All medical devices sold in Korea must obtain approval from the Korea Food & Drug Administration (KFDA) before they may be sold and marketed in that country. The Medical Devices & Radiation Health Department of KFDA is charged with the inspection and quality assurance of medical devices, among other things.
Regulations for the approval of medical devices are relatively new (KFDA has directly regulated medical devices for only about four years). As a result, regulations tend to be vague and somewhat confusing. The government is acting to rectify this and hopes to sign into law new, product-specific regulations by the end of the year. In the meantime, medical device manufacturers may turn to their Korean distributors for help with regard to product-specific requirements.
Despite the ambiguity with respect to specific devices, general regulations and requirements are as follows. First, in order to be considered for registration in Korea, a medical device must be approved for sale in its country of manufacture. Required documentation for the registration of Class II and III devices includes: a USFDA Certificate to Foreign Government; GMP certificate; copy of the FDA Annual Registration Certificate; a description of the quality system used by the manufacturer; any relevant certifications to international technical standards (including ISO certifications, etc.); and reports from clinical trials. Local type testing is also generally required.
Receiving KFDA approval generally takes 1-3 months for Class I devices and 6-8 months for Class II and III devices. The approval period is measured from the time of documentation submission. Therefore, the time a manufacturer spends preparing the documentation is not figured into these figures. Additionally, if there is a problem with any of the documentation, approval periods may also be elongated.