lutronic, are initially selected. of Korean medical device companies 01 04 02 05 03 06 Right Path Management Creativity beyond Imitation Glottalization with Customers Creation of the fuure Talent-first Policy Aimed at World's Top The World’s Best Medical Device Company. Abbott Ireland Diabetes Care Donegal Town Donegal Ireland. greater needs for open innovation [36]. Introduction. We tried to pick companies across the size spectrum from cutting edge startups to established brands. We take a look at the current state of manufacturing in South Korea, and what increased investment could mean for the country’s medical device industry. 8 million by 2030. joined the first batch of innovative medical device companies certified by the Ministry of Health and Welfare (MOHW) on Dec. It had a value of $3. Korea’s medical device regulatory structure Medical devices and IVDs in South Korea are regulated by the MFDS. In 2010, Sarah founded INTER MD, Inc. Read more Korean Digital Healthcare Company Wins CES 2020 Innovation Award for its Smart Belt Medical device regulations in South Korea are overseen by the Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), under the Medical Device Act. This collaboration aims to strengthen the country’s position in the global beauty market. Information regarding the medical device (including information on the approval, certification, and notification of the medical device) 3. Insights about top trending companies, startups, investments and M&A activities, notable investors of these companies, their management team, and recent news are also included. Jun 16, 2024 · Medical Device Companies in New South Wales. In terms of segment, surgical devices was the largest revenue generating Jun 27, 2024 · In 2023, the most valuable export destination for South Korean medical devices was the United States, with exports being valued at around 894. USA - BPG: This is a Premium Listing - upgrading may double or triple your referrals. Get access to the business profiles of top 10 South Korea Dental Devices companies, providing in-depth details on their company overview, key products and services, financials, recent South Korea is interested in developing a more robust clinical trial environment for medical devices and pharmaceuticals. 식품의약품안전처 희망의 새시대. We selected these startups and We are drastically investing in research and development in the orthopedic medical device market to equip the best technology and quality competitiveness, and we are also constantly striving for orthopedic medical device localization and to advance to global medical device markets. Medical Device Companies in California Jun 28, 2024 · The Global Medical Device Market Size, Top Medical Device Companies Ranked (2024) Bone Wax: Important Clinical Applications in Surgery, Side Effects; Full List of Medical Equipment Suppliers in Jamaica (2024) Full List of Medical Device Companies in Tunisia (2024) Full List of Medical Device Companies in Algeria (2024) What is Surgicel? Jul 21, 2023 · Korea Health Industry Institute (KHIDI), a government organization in the Republic of Korea, has announced a plan to host events supporting Korean medical device companies in their entry into the North American market. We, MEDMONTS, provide one-stop consulting service for Medical Device Manufacturers from testing to certification covering CE, FDA 510(k), Health-Canada, J-PAL, NMPA, and MFDS(KFDA). KMD Indonesia (Korea Medical Device Indonesia) is a representative of the association of South Korean medical devices companies in Indonesia for the Korea Medical Devices Industry Association (KMDICA) based in South Korea. First, considering that Korean medical device companies are still catching up with the status Dec 1, 2018 · In 2015, the market size of Korea's medical device industry was 5. This is because medical device manufacturers in Korea are mostly SMEs that have limited budgets for investing in improving product performance or securing reliability. in Korea and Dec 5, 2023 · As Korea becomes a leading exporter of medical devices, the Korean government is also trying to support domestic medical device companies interested in expanding to the global market. 58 Maryborough Street Fyshwick ACT 2609 . Class I Prepare Pre-Market Notification including basic device information. Publishing a white paper of Korean medical device industry Publishing regularly an analysis report on Korean/overseas medical device market and policies Conducting research service tasks assigned by the government and institutions 04 Research in Policy of Medical Device Industry Korea Medical Devices Industry Association Headquartered outside of Boston, MA, MEDIcept has supported domestic and international MedTech companies with their regulatory, quality, and clinical services for three decades. Medical Device consulting services - regulatory and quality - FDA, CE marking, ISO 13485, MDSAP, biological and clinical evaluation. 42 (2021) *Market size = Production – Export + Import. N. Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The industry has an expected annual “CAGR” of 5. Mordor Intelligence expert advisors conducted extensive research and identified these brands to be the leaders in the South Korea Endoscopy Devices industry. Jun 7, 2024 · Medical Device Companies in Donegal. Try it out. The listing should include: 1. subsidiary. 