REGULATORY LANDSCAPE FOR MEDICAL DEVICES
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 neighbors, 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.
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
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 authorized 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 recognized- 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 recognized 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).
Your benefits at a glance
- Recognized medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognized by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.
- Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.