MFDS Announces Partial Amendment to the Medical Devices Act Enforcement Rule
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| Medical Devices (MFDS) |
The Ministry of Food and Drug Safety (MFDS) has announced a partial amendment to the Enforcement Rule of the Medical Devices Act.
Public opinions will be collected until July 23, 2024.
• The basis for the disclosure of comprehensive plans and implementation plans for medical device safety management will be established.
• The reporting procedure will be clarified to allow the manufacturing and import of low-risk Class I medical devices through manufacturing and import notification only.
• To clarify the medical device notification acceptance procedure, the acceptance period will be set to 5 days, matching the Class II certification period, and a new form for the notification acceptance certificate (including conditional certificates) will be established.
• Clinical trials with minimal risk to participants will be exempt from clinical trial plan approval.
• Clinical trials that non-clinical trial institutions can participate in will be defined, and guidelines for submission materials for clinical trial plan approval applications, as well as standards for the management and supervision of these institutions, will be established.
• Detailed provisions will be established for the concurrent display of Braille and codes for voice and sign language video conversion to ensure that visually and hearing impaired individuals can use medical devices correctly.
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