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Software Review as the Only Requirement for Approval of AR/VR-Based Medical Devices [Press Release, April 30, 2021]
  • Registration Date 2021-05-03
  • Hit 125

[Press Release April 30, 2021 / Unofficial Translation]


On April 30, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) released the revision of The Guidelines on Review and Approval of AR/VR-Based Medical Devices which is aimed at improving safety review method and clarifying products subject to clinical test requirement.

Attached File
  • (4.30) MFDS Revises Guidelines on Review and Approval of ARVR-Based Medical Devices.pdf Download preview

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