Key Highlights
Revision 4 reminded applicants that the online submission platform has transited from MEDICS to SHARE.
The inclusion of a dedicated Machine Learning documentation section establishes robust expectations for ML-enabled devices, covering model design, training validation protocols, and risk management and others per GL-04 guidelines.
Additionally, the new ISO 13485 certification rule mandates accreditation by IAF-recognized or EU MDR/IVDR-Notified Bodies, tightening quality controls. Collectively, these revisions elevate Singapore’s regulatory framework to align with global best practices while reinforcing patient safety and technological accountability.
Read the full guidance document here:
GN-17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT: [LINK]
GN-18: Guidance on Preparation of a Product Registration Submission for InVitro Diagnostic Medical Devices using the ASEAN CSDT: [LINK]
Implications to Clients / Stakeholders
All stakeholders must adapt to the SHARE platform and comply with stricter documentation and certification standards. Manufacturers need to ensure ISO 13485 certificates meet new accreditation criteria, while software (including machine-learning enabled ones) must align documentation with GL-04 requirements. Collectively, these measures enhance medical device safety and efficacy throughout its lifecycle.
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