Singapore HSA Announces eCTD Format Officially Accepted for Therapeutic Products Regulatory Dossier Submission
Singapore HSA announces that electronic Common Technical Document (eCTD) format will be officially accepted for Therapeutic Products regulatory dossier submission …
Singapore HSA Updates Guidance on CTGTP Registration and Variation Applications
Health Sciences Authority (HSA) has updated the Guidance on Cell, Tissue or Gene Therapy Product (CTGTP) Registration and Variation Applications …
Singapore HSA and Malaysia MDA Jointly Launches Medical Device Regulatory Reliance Programme
The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding …
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 …
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