As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in Singapore’s regulatory requirements and processes, the Vigilance and Compliance Branch, Health Products Regulation Group, has updated
Regulatory News
Malaysia NPRA Updates Drug Registration Guidance Document (DRGD) Regarding Variation Application of Registered Products: Processing Time Period for All Product Categories and Introduction of Reliance Mechanism for Pharmaceutical Products
Malaysia NPRA has release circular on Drug Registration Guidance Document (DRGD) guideline Updates on Variation application processing timeline for all registered products including all product categories and Introduce Reliance Mechanism
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group, has updated
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 revised definitions have been added for “Machine Learning”, “AIMD”, “Cybersecurity”,
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 of Verification.
As part of the revision, the MDA has expanded
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 strategies recently implemented.
TGA’s graphs confirm that the backlog for GMP
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 Ingredients in Health Supplements and Traditional Medicines.
The guidelines provide essential information
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 product registration and licences submission which replaced the previous online
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 Identification (UDI) regulatory framework that came into effect on 24