MFDS to Revise Regulations for Rapid Introduction of Medical Devices in Case of National Crisis

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Regulations for the Enforcement of the Medical Devices Act
Regulations for the Enforcement of the Medical Devices Act (Freepik)

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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