New Guidance on Usability Requirements for Medical Device Manufacturers [Press Release for Reference, April 7, 2021]
- Registration Date 2021-04-07
- Hit 12942
[Press Release for Reference, April 7, 2021 / Unofficial Translation]
□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has established and published two sets of “Usability Guidelines for Medical Devices” to raise awareness of medical device usability requirements, which will be gradually implemented based on device classification*.
* Full implementation dates: Class 4 medical devices from Jan 1, 2021; Class 3 from July 1, 2021; Class 2 from Jan 1, 2022
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