Singapore’s Health Sciences Authority (HSA) recently conducted a Medical Devices Industry Briefing to introduce the transition from the existing MEDICS system to the new SHARE platform, Singapore Health Product Access and Regulatory E-System. The shift marks a major leap forward in digitalizing regulatory processes across the product lifecycle.
Here’s what medical device companies need to know as the new system rolls out in July 2025.
Why SHARE Matters
SHARE is designed as a unified platform that brings together regulators, businesses, and industry partners into one integrated ecosystem. It aims to:
- Streamline regulatory submissions.
- Enhance visibility into application statuses.
- Support faster, safer access to health products in Singapore.
Key Differences Between MEDICS and SHARE
The table below summarizes critical changes affecting how companies will manage their regulatory tasks under SHARE:
|
Feature
|
In MEDICS
|
In SHARE
|
|
Class A
Product Notification
|
Submitted as an Excel sheet in Dealer Licence application; Free Sale Certificate application via FormSG
|
Standalone
Product Notification application; Free Sale Certificate application via SHARE
|
|
Third
Party Access
|
Requires
separate HSA PIN request
|
Direct
request for access within SHARE
|
|
Importer
Assignment by Registrant
|
No
acknowledgement needed by Importer; must assign Importer and Wholesaler
|
Importer to
accept tagging assignment; no need to assign Wholesaler
|
|
Export
Certificate
|
Needs prior
Notification for Export
|
Direct
application submission
|
|
Fulfilment
of Approval Conditions (FoAC)
|
Offline email
submission with no reminders
|
Online
tracking and submission with automated reminders
|
|
Auto-Retention for GIRO Users
|
Triggered 1
day after due date
|
Triggered 30
days before due date
|
|
Cancellation
|
Effective
immediately upon approval
|
Applicant can
set a future effective date
|
|
Online
Payment for New Registration
|
Full payment
up front upon submission
|
Payment
split: application fee upon submission, evaluation fee upon route
confirmation
|
|
Companies
with GIRO Arrangement
|
GIRO is
default payment mode
|
Can choose
payment mode during submission
|
Transition Timeline: From MEDICS to SHARE
|
Date
|
Milestone
|
Action
Required
|
|
21 May
2025
|
Industry
briefing held
|
–
|
|
27 June
2025
|
Last day for
new submissions on MEDICS
|
Complete
urgent submissions by this date
|
|
4 July
2025
|
Last day for
IR responses on MEDICS (5:00 PM cutoff)
|
Respond to
urgent IRs by this date
|
|
4-13 July
2025
|
Cut-over
period (MEDICS offline)
|
MEDICS access
not available
|
|
14 July
2025
|
SHARE goes
live
|
Submit new
applications and pending IRs in SHARE
|
What You Should Do Now
To prepare for the system switchover, HSA advises companies to:
- Submit urgent applications on MEDICS before 27 June 2025.
- Respond to urgent IRs on MEDICS before 4 July 2025.
- Set up user access to SHARE in CorpPass before 14 July 2025.
For more information, you may refer to the presentation slides and FAQ below:
Official Source: SHARE for Medical Devices Industry Briefing Session
Published by HSA on 30 May 2025
