Hong Kong Drug Office Updates Frequently Asked Questions’ Page

Hong Kong Drug Office has provided the latest set of frequently asked questions (FAQs) on their official website at the …

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Singapore HSA Publishes Updated Guidelines on Software Medical Devices

The Health Sciences Authority (HSA) Singapore has published an updated version of the guidelines for software medical devices (MD) in …

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Philippines FDA Updates Circular on Transition Period for Certificate of Medical Device Notification

The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-002-B, an amended version of Circular No. 2021-002-A. …

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Singapore HSA Publishes Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software

The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the determination of risk classification …

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MDA Malaysia Issues First-Edition Document on Classification of Devices

The Malaysian Medical Device Authority (MDA) has published the first edition of a guidance document on the classification of products …

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Medsafe New Zealand Publishes Updates on Regulation of Therapeutic Products

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued the second version of the guideline on the …

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Singapore HSA Publishes Regulatory Updates for Therapeutic Product Registration

The Health Sciences Authority (HSA) Singapore has provided a list of the latest regulatory updates for therapeutic product registration in …

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Singapore HSA Publishes Guidelines on Safety of Ingredients for Traditional Medicines and Health Supplements

The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the establishment of ingredients’ safety …

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Australia TGA Publishes Latest Guidance on Medical Device Patient Information Leaflets and Implant Cards

The Therapeutic Goods Administration (TGA) Australia has published the latest version of the guidance document on patient information materials (patient …

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