ARQonDec 10, 20182 minSingapore HSA drafts user-friendly ASEAN CSDT Guidance and e-Submission Guide, complements ARQon talSingapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for...
ARQonNov 5, 20181 minAsia, Africa & Middle East - Dec 2018AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...
ARQonAug 30, 20181 minSingapore incorporated IMDRF Essential Requirements including CybersecuritySingapore: HSA preparing manufacturer for the new ER IMDRF elements and cybersecurity. The new version Essential Requirements (ER)...
ARQonAug 30, 20181 minHSA & ARQon active role in Medtech product development for local and global requirementsLocal Compliance HSA has recently set up an Innovation Office, a regulatory advisor for product development, in pursuit of greater...