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”,
Regulatory News
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
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 of Understanding (MOU) for cooperation in healthcare regulatory matters pertaining
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’ regulatory requirements and processes, HSA announced some regulatory changes made
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 of Clinical Decision Support Software (CDSS).
Key Updates are as following:
• Change