Singapore HSA Publishes Latest Guidance on Special Access Routes

The Health Sciences Authority (HSA) Singapore has published the latest guidance document on special access routes (SAR), that provide a …

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Australia TGA Publishes Information on Manufacture of Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published some information regarding the manufacture of medical devices pertaining to quality management …

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Australia TGA Publishes Latest Guidance on Reclassification of Active Implantable Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published the latest document on the reclassification of active implantable medical devices (AIMD) …

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MDA Malaysia Publishes Guidance Document on Refurbished Medical Devices

The Malaysian Medical Device Authority (MDA) has published a guidance document on the requirements for refurbished medical devices in January …

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Singapore HSA Publishes Revised Guidance on Grouping of Medical Devices for Product Registration

The Health Sciences Authority (HSA) Singapore has published the latest guidance document on the grouping of medical devices for product …

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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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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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