Singapore HSA Publishes New Regulatory Guidelines for Laboratory Developed Tests (LDTs)

Laboratory Developed Tests (LDTs) are in vitro diagnostic tests (IVDs) that are: • developed and manufactured within a licensed clinical …

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Singapore HSA to Commence Phase 1 Implementation of Unique Device Identification (UDI) System

From 1st November 2022, all medical devices under the closed list of high-risk implantable published in HSA’s guidance document GN-36: …

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Singapore HSA Updates Guidance on Therapeutic Product Registration

The Health Sciences Authority (HSA) Singapore has published the updated guidance document on the regulatory processes and requirements for therapeutic …

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Singapore HSA Updates Guidelines on Voluntary Electronic Labelling for Complementary Health Products

The Health Sciences Authority (HSA) Singapore has published the updated guidance document on voluntary electronic labelling for complementary health products …

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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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Singapore HSA Releases Guidelines on Claims and Claims Substantiation of Health Supplements and Traditional Medicines

The Health Sciences Authority (HSA) Singapore has released guidelines on claims and claims substantiation for Health Supplements (HS) and Traditional …

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Singapore HSA Releases Guideline on Voluntary Notification System for Health Supplements and Traditional Medicines

The Health Sciences Authority (HSA) Singapore has released a new guideline to outline the process involved for voluntary notification of …

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Singapore HSA Publishes Guideline on Testing Requirements of Health Supplements and Traditional Medicines

The Health Sciences Authority (HSA) Singapore has published the latest version of the guideline on testing requirements for health supplements …

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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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