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New Guidance on Usability Requirements for Medical Device Manufacturers [Reference for Press Release, Apr. 7, 2021]
  • Registration Date 2021-04-07
  • Hit 217

[Reference for Press Release, 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

Attached File
  • (4.7) New Guidance on Usability Requirements for Medical Device Manufacturers.pdf Download preview

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