The Revision 7 introduces several structural and procedural updates to streamline medical device regulatory submissions. The most significant change is the platform migration from MEDICS to SHARE, marking a complete transition across all application processes.
Scope
Summary of the updated GN-02 Guidance Document (Revision 7) issued by the Health Sciences Authority (HSA), Singapore, outlining the transition to the SHARE platform, updated QMS requirements, and clarified responsibilities for medical device dealers.
Key Highlights
Platform Migration to SHARE
The most significant change is the platform migration from MEDICS to SHARE, marking a complete transition across all application processes.
Class A Device Listings – Product Notification
Class A device listings now fall under “Product Notification” in SHARE.
Device dealers must submit an “Amendment” under “Product Notification” in SHARE prior to importation and supply.
Quality Management System (QMS) Requirements
QMS requirements are clarified — importers and wholesalers may use either SS 620 (GDPMDS) or ISO 13485 certification for distribution scope compliance.
Dealer’s Licence Renewal
Dealers who are not on the auto-renewal scheme are required to submit their renewal application via SHARE at least 14 calendar days before expiry. An auto-reminder email will be sent 60/45/30 days prior to the licence expiry date.
Applicant’s Responsibilities
Applicant’s responsibilities are clearly defined in this version to support accountability and compliance.
For more information, read the guidance document: [LINK]
Implications to Clients / Stakeholders
The migration to the SHARE system mandates full adaptation to a new submission workflow for all licensing, notification, and renewal activities. Stakeholders must ensure regulatory readiness, including valid QMS certifications (SS 620 or ISO 13485) and accurate documentation aligned with new submission templates. The revised timelines and reminder emails aid strong internal coordination for dealer’s licence renewal.
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