Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
Singapore HSA’s GL-04 Revision 4 updates regulatory guidance for Software as a Medical Device (SaMD) and Machine Learning-enabled Medical Devices (MLMD). Key changes include expanded scope for ML functions, lifecycle governance, enhanced cybersecurity requirements, structured change management via CMP, and alignment with IMDRF/ISO standards. Manufacturers must strengthen lifecycle oversight, post-market monitoring, and ML model documentation to comply with the updated framework.
From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments.
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