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
Regulatory News
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
Singapore HSA Revises FSCA Related Guidances for Medical Device GN-09 and GN-10
Singapore Health Sciences Authority (HSA) revises guidance documents related to Medical Device Field Safety Corrective Action (FSCA).
Detail of the updates are indicated in the newly released Guidance documents listed below:-
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Singapore HSA Updates Medical Device Guidance on Change Notification
Singapore HSA has updated GN-21: Guidance on Change Notification for Registered Medical Devices, effective 14th July 2025.
Key Updates to GN-21 include:
– Expanded the list of changes which do not require
Malaysia NPRA Publishes Screening Package for New Drug Products and Biologics
To enhance the submission process, Malaysia NPRA has developed a screening package for New Drug Products and Biologics to provide clearer guidance and promote Good Submission Practice.
This tool is designed
Vietnam Ministry of Health Issues Circular on Registration of Drugs and Medicinal Ingredients for Circulation in Vietnam
On May 16, 2025, Vietnam Ministry of Health issued the Circular No. 12/2025/TT-BYT which will take effect from July 1, 2025. This is a crucial legal document detailing the registration
Malaysia Medical Device Authority (MDA) announces two key changes to the Product Classification Letter process.
1. Fully Online Application Process
In line with its digital transformation efforts, MDA will fully transition to online submissions for product classification applications via Google Forms, effective 1 May 2025.
• All
FDA Philippines Issues Advisory on Streamlined Submission of Multiple Post-Approval Changes (PACs)
The Food and Drug Administration (FDA) Philippines released FDA Advisory No. 2025-0496 on 10 April 2025, titled “Allowing the Submission of Multiple Post-Approval Changes (PACs) of a Registered Pharmaceutical Product