The main regulatory body in charge of overseeing medical devices in South Korea is the Korea Food & Drug Administration (KFDA) established in 1996. Through the Medical Devices & Radiation Health Department, the KFDA performs inspections and quality assurance as well as conducts research on medical devices. Since the KFDA’s establishment, however, the agency has maintained much of its medical device regulations to general terms. While there are some specific requirements outlined for product registration in Korea (documentation, technical review, and type tests among others), there is a lack of details required for approvals specific to products, this has led to much confusion among many foreign medical device manufacturers.
To address these above problems, the Korean National Assembly is expected to write a draft legislation called the “Medical Devices Act” to be introduced into legislation in late 2002 or early 2003. This legislation aims to better codify more specific regulatory procedures and requirements. The Act would be distinct from the current Pharmaceutical Affairs Law under which much of Korea’s medical devices regulations have developed. Some of the proposed changes of the Medical Devices Act include the following:
- Adjustment and clarification of the definitions of products subject to medical devices regulation
- Inclusion of medical software under KFDA regulation
- Addition of specific provisions regarding used or reprocessed and leased devices
- Transforming from a three tier classification scheme to a four tier scheme
- Implementing new post-market surveillance regulations