From November 17, 2023, it has been partially revised to clarify administrative procedures by preparing standards and procedures for lifting the designation of medical devices subject to follow-up management and to match the name of the medical device subject to follow-up management with the item name specified in the Regulations on Medical Device Items and Classes by Item.
The major revisions are as follows.
A. Preparation of standards and procedures for lifting the designation of medical devices subject to follow-up management (Articles 2 and 2-2)
Establish specific review criteria for designation and release of medical devices subject to follow-up management (like the possibility of side effects or defects, severity of harm, etc.) and periodic review procedures (regularly reviewed every three years, deliberated by the Medical Device Committee).
B. Revision of the item name of the medical device subject to follow-up management (Article 2-3 of the draft)
It is intended to prevent confusion in the business of civil petitioners by matching the item name of the previously designated medical device subject to follow-up management with the item name prescribed in the Regulations on Medical Device Items and Classes by Item.
Please refer to the file below for details.
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