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AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

  • 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

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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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