Singapore HSA Therapeutic Products Branch has extended the application of electronic labelling (e-labelling) to Pharmacy-only (P) and General Sale List (GSL) medicines with effect from 30 June 2026.
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Regulatory News
Singapore HSA Releases Best Practices Guide for Medical Device Cybersecurity
Singapore’s HSA Medical Devices Cluster previously released a draft Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The public consultation commenced on 10 March 2025 and closed on
Singapore HSA Revises Voluntary Notification Process for Complementary Health Products
Singapore’s Health Sciences Authority (HSA) revised the Voluntary Notification System (VNS) for Complementary Health Products (CHP), replacing the previous HSA’s review process with a company self-declaration process, effective 15 July
Singapore HSA Announces Regulatory Updates for Medical Devices IVDs
Singapore HSA has announced below medical devices regulatory changes related to IVDs, effective 2 June 2026.
1. Change in risk classification of COVID-19 IVDs
During the pandemic, COVID-19 IVDs were classified as
Singapore HSA Updates Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP
Singapore HSA updated Guidance for Post-marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (CTGTP), effective 1 April 2026.
Apart from editorial changes made, the following areas
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 with effect from 1 April 2026. Companies may continue with
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 in Singapore, as well as the related Minor Variation (MIV)
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 (MoU) during the 14th ASEAN Medical Device Committee (AMDC) Meeting
Singapore HSA Updates Guidance on Product Defect Reporting and Recall Procedures for Therapeutic Products and CTGTP
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