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 …
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 …
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 …
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 …
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 …