Australia TGA Publishes Frequently Asked Questions on Software-Based Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on software-based medical devices in …

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Philippines FDA Publishes Update on Transfer or Refund of Payments 

The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-027, which is the revised guidelines for the …

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Hong Kong Drug Office Publishes Latest Guidance for Import and Export Licences

Hong Kong Drug Office has published an updated guidance document for the application of import and export licences for pharmaceutical …

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Australia TGA Updates Guidance on Regulation of Listed Disinfectants

The Therapeutic Goods Administration (TGA) Australia has published the updated guidance document on the regulation of listed disinfectants in December …

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Singapore HSA Publishes Revised Guidance on Medical Device Product Registration

The Health Sciences Authority (HSA) Singapore has published the latest guidance document on medical device product registration in January 2022.   …

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Australia TGA Releases Frequently Asked Questions on Reclassification of Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on reclassification of medical devices …

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Australia TGA Publishes Updates on Personalised Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published the latest document on personalised medical devices, including 3D-printed devices, in November …

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Australia TGA Publishes Guidance on Standards for Biologicals

he Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 109 to provide a …

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Singapore HSA Publishes Finalised Medical Devices Product Classification Guide

The Health Sciences Authority (HSA) Singapore published the latest Medical Devices Product Classification Guide in November 2021, to assist with …

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