[ Press Release, May 20, 2020 / unofficial translation ] Domestic Medical Device Production Records Reach 7 Trillion Won - Increase in demand for dental implants and multifocal intraocular lenses due to aging population - □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) announced that the production records of medical devices in 2019 reached 7,279.4 billion won, which is an increase of 11.8% yoy(6,511.1 billion won). ○ The production of medical devices has been showing a growth trend for the past 5 years averaging 9.8% each year, exceeding about 5 times of the 2019’s real GDP growth rate of 2.0%. * 2019 real gross domestic product (GDP) growth rate: 2.0% (Bank of Korea economic statistic system) ○ Exports and imports have also increased by 8.9% and 13.3% respectively compared to the previous year*, showing the domestic medical device industry’s growth trend across the production, export and import sectors. * (Exports) 2018: 3,972.3 billion won → 2019: 4,279.1 billion won (Imports) 2018: 4,324.5 billion won → 2019: 4,849 billion won □ The market size of the domestic medical device* has been expanding by an annual average of 10.3% for the past 5 years, reaching 7.8 trillion won in 2019. * Market size: Production + imports - exports (market size calculations use KRW figures < Stable No.1 Product Among Medical Devices: Dental Implants > □ Looking at medical device production numbers by products, dental implants* ranked first (1,362.1 billion), followed by ultrasound imaging systems* (470.6 billion) and dermal filler (243.5 billion), with the top 10 items accounting for 41.1% (2,995.3 billion) of total production. * Dental implants: dental implant fixtures + abutments * Ultrasound imaging systems: General ultrasound imaging systems which transmit ultrasound to an affected area and receive reflected signals, turning them into an image ○ The products with the highest increasing rates yoy in production amount were dental CT systems*(75.3%) and dental implants (26.9%). * Dental CT system: An equipment which obtains tomography of teeth, chin, etc. by digitizing the signal of projected X-rays using semiconductors and others. - In particular, dental implants ranked the 1st place in production volume for three consecutive years, of which the causes seem to be an aging population and an expansion of health insurance coverage. ♣ Notes . Dental implant production amounts: (2017) 888.900 billion → (2018) 1,073.1 billion → (2019) 1,362.2 billion . Expansion of health insurance coverage on dental implants: (July 2016) the age of 70 → the age of 65, (July 2018) User-paid rate 50% → 30% . Dental implant surgery cases: (65 or older): (2017) 653,071 → (2018) 659,854 → (2019) 842,287 < Increase in Exports of Medical Devices Related to Aging and Cosmetic Treatments > □ Ultrasound imaging systems ranks first on medical devices for exports (561.5 billion) for three consecutive years, followed by dental implants (364 billion) and dermal fillers* (254.9 billion). ○ The product whose growth rate of an amount of export ranks first was dental implants (33.9%), with an analysis showing the increase in exports to China, Germany, and Romania. ○ In terms of amount of export, China ranked first (715.2 billion), followed by the US (675.6 billion) and Germany (276.3 billion). - Amongst the top 15 countries by exports, the exports of medical devices such as diagnostic X-ray imaging systems, personal heating devices, genetic testing reagents **, etc. to the UAE (161.1%), Vietnam (35.8%), and France (24.6%) surged. * official product name in the notification: Graft/prosthesis, biomaterial ** official product name in the notification: IVD reagents for infectious disease, nucleic acid test < No.1 Growth Rate of Imports: Multifocal Intraocular Lenses for the Improvement of Aging Sight/Cataracts > □ Daily soft contact lenses ranked first in the imports of medical devices for three consecutive years (177.1 billion). ○ Following the previous year, multifocal intraocular lenses (73.8%) showed the highest rate of increase in imports, which appears to have been influenced by aging society evidenced by a continuous increase in cataract surgeries, etc. ♣ Notes . Multifocal intraocular lens: A type of implant for vision correction to recover from nearsightedness/farsightedness by replacing the eye’s natural lens, completely relying on imports (the USA, Germany) . . Imports of multifocal intraocular lenses: (2017) 27.6 billion → (2018) 56.8 billion → (2019) 104.6 billion . Cataract surgery cases: (2017) 239,173 → (2018) 276,730 → (2019) 357,170 < Increase in Production and Exports of In Vitro Testing Reagents Expected > □ The 2019 production amount of IVD Reagents is 378 billion won, and its amount of export amount is 501.2 billion won, which decreased by 9.2% and 3.1% yoy respectively, while the amount of import increased by 11% to 512.8 billion won. ○ These are the records of 2019, before the outbreak of COVID-19, which do not include the production/import/export records of the COVID-19 testing reagents. - However, In Vitro Diagnostics is expected to grow further since it accounts for 5.2% of the total amount of production and 11.6% of the amount of export for medical devices last year, and reagents such as high-risk infectious agent immunity testing reagents* features in the top 30 in the amount of production and exports for two consecutive years. * High-risk infectious agent immunity testing reagents (IVD reagents for infectious disease marker): reagents for diagnosing sexually-transmitted diseases, fetal infections, infections of the cerebrospinal fluid and blood, and legally designated infectious diseases ○ Along with the explosive increase in demand for IVD Reagents for COVID-19 in 2020 and the establishment of the “Act On In Vitro Diagnostic Medical Devices” for the sake of securing the safety and strengthening international competitiveness of in vitro diagnostic medical devices, the size of the in vitro diagnostic reagent field is expected to increase further. □ Through last year’s enactment of the “Act on Support for the Promotion of the Medical Device Industry and Innovative Medical Devices” (Medical Devices Regulations) and the “Act on In Vitro Diagnostic Devices” the Ministry of Food and Drug Safety laid a foundation for the promotion of the medical device industry. ○ This year, the Ministry committed to do our best to support a quick commercialization of excellent medical devices and further enhance our public health with a full-scale implementation of the “Medical Device Regulations” and the “In Vitro Diagnostic Regulation.” □ Through last year’s enactment of the “Act on Support for the Promotion of the Medical Device Industry and Innovative Medical Devices” (Medical Devices Regulations) and the “In Vitro Diagnostics Regulation,” the Ministry of Food and Drug Safety laid a foundation for the promotion of the medical device industry. ○ This year, the Ministry committed to do our best to support a quick commercialization of excellent medical devices and further enhance our public health with a full-scale implementation of the “Medical Device Regulations” and the “In Vitro Diagnostic Regulation.”