Singapore HSA Medical Device Registration vs Dealer Licence: SHARE Decision Guide

Quick answer

Singapore regulates medical devices under the Health Products Act and Health Products (Medical Devices) Regulations 2010. Companies must hold a dealer's licence before manufacturing, importing, or supplying medical devices. Most devices also require HSA product registration before supply — except Class A low-risk devices, which require product notification in SHARE instead of full registration. All submissions are made through SHARE (Singapore Health Product Access and Regulatory E-System) for medical devices.

Who this applies to

• Manufacturers placing devices on the Singapore market
• Importers bringing devices into Singapore
• Wholesalers supplying devices locally
• Registrants responsible for product registration or notification

Device scope: Class A, B, C, and D medical devices under HSA classification.

Dealer licence vs product registration: what is the difference?

You often need both a dealer licence and product registration/notification — they are not interchangeable.

SHARE portal: what you submit where

SHARE (Medical Device) supports:

• New Product Registration Application (Class B, C, D)
• Product Notification — new and amendments (Class A)
• Dealer licence applications and amendments
• Change of registrant
• Free Sale Certificate requests
• Singapore Medical Device Register (SMDR) and Class A Medical Device Database lookups

SHARE replaced MEDICS for new submissions from 14 July 2025 (ongoing MEDICS applications may transition per HSA announcements). Access requires Corppass.

Official resource: https://www.hsa.gov.sg/e-services/share-medical-device/

Class A — product notification (not registration)

HSA states Class A medical devices are exempt from product registration. However, if you manufacture or import Class A devices, you must submit a product notification application in SHARE.

Key implications:

• Class A still appears in the Class A Medical Device Database
• Do not skip notification because the device is "low risk"
• Dealer licence still required for import/manufacture/supply activities

Class B, C, D — product registration and evaluation routes

Class B, C, and D devices require product registration via SHARE using the appropriate evaluation route:

HSA publishes route eligibility, excluded device types, and reference agencies on its registration overview. Devices approved as Class I or Class II exempt in reference agencies do not qualify for abridged/expedited/immediate routes based on those approvals alone.

Registration dossiers follow the ASEAN Common Submission Dossier Template (CSDT) format.

Step-by-step market access workflow

1. Classify the device under HSA rules (A/B/C/D).
2. Determine company role — manufacturer, importer, or wholesaler.
3. Apply for dealer licence in SHARE if you will manufacture/import/supply.
4. For Class A: submit product notification in SHARE.
5. For Class B/C/D: select evaluation route → prepare CSDT dossier → submit new product registration in SHARE.
6. Upon approval, maintain change notifications, retention, and cancellation obligations as applicable.
7. Verify public listing in SMDR (Class B/C/D) or Class A database.

Decision tree

Will you manufacture, import, or supply medical devices in Singapore?
├─ No → Dealer licence not required for your role
└─ Yes → Apply for dealer licence in SHARE
         └─ What class is the device?
             ├─ Class A → Product notification in SHARE (registration exempt)
             └─ Class B/C/D → Product registration in SHARE (select evaluation route)

Checklist

• HSA device class confirmed (A/B/C/D)
• Company role identified (manufacturer/importer/wholesaler)
• Dealer licence applied or held
• Class A notification submitted (if applicable)
• Class B/C/D evaluation route selected
• CSDT dossier prepared
• SHARE Corppass access configured
• Reference agency approvals verified for expedited routes
• SMDR / Class A database listing verified post-approval

Common pitfalls

1. Assuming Class A needs no HSA filing — notification is still required.
2. Confusing dealer licence with product registration — both may be required.
3. Using MEDICS after SHARE cutover — new applications go to SHARE.
4. Choosing expedited route without eligible reference approval — leads to rejection or re-routing.
5. Reference approval on different intended use — must match Singapore labelled use.
6. Ignoring change notification obligations after initial approval.

FAQ

Do Class A devices need HSA registration?

No full registration — but product notification in SHARE is required when you manufacture or import Class A devices.

What is SHARE for medical devices?

SHARE is HSA's portal for product registration, Class A notification, dealer licences, change of registrant, and related services.

Can I import Class B devices without a dealer licence?

No — companies need a dealer's licence before importing or supplying medical devices.

What dossier format does HSA use?

ASEAN CSDT for Class B, C, and D registration submissions.

What evaluation routes exist for Class C and D?

Full, abridged, and expedited (ECR/EDR) routes depending on reference agency approvals and device type.

When did SHARE replace MEDICS?

HSA announced SHARE launch for new medical device submissions from 14 July 2025.

Official sources

• HSA — Regulatory overview: https://www.hsa.gov.sg/medical-devices/regulatory-overview
• HSA — Registration overview: https://www.hsa.gov.sg/medical-devices/registration/overview
• HSA — SHARE (Medical Device): https://www.hsa.gov.sg/e-services/share-medical-device/
• HSA — Dealer licence: https://www.hsa.gov.sg/medical-devices/manufacturing-import-and-supply/dealers-licence/
• HSA — SHARE announcement: https://www.hsa.gov.sg/announcements/introducing--share----your-digital-portal-for-medical-devices/