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SINGAPORE:  HSA Announced Draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS) – August, 2021

SINGAPORE: HSA Announced Draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS) – August, 2021

  • 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

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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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