In-Vitro Diagnostic Guidelines in Korea

New IVD regulations are being developed throughout Asia. In Korea, before IVDs are permitted to enter the Korean medical market, these products require approval by the Korean Food and Drug Administration through a process similar to the pre-market approval (PMA) process for medical devices. IVDs that are used for research purposes only (not for patient use) are not required to undergo pre-market approval. For approval, the KFDA generally requires a safety and efficacy review, for which foreign IVD manufacturers must submit clinical reports investigating the use of their IVDs. If there are no clinical reports on the IVD, the manufacturer must then conduct local clinical studies in Korea.

Product approval for IVDs requires the submission of adossier file to the KFDA. Among the required documents are the original Certificate to Foreign Government issued by the U.S. FDA and the notarized Certificate of Manufacture. The foreign IVD manufacturer must also submit descriptions of the manufacturing process, performance and stability tests, clinical test reports, and quality control records. In addition, other required items are the user’s manual, other product literature, and finished product samples. The approval process is very lengthy; it generally can take from 1 to 1.5 years to get product approval. However, recent discussions with the KFDA have revealed that it is beginning to discuss ways of streamlining and shortening the product approval timeline. Companies looking to get their IVDs approved in Korea should push for a streamlining process.