Learn how TÜV SÜD can support the roll out of medical devices and IVDs in Korea with its Good Manufacturing Practice (GMP) Audit designation
Learn how TÜV SÜD can support the roll out of medical devices and IVDs in Korea with its Good Manufacturing Practice (GMP) Audit designation
With a population of over 50 million people, South Korea is one of the world's leading economic powers. As the elderly population increases, the country is spending more on healthcare than other Asian countries, such as Hong Kong, Singapore, and Taiwan. South Korea has become increasingly attractive to medical device manufacturers worldwide, as more than half of the approved medical devices are being imported from overseas.
Manufacturers and suppliers intending to sell or import medical devices in South Korea must first obtain approval from the Ministry of Food and Drugs Safety (MFDS). Typically, both domestic and foreign manufacturers of imported medical devices are subject to GMP audit.
In South Korea, medical devices are categorized into four classes based on their level of risk, and procedures vary according to the class.
For medical devices classified as Class II, Class III, and Class IV, including those with new types of technology or new intended uses, the MFDS requires technical documents and clinical studies based on Safety and Efficacy Review (SER). For Class III and IV medical devices, the MFDS directly reviews the submitted files. For Class II medical devices, a third-party organization approved by the MFDS conducts the review on the Ministry’s behalf. Regarding the functionality, safety, and efficacy of medical devices, it is mandatory to obtain test reports from MFDS-approved testing laboratories and submit them.
The Medical Device Good Manufacturing Practice (GMP) Audit is an assessment conducted to determine whether medical devices can be guaranteed consistently high-quality production, ensuring they are safe, effective, and suitable for their intended purpose.
TÜV SÜD Korea has been designated as a GMP organization for medical devices and in vitro diagnostic medical devices by the MFDS in accordance with relevant regulations.
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Since 1992, TÜV SÜD has been providing services in Korea through its branch offices in Seoul and Busan and testing facilities in Guro-gu, Seoul. Medical device experts at TÜV SÜD Korea have the extensive knowledge required for entering the South Korean market, as well as a thorough understanding and experience regarding relevant regulations. They facilitate efficient communication with regulatory authorities and local representatives of manufacturers in South Korea.
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