2655 trillion KRW, with exports and imports amounting to 3. Medical Device Companies in Florida Jun 20, 2024 · *Exchange rate: $ = 1,165. , Ltd In-house manufacturing of medical devices in partnership with top MedTech companies from South Korea Collaboration with competent medical technology specialists and skilled practitioners New product May 7, 2024 · The medical device industry is worth $40 billion in 2021. We have compiled a list of the best Korean orthopedic implant companies to help you make better strategic decisions. READ: Full List of Medical Device Companies in Melbourne, VIC; Medical Device Companies in ACT Aidacare. The requirements for regulatory approval in Korea include both a device approval as well as a quality system certification, known as Korea Good Manufacturing Practices (KGMP), specified in the Medical Device Manufacturing and Quality Control Standards (similar to ISO 13485:2016). These characteristics require Korean medical device. 1B in revenue, Smith & Nephew Korea is ranked first on the list, followed by Aed with $161. Mar 3, 2023 · India has a rapidly growing healthcare industry, driven by an increasing demand for medical devices and services. We started from the awareness of the problem which is the lack of infrastructure for manufacturing medical devices in Korea. List of the best Korean medical equipment manufactures. 65 (2019), 1,180. 7% between 2021 and 2026, driven by factors such as a rising geriatric population, increasing prevalence of chronic diseases, and a growing focus on healthcare infrastructure Apr 2, 2019 · Global medical device companies have established incubation centers or venture capital to foster start-ups and to promote innovation. 49% (2025-2029) resulting in a market volume of US$10. Information regarding UDI 2. Medical Device Classification System. Find your orthopedic devices from the leading brands. Sep 27, 2024 · California is home to most of the medical device companies in the US’s $182 billion medtech industry. 1, being categorized as an innovative takeoff-type business. South Korean firm picks Montgomery County over New York, Boston for site of U. KOL Bio-Medical Instruments, Inc. S Development Co. Now, the South Korean Government is looking to use this increased trust in Korean-made devices to boost the country’s medical device industry. 9%, with exports increasing by 8. Get access to the business profiles of top 10 South Korea Dental Devices companies, providing in-depth details on their company overview, key products and services, financials, recent Nov 5, 2024 · For foreign medical device companies, understanding these requirements is crucial for successful market entry and operation. If you have no local office in South Korea, you must appoint a Korea In-Country Caretaker (ICC) based in Korea to manage your medical device registration with the MFDS. Yeongdeungpo-gu, 07327, Seoul Jan 30, 2024 · The medical device company expects to have 20 employees in the Montgomery County office by year's end. In addition to medical device registrations, Sarah’s expertise encompasses KGMP audits and reimbursement applications. Listowel Business Park, Listowel, Co. As the market grows, understanding Korean medical device regulations is crucial for manufacturers looking to enter this lucrative space. Government policies and funds are in place to further boost the competitiveness of its medtech sector by highlighting the development of innovative and high-end medical devices. Whether you are a domestic manufacturer or an international company looking to bring your products to South Korea, understanding the registration process is crucial for compliance and market access. This blog provides an overview of the regulatory processes Nov 27, 2018 · companies in Korea, however, the actual sales of medical devices in 2017 was KR W 5. the integrated information system of medical device, etc. The South Korea market is expected to grow at a CAGR of 6. Moreover , the number of workers South Korea is interested in developing a more robust clinical trial environment for medical devices and pharmaceuticals. Global Pharmaceutical Companies in South Korea. 5 million U. In terms of segment, surgical devices was the largest revenue generating Armed partners with the best Korean medical device manufacturers to provide clients with unrivaled service and reach around the world. This entity is called the In-Country Caretaker (ICC). However, the R&D expenditure of all Korean medical device companies is less than 25% of that of a single foreign company. The medical device market in India is projected to grow at a compound annual growth rate (CAGR) of 15. Medical device registration in South Korea has a similar formatting to the European technical file/design dossier and 510(k) applications. 161 Waryong-dong Jongno-gu Seoul, Seoul korea May 9, 2024 · The medical device sector in South Korea moved from $8. Many Korean orthopedic device companies are looking to increase their share of the growing market. Kerry, Ireland. Armed partners with the best Korean medical device manufacturers to provide clients with unrivaled service and reach around the world. Korea’s medical device market is expected to maintain its current level of growth from now through 2018. ie/ Medical Device Companies WellsCare, a member of Born2Global Centre, became the first Korean medical device company to launch a product, the IASO, on major American electronics distributor Best Buy. This is the list of the largest public listed companies in the Healthcare sector from South Korea by market capitalization with links to their reference stock and industry. Top 10 Medical Devices & Equipment manufacturing companies in South Korea by revenue for August 2024 Listed below are the leading companies in South Korea by revenue as of August 2024. We are one of leading manufacturers and exporters of sterile single-use syringe, needle and insulin syringe, filter needle, insulin pen needle etc. 0 billion in 2021 to $9. South Korea cardiovascular devices highlights. Mordor Intelligence expert advisors conducted extensive research and identified these brands to be the leaders in the South Korea Ultrasound Devices industry. 