Korea Update: Medical Device Harmonization Efforts

The Korea Food and Drug Administration (KFDA) has continued its efforts on harmonization of medical device standards with the enactment of medical device Good Clinical Practice (GCP) regulations on July 14, 2005. Previously, GCP regulations were not established for medical devices in Korea, and these new regulations will help to demonstrate that GCP standards in Korea for clinical trial procedures and practices are in accordance with international standards. The new GCP rules, which the KFDA plans to strictly enforce, are similar to the existing ICH consistent GCP regulations for pharmaceuticals.

Since the new GCP regulations will require stricter guidelines and increased regulatory efforts, medical device companies will be confronted with higher costs. Clinical study costs will increase due to the need to employ, as well as to train, more individuals to engage in monitoring, managing, and reporting activities. As foreign medical device companies attempt to comply with the regulations, they may also face pitfalls such as delays in obtaining approval for devices.

Korea is a member economy of two harmonization efforts, the Asia Harmonization Working Party and the Asia Pacific Economic Cooperation (APEC) Network on Pharmaceutical Regulatory Science, which was held in Taipei from November 14–15, 2005. APEC is proactively striving to meet international standards for medical devices.

In the past, there were few attempts to encourage international harmonization of medical device regulations in Asia. As globalization has increased, there has been a greater need for regional organizations to provide discussions and encourage better understanding of the necessity for compliance with international standards.