Singapore: SHARE digital portal launched for medical devices

30 Jun 2025    2 minute read
Sectors Healthcare & Life Sciences

In brief

On 21 May 2025, the Health Sciences Authority (HSA) conducted an industry briefing to provide updates on the implementation of the Singapore Health Product Access and Regulatory e-System (SHARE) for medical devices. The session highlighted key changes implemented for medical devices on SHARE, the user interface, and key features available on SHARE. SHARE will be launched from 14 July 2025.

Contents

In more detail

SHARE is a digital platform developed by the HSA to streamline regulatory submissions. It will replace the existing Medical Device Information Communication System (MEDICS) and provide a unified and integrated platform for regulators, businesses, industry partners, and the general public to collaborate and manage product lifecycle activities more efficiently. Our previous client alert on SHARE may be found here.

In an industry briefing on 21 May 2025, the HSA outlined several key changes to SHARE aimed at streamlining regulatory processes and improving user experience:

1. Independent product notifications: Class A product notifications can now be submitted independently in SHARE, as opposed to being bundled within dealer license applications or amendments via a single Excel sheet in MEDICS.

2. Third party access: Applicants can now directly request third party access for queries raised through SHARE, eliminating the need for separate HSA pin authorization requests.

3. Importer assignment: Importers under a different UEN must now acknowledge and accept tagging assignments by registrant directly, with no requirement to assign authorized wholesalers for the device listing.

4. Export certificates: Applications can be submitted directly in SHARE without prior export notifications.

5. Fulfilment of Approval conditions (FoAC): Company users can track their approval conditions and submit FoAC applications directly through SHARE, with new automated reminders sent as the due date approaches.

6. Auto-retention: For companies with GIRO arrangements, auto-retention of product listings will now be triggered 30 days before the due date, compared to one day after in MEDICS.

7. Future-dated cancellations: Applicants can now define future effective dates for cancellations, compared to immediate cancellation upon approval in MEDICS.

8. Flexible payment options: Online payments for new product registrations will now be triggered at these timepoints: application fee upon submission and evaluation fee upon confirmation of the evaluation route. This aligns with triggers for payment via GIRO. Companies with GIRO arrangements can now choose their preferred payment mode at the point of submission.

From 14 July 2025, companies may access SHARE with their CorpPass.

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Contact Information
Andy Leck
Principal
Singapore
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andy.leck@bakermckenzie.com
Ren Jun Lim
Principal
Singapore
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ren.jun.lim@bakermckenzie.com

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