South Korea MFDS Medical Device Regulations
On April 24, 2024, the Ministry of Food and Drug Safety (MFDS) announced a draft revision of the Enforcement Rules of the Medical Device Act to expedite the introduction of necessary medical devices in the event of a national emergency, such as the COVID-19 pandemic.
Provisions will be established to exempt medical devices deemed necessary for the temporary introduction to prevent and control infectious diseases from the approval, certification, or notification process.
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