In April 2012, the Korean FDA (KFDA) made significant changes in its Medical Device Act, which stipulates regulations for medical devices. The revised Medical Device Act improves transparency and predictability for medical device approval. Within the Medical Device Act, the KFDA released detailed information for Class II to IV medical devices.
Among the new Korean regulations are:
- The pre-market approval process for medical devices has been reorganized according to the level of risk presented by the medical device. Lower risk devices now have a shorter registration process with fewer requirements. Review of Class II medical devices have been outsourced to third party organizations as many of them are well known devices or are “me too” products.
- For Class III and IV devices, technical review of the medical device is mandatory. For the technical review, devices with Substantial Equivalency (SE) to a previously approved predicate device and devices without Substantial Equivalency (non-SE) have a key difference in clinical report requirement. For SE devices, medical device companies can submit clinical reports for that previously approved device and do not need to submit clinical reports for their own specific device. For non-SE devices, medical device companies must submit clinical reports for their own device. If the KFDA determines that foreign clinical reports are sufficient, then no local clinical studies in Korea are necessary.
- A new KGMP Certification system for foreign manufacturers was introduced. For products already approved, the KFDA will grant importer KGMP certificates for the remaining period of the importer’s KGIP certification. For new products or new manufacturing sites of existing manufacturers, KGMP certification will be required either through an on-site inspection or document review.
- The KFDA will be more open to accepting foreign test reports and manufacturer data conducted under international standards, such as ISO 10993, ASTM, USP standards, etc. by a GLP lab.
- The KFDA will begin regulating in-vitro diagnostics (IVD) as medical devices beginning January 1, 2013.