Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can …
Singapore HSA Updates Guidance on Unregistered Therapeutic Product Import and Supply
In March 2023, HSA updated Guidance on Import and Supply of An Unregistered Therapeutic Product For Patients’ Use. See Pharma …
Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023. This guidance …
Singapore HSA Updates Unregistered Therapeutic Product Import and Supply Guidance and Forms
Singapore HSA Updates Guidance TPB-GN-004-005 regarding the Import and Supply of an Unregistered Therapeutic Product For Patients’ Use. HSA includes …
Singapore HSA Enhances Medical Device Change Notification Process
Singapore HSA has enhanced the Change Notification application process for Medical Device online platform (MEDICS) that will come into effect …
Singapore HSA Updates Guideline on Voluntary Notification System for Health Supplements and Traditional Medicines
HSA recently reviewed the newly implemented notification process, and HSA updated the Guideline on Voluntary Notification System for Health Supplements …
Malaysia MDA Implement Guideline On How To Submit An Application For Registration Of A Refurbished Medical Device
Malaysia MDA implement first edition guideline on “How To Submit An Application For Registration Of A Refurbished Medical Device (MDA/GL/10), …
Singapore HSA Shares Statistic on HSA’s Mean Screening Time and Applicant’s Mean Screening Response Time For New Application and Major variation Applications
HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the …
Singapore Ministry of Health (MOH) Extends Special Access Routes (SAR) Review Timeline and Updates MOH Clinical Justifications Form for Class D SAR Application
Singapore MOH has updated the “MOH Clinical Justifications Form for Class D SAR Application” for the GN-26 and GN-27 SAR …