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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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QT ACTIVITY: Post-Brexit medical device regulatory landscape

QT ACTIVITY: Post-Brexit medical device regulatory landscape

  • 2021-06-04 09:34:53

In this webinar, you will learn more about Brexit and how Geopolitics affects medical device regulations. Our expert will introduce you to UKCA. Moreover, Ms. Fatehi will discuss the transitioning out period and will outline how the future for the U.K. market will look like.

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 AUSTRALIA: Regulatory changes for software based medical devices – May, 2021

AUSTRALIA: Regulatory changes for software based medical devices – May, 2021

  • 2021-05-22 03:59:29

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.

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AUSTRALIA: Regulatory changes for software-based medical device

AUSTRALIA: Regulatory changes for software-based medical device

  • 2021-03-22 01:22:59

The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

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 NOTICE: Apology for delay in China regulatory business

NOTICE: Apology for delay in China regulatory business

  • 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed

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