5 per cent from 2022 to 2027. Mordor Intelligence expert advisors identify the Top 5 South Korea Dental Devices companies and the other top companies based on 2024 market position. ) of the Medical Device Act Enforcement Regulation. Aug 4, 2020 · South Korea has gained attention for its approach to controlling the Covid-19 pandemic. Dec 1, 2018 · In 2015, the market size of Korea's medical device industry was 5. Apart from the medical device parks, there are also government initiatives like the ‘Production Linked Incentive (PLI) Scheme for Medical Devices 2020’ to improve the medical device manufacturing capacity in India. abbott. [Online]. Japan is home to the largest US medical device companies like 3M, Edwards Lifesciences, Medtronic, GE Healthcare, Johnson & Johnson, Abbott, Stryker, and Zimmer. May 10, 2013 · The medical device market in Korea is growing quickly, at an annual average rate of 13. Mar 14, 2023 · In order to submit a clinical trial application for a medical device in Korea, foreign companies must first prepare a clinical investigation plan, along with documents proving that Good Manufacturing Practice (GMP) standards are met by the foreign company’s manufacturing facility. 2%. companies that require clinical trials for their medical devices and are interested in accessing Korea’s excellent hospital networks and physicians can contact the Medical Device Policy Division of the Ministry of South Korea is interested in developing a more robust clinical trial environment for medical devices and pharmaceuticals. 9% from 2025 to 2030. VUNO Selected as a Korea Innovative Medical Device Company South Korean artificial intelligence (AI) developer VUNO Inc. Founded in 2007, Curaco spent 17 years developing Carebidet, which was officially launched last year in Korea, the United States, and Japan. Genoss is a Korean medical device manufacturer that provides products and services for patients suffering from cardiovascular and vascular diseases. About Us The BCG medical device expert group is a skilled team proficient in various regulations in South Korea and other countries. Your Vision, Our Future Korean Medical Device Ministry of Food and Drug Safety 02. Internationally Aligned Medical Device Regulatory System Korean regulatory systems, harmonized with the global regulations, allow MFDS to manage the medical devices more effectively. . market, which differ significantly from the European framework May 27, 2024 · There are also initiatives to establish medical device parks in Tamil Nadu, Himachal Pradesh, Madhya Pradesh, and Uttar Pradesh. Covid-19 has brought unprecedented opportunities to Korean Jun 27, 2024 · Leading medical device exporting companies in South Korea in 2023, based on export value (in million U. 82 trillion, a year-on-year increase of 3. 2 billion in 2022. 1146 in-depth research reports on the Medical Devices market with historical data since 2018 and industry forecast till 2028, including detailed analysis of 146 companies. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; View full profile However, the current medical device industry is monopolized by global companies with capital and technological prowess. Any company looking to register medical devices in South Korea must adhere to the MFDS’s stringent requirements. 178 companies are listed in our database (showing 1 - 99) A. Top 5 Cosmetic Companies in South Korea: Procter & Gamble Company Area of Competency Sample of our Portfolio ; Biocompatibility : ISO 10933 series, ISO 18562: Electro-medical devices : IEC 60601 series, IEC 61010 series Jun 12, 2024 · A new development from the South Korean medical device company Curaco offers a solution: Carebidet, a robot designed to manage the excretory needs of elderly and bedridden patients. Medical Device Market Growth and Trends. ARC-Korea will become the world class company based on the Sep 1, 2023 · For a structured comparison, this study took the following selection process. companies that require clinical trials for their medical devices and are interested in accessing Korea’s excellent hospital networks and physicians can contact the Medical Device Policy Division of the Ministry of In South Korea, the holder of a medical product registration must be a Korea-based entity. in Seoul, Korea, to help medical device companies access the Korean market. With $4. To overcome this, Korean medical device companies are developing innovative medical devices centered on start-ups, but now is the time to strategically respond to them in order to compete with global companies. The Ministry of Food and Drug Safety (MFDS) is the primary regulatory body in South Korea responsible for overseeing the safety and efficacy of medical devices. Worry no more, this article brings out the top Korean medical and health equipment manufacturers with their contact addresses for easy access and communication. Dec 2, 2024 · South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. 219 in-depth research reports on the Diagnostic Devices market with historical data since 2018 and industry forecast till 2028, including detailed analysis of 39 companies. The statistics from KMDIA’s annual report on the Korean medical device market reveal a steady growth trajectory, despite a minor decline in market size in 2020. Info Web Phone Seoul 149-8 Yumri-dong Mapo-gu Seoul 121-872 Health & Medical Other Networking Devices Noise Reduction Device Agency Services Business Services Rsk Med Technologies Co. 9 billion in 2012, making it the third largest medical device market in Asia. Mar 22, 2008 · This list of companies and startups in South Korea in the medical space provides data on their funding history, investment activities, and acquisition trends. 20bn in 2029. vanct zgqv faceh xzc taur sduqtz zjsg bgvi rxjhwa ccyrcyq