ABSTRACT
Until 1995, the Korean Ministry of Health and Welfare (MOHW) managed the requirements for evaluation and testing of medical devices prior to entry into the market under the pharmaceutical law. In 1993, Dr. Hwal SUH, a researcher in medical materials, petitioned the National Assembly of Korea to establish a new Special Regulatory System for Testing and Evaluation for Implantable Devices. According to Dr. SUH, a new regulatory system was needed because the pharmaceutical law was not suitable to regulate the currently developed biochemical and physiologically functioning implantable devices. In 1994, the MOHW launched a special committee to prepare regulations for medical devices separate from the pharmaceutical law. These regulations were modeled on the system in the United States and emphasize local testing of products. After approval at the National Assembly, the first medical device regulations became effective on January 1, 1995. The regulations are intended to screen new products for safety and efficacy before they are allowed on the Korean market. The increased regulation of medical devices was prompted by recent concerns about certain medical devices combined with increased consumer pressure.
