South Korea MFDS Regulatory Approval Process for Medical Devices
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Medical device and IVD manufacturers that want to sell their products in South Korea will have to follow the requirements of the Medical Devices Act, a set of regulations put forth by the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration). For more information on getting approval for the South Korean Market, download the chart.
Related services for South Korea:
- Korea Good Manufacturing Practice (KGMP) for medical device manufacturers
- South Korea License Holder for MFDS (KFDA)
- Medical Device Classification in South Korea