When registering a medical device in Korea, an applicant must demonstrate Korean GMP (KGMP) compliance. Previously, under the Pharmaceutical Affairs Act, foreign manufacturers could demonstrate KGMP compliance with an ISO 1348:2003 or US FDA QSR certification. Also, KFDA audits only applied to Korean manufacturers. The Pharmaceutical Affairs Act covered both medical devices and drugs.
However, to better cover medical devices and speed harmonization, the new Medical Device Act was passed in 2003 and went into implementation in 2004. Full enforcement, including new regulations on KGMP compliance, will go into effect from May 29, 2007.
The new rules for KGMP compliance under the Medical Device Act now state that importers of medical devices will be subject to either local testing or filing essential test reports now required by the KFDA. Foreign manufacturers without a Korean office must apply either through an importer or an independent third party (to have the registrations in the manufacturer’s name). Therefore, though importers could previously demonstrate the foreign manufacturer’s KGMP compliance with an ISO 13485:2003 or US FDA QSR certification, specific testing or testing reports are now required. This new regulation is under the Medical Device Act and is part of the Import and Quality Management Systems (locally called Good Import Practices, or GIP).
KFDA currently has a list of essential tests required for imported medical devices. These tests are to ensure the quality of imported products and range from sterility tests to grounding resistance tests depending on the product. Importers will need to determine if foreign manufacturers already have required test reports or if local testing is necessary.