The Health Sciences Authority (HSA) is transitioning its Medical Device product registration and license submissions from the current MEDICS platform to a new system called SHARE (Singapore Health Product Access and Regulatory E-System). To introduce this change, HSA Singapore held an industry briefing on May 21, 2025, outlining the features of the new SHARE platform. The full shift to SHARE will take place on July 14, 2025.

This new streamlined portal reflects HSA's ongoing commitment to simplify regulatory processes, making it easier and more efficient for businesses to comply with essential regulations.

Key Milestones and Transition Timeline

HSA Singapore advises all stakeholders to note the following timeline to ensure a smooth transition.

Period	Activity	Comments
21 May 2025	SHARE for Medical Device Industry Briefing
27 June 2025	Stop accepting NEW application submissions via MEDICS	IR responses still accepted for ongoing applications. All urgent applications should be submitted through MEDICS before this date.
4 July 2025	Stop any changes to applications in MEDICS, including IR responses by 5:00 PM	Any changes made to applications on MEDICS after this will NOT be migrated to SHARE. All urgent Input Requests on MEDICS should be responded by this date.
4 – 13 July 2025	Cut-over period	MEDICS will be completely taken down. No further access to MEDICS will be available after start of cut-over. This period is to ensure smooth transition and data migration from MEDICS to SHARE.
14 July 2025	General Availability Go Live of SHARE	Companies can submit NEW applications in SHARE For ongoing applications, pending IRs from MEDICS will be re-sent in SHARE. Before 14 July, stakeholders may grant user access to SHARE in CorpPass

Key System Enhancements – SHARE vs. MEDICS

To provide enhanced access for Medical Device registration and licensing, SHARE incorporates several changes and updates, as outlined below:

Items	In MEDICS	In SHARE
Class A Product Notification	The application was submitted as part of Dealer License application or Amendment as a single excel sheet. *such approach often resulting 'dirty' data and error by the system	Submitted independently as a "Product Notification" application. Allow amendment of existing notified Class A products Alternative ways to key in product information
Free Sale Certificate application for Class A	Through FormSG	Through SHARE
Third Party Entity Access	Applicant need to separately request for HSA Pin on behalf of the 3rd party company	Applicant can directly request 3rd party access for the query raised through SHARE (no need for HSA Pin)
Importer assignment by Registrant	Registrant will add authorized importer and wholesaler to a device listing via "Assignment of importer wholesaler ship and management of view access to importer wholesaler".	Importer (under a different UEN) to accept the tagging assignment by Registrant. No need to assign authorized Wholesaler for the device listing.
Export Certificate	Submit "Notification for Export" before submitting Export Certificate application.	Export Certificate application submitted directly (no need for "Notification for Export")
Fulfilment of Approval Conditions (FoAC)	No reminders Offline submission via email from applicant to HSA	Company users will be able to track their approval conditions and submit FoAC applications directly. Closer to due date, system will send reminders to applicant on the pending task.
Auto-Retention of Product listings for companies with GIRO arrangement	Auto-retention for registered products are triggered 1 day after device retention due date. *different timeline for Product listing auto-retention and Dealer's License auto-renewal date.	Auto-retention for registered products to be triggered 30 days before device retention due date. *both Product listing auto-retention and Dealer's License auto-renewal date will be triggered T-30 days.
Cancellation	Cancellation effective immediately upon approval	Applicants can define a future effective cancellation date
Online Payment (for New Product Registration)	For companies with existing GIRO arrangement with HSA, payment mode is defaulted to GIRO; no online payment option	Companies can choose their preferred payment mode at point of submission

 

During the Industry Briefing Session, HSA also showcased SHARE's interface and features. These included the process for setting up access and company information, submitting new applications, managing dossier requirements and uploads, updating company contacts, applicant information, and notification emails, handling input requests, and checking the status of draft, active, and closed applications. A detailed Quick Start to SHARE is readily available on HSA official page.

Additionally, HSA compiled a Frequently Asked Questions (FAQ) document based on queries from participants. This document addresses topics such as SHARE System Access and User Management, File Management and System Capabilities, Application Management, System Features and Limitations, Data Migration and Transition, and Medical Devices Specific Queries, etc. The FAQ document is also publicly available on HSA official page.

Call-to-Action

Qualtech Consulting Corporation brings over 25 years of experience as a trusted partner to medical device manufacturers. We've successfully guided clients through countless dynamic regulatory and authority platform shifts across diverse international landscapes. 

Whether you're a local startup or an international player, we empower your devices to enhance lives. 
Connect with us today here to unlock your medical device potential.

 

References

1. SHARE for Medical Devices Industry Briefing Session
2. Introducing "SHARE" - Your digital portal for Medical Devices
3. SHARE for Medical Devices - Industry Briefing Session
4. Frequently Asked Questions (FAQ) for: Singapore Health Product Access and Regulation E‐System (SHARE) – Post-Industry Briefing