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TAIWAN: TFDA NOTICE: AMENDMENT ON “REGULATIONS GOVERNING THE CLASSIFICATION OF MEDICAL DEVICES”– OCTOBER/NOVEMBER 2023

TAIWAN: TFDA NOTICE: AMENDMENT ON “REGULATIONS GOVERNING THE CLASSIFICATION OF MEDICAL DEVICES”– OCTOBER/NOVEMBER 2023

  • 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

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TAIWAN: TFDA Announcement: Cease to comply with the regulation regarding "Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR"  – November, 2020

TAIWAN: TFDA Announcement: Cease to comply with the regulation regarding "Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR" – November, 2020

  • 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

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