MDA Malaysia Releases Information on Harmonised Classification of Medical Devices in ASEAN

The Malaysian Medical Device Authority (MDA) has released the first edition of the guidance document on harmonised classification of regulations …

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Australia TGA Releases Guidance on Exemption for Certain Clinical Decision Support Software

The Therapeutic Goods Administration (TGA) Australia has released the first version of the guidance document on Exempt Clinical Decision Support …

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Australia TGA Updates Regulation of Software Based Medical Device

The Therapeutic Goods Administration (TGA) Australia has released updates on the regulation of software based medical devices in August 2022. …

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Australia TGA Releases Guidance on Exemption for Clinical Decision Support Software

The Therapeutic Goods Administration (TGA) Australia has released a guidance document on Exempt Clinical Decision Support Software (CDSS) for sponsors, …

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Singapore HSA Releases Information on Import and Supply of Unregistered Medical Devices

The Health Sciences Authority (HSA) Singapore has provided some guidance on the import and supply of unregistered medical devices by …

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MDA Malaysia Publishes Guideline on Re-registration of Registered Medical Device

The Malaysian Medical Device Authority (MDA) has released the first edition of the guideline on the re-registration process for registered …

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Australia TGA Publishes Latest Clinical Evidence Guidelines for Medical Devices

The Therapeutic Goods Administration (TGA) Australia has released the latest guidelines on clinical evidence requirements for medical devices, including in …

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Thailand FDA and Singapore HSA Collaborate on Expedited Medical Device Registration Program

The Food and Drug Administration (FDA) of Thailand and Health Sciences Authority (HSA) Singapore have formed an expedited program to …

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MDA Malaysia Releases Latest Guidance on Classification for General Medical Devices

The Malaysian Medical Device Authority (MDA) has released the second edition of the guidance document on the rules of classification …

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