OBTAINING MEDICAL DEVICE APPROVAL IN SOUTH KOREA
With more than 50 million people, South Korea is one of the world’s leading economic nations. Due in part to its aging population, South Korea already spends more on healthcare than its leading Asian neighbours, Hong Kong, Singapore and Taiwan. South Korea is an attractive growth market for medical device manufacturers from around the world, with more than half of all approved devices coming from manufacturers outside the country.
REGULATORY LANDSCAPE FOR MEDICAL DEVICES IN SOUTH KOREA
Manufacturers and suppliers who wish to sell or import medical devices in South Korea must first be approved by Korea’s Ministry of Food and Drug Safety (MFDS, formerly known as the KFDA). Companies not located in South Korea must appoint an importer license holder located in South Korea, who legally represents the company in all dealings with the MFDS. License holders are also subject to a good manufacturing practices audit, which generally follows the requirements of ISO 13485.
Medical devices in South Korea are assigned to one of four classes, according to the level of risk. Except for Class I devices, all medical devices require approval from the MFDS. For Class II, III and IV devices involving new types of technology or a new intended use, the MFDS requires the submission of a technical file and clinical studies as the basis for a Safety and Efficacy Review (SER). The MFDS reviews this documentation for Class III and Class IV devices, while MFDS approved third-parties can review technical documentation for Class II devices. Test reports prepared by MFDS approved testing laboratories on the function, safety and efficacy of the medical device must also be submitted.
WHY CHOOSE TÜV SÜD MALAYSIA
TÜV SÜD has operated in Korea since 1992, and maintains offices in Seoul and Busan, as well as a testing laboratory in Guro, Seoul. TÜV SÜD Korea is approved by the MFDS as a third party authorised to conduct technical file reviews for all product categories in Class II. Medical device experts at TÜV SÜD Korea also have extensive knowledge about current and prospective regulations affecting medical device access to the Korean market, and maintain effective communications with national regulators and representatives of international manufacturers.
OUR SERVICES AT A GLANCE
- MFDS recognised - TÜV SÜD Korea is approved by the MFDS as a third party body to conduct technical file reviews for all Class II product categories. CB test reports for electrical/electronic medical devices issued by TÜV SÜD are also accepted by MFDS.
- Product safety testing and certification - TÜV SÜD is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conducts thousands of in-depth risk management audits each year.
- Other testing and certification services - In addition to biocompatibility assessments required for medical devices, TÜV SÜD can also provide compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).