Singapore HSA Updates Guidelines on Software Medical Devices (GL-04)
The revised guideline includes several key changes: Document title has been updated to include machine learning-enabled medical devices. New and …
Malaysia MDA Updates Policy on Conformity Assessment Procedures for Medical Device approved by recognised countries
Malaysia MDA has released an updated version of its Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way …
Australia TGA updates GMP clearance Sponsor Information Dashboard (SID)
The TGA have updated their GMP clearance Sponsor Information Dashboard (SID) to provide an update on the GMP backlog reduction …
Singapore HSA Publishes New Guidelines on Prohibited and Restricted Ingredients in Health Supplements and Traditional Medicines
The Health Sciences Authority (HSA) is pleased to inform of the publication of new Guidelines on Prohibited and Restricted …
Singapore HSA Updates Multiple Medical Device Guidances
In July 2025, HSA launched the new online platform SHARE (Singapore Health Product Access and Regulatory E-System) for Medical Devices …
Australia TGA presents the UDI Launch Workshop (Sydney)
Are you a Sponsor or Manufacturer of a medical device on the ARTG? Are you aware of the Unique Device …
Singapore HSA Signs Memorandum Of Understanding With Hong Kong DoH To Enhance Healthcare Regulatory Cooperation
Singapore’s Health Sciences Authority (HSA) and the Department of Health (DoH), Hong Kong Special Administrative Region (HKSAR) signed a Memorandum …
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore’s Health Sciences Authority (HSA) ongoing initiative to improve regulatory efficiency and enhance clarity in Therapeutic Products’ …
Singapore HSA Updates Guidelines on Risk Classification of SaMD and Qualification of CDSS
Singapore HSA Medical Devices Cluster has updated Guidelines on Risk Classification of Software as a Medical Device (SaMD) and Qualification …
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