Singapore Class A Medical Device Notification: HSA SHARE Product Notification Guide

Quick answer

Do Class A medical devices need HSA registration in Singapore?

No — Class A (low-risk) medical devices are exempt from product registration in Singapore. However, manufacturers and importers must still submit a product notification through SHARE (Singapore Health Product Access and Regulatory E-System) before supplying the device. You also need a valid medical device dealer's licence (manufacturer, importer, or wholesaler licence as applicable) applied via the same SHARE portal. From 14 July 2025, SHARE replaced the legacy MEDICS system for Class A notifications, Class B/C/D registrations, dealer licences, and related services. Class A dealers may satisfy quality requirements with a Declaration of Conformity to a Quality Management System (QMS) rather than ISO 13485 certification required for higher-risk manufacturing activities. After notification, Class A devices appear in HSA's Class A Medical Device Database and related public registers.

Who this applies to

This guide is for regulatory affairs teams, Singapore-based dealers, and foreign manufacturers placing Class A medical devices on the Singapore market.

Product scope: Class A non-IVD medical devices under HSA's risk classification framework (lowest risk class). Class B, C, and D devices follow product registration routes instead of notification — do not use this workflow for higher-risk products.

Out of scope: In vitro diagnostic (IVD) products, pharmaceuticals, health products outside HSA medical device definition, and Class A devices supplied only for export without local distribution (confirm export-only arrangements with HSA guidance).

Class A notification vs Class B/C/D registration

Understanding the regulatory split prevents costly filing errors.

HSA's registration overview states explicitly that Class A devices are exempted from product registration but require product notification for devices you manufacture or import.

Dealer licence prerequisites

Before notifying a Class A device, your Singapore entity must hold the appropriate dealer's licence applied through SHARE.

Licence types

You need a dealer's licence if you manufacture, import, or wholesale medical devices in Singapore — regardless of class.

Quality Management System (QMS) requirements

QMS documentation varies by licence type and device class handled:

HSA requires companies dealing in medical devices to establish and maintain an appropriate QMS consistent with regulatory requirements. Upload supporting documents during dealer licence application in SHARE.

Licence maintenance

After approval, you must notify HSA of changes to licence details — including medical device risk classification scope, QMS certification, and site details — and renew the dealer's licence on time to continue dealing.

SHARE portal overview (from 14 July 2025)

SHARE is HSA's digital portal for medical device regulatory transactions. From 14 July 2025, it replaced MEDICS for new submissions.

Access and authentication

• Log in to SHARE using Corppass (Singapore corporate digital identity).
• URL: https://www.hsa.gov.sg/e-services/share-medical-device/

SHARE services relevant to Class A

New application submissions after the go-live date must use SHARE — not MEDICS.

Step-by-step: Class A product notification in SHARE

Follow this sequence when bringing a new Class A device to the Singapore market.

Step 1: Confirm Class A classification

Use HSA's classification rules to verify the device is Class A (not Class B). Misclassification leads to rejected notifications or compliance findings. Cross-check intended purpose, duration of use, invasiveness, and active/non-active status against HSA guidance.

Step 2: Obtain or verify dealer's licence

Apply for the correct dealer's licence in SHARE if you do not already hold one:

1. Prepare QMS documentation (Declaration of Conformity for Class A-only dealing).
2. Upload required supporting documents per licence type.
3. Submit new dealer licence application in SHARE.
4. Wait for HSA approval before supplying devices.

Step 3: Prepare product notification content

Gather device identification and regulatory details HSA expects in the notification form:

• Product name and model identifiers
• Manufacturer name and address
• Device classification confirmation (Class A)
• Intended purpose aligned with labelling
• GMDN or relevant nomenclature if required in form
• Reference to applicable conformity evidence (device must meet Essential Principles)

Ensure labelling and Instructions for Use comply with HSA requirements before supply.

Step 4: Submit new product notification in SHARE

1. Log in to SHARE with Corppass.
2. Navigate to Product Notification → New notification.
3. Complete all mandatory fields for the Class A device.
4. Upload supporting documents as prompted.
5. Pay applicable fees if required.
6. Submit and retain the SHARE acknowledgement reference.

Step 5: Supply only after notification acceptance

Do not place the Class A device on the market until HSA processes the notification. Importers must ensure foreign manufacturers provide accurate technical and labelling information for the notification record.

Step 6: Maintain and amend records

Use SHARE to:

• Amend notifications when models, labelling, or manufacturer details change
• Cancel notifications when discontinuing supply
• Verify public listing in the Class A Medical Device Database

Step 7: Renew dealer licence and respond to HSA queries

Track dealer licence expiry and renew via SHARE. Respond promptly to HSA information requests — failure to maintain licence validity or notification accuracy can affect supply legality.

Amendment and cancellation workflows

Always update both product notification and dealer licence records when site or QMS scope changes affect the device.

Checklist

Use this checklist before first supply of a Class A device in Singapore:

• Device confirmed as Class A under HSA classification rules
• Valid dealer's licence (manufacturer/importer/wholesaler) active in SHARE
• QMS documentation uploaded (Declaration of Conformity for Class A-only scope)
• Product notification submitted and accepted in SHARE
• Labelling and IFU reviewed against HSA requirements
• Device listed in Class A Medical Device Database (verify after processing)
• Internal records link SHARE reference to import/manufacturing batch traceability
• Process defined for amendment/cancellation when details change

Common pitfalls

1. Assuming Class A needs no HSA filing — notification is mandatory even though registration is exempt.
2. Using MEDICS after July 2025 — new submissions must go through SHARE with Corppass.
3. Submitting product registration for Class A — wrong pathway; use product notification instead.
4. Supplying before notification acceptance — market placement requires completed notification workflow.
5. Missing dealer licence — notification alone is insufficient without licensed dealing status.
6. ISO 13485 over-documentation for Class A-only importers — Declaration of Conformity may suffice; verify current HSA dealer licence guide.
7. Treating Class B accessories as Class A — reclassify before filing; accessories may need separate registration.
8. Ignoring licence renewal — expired dealer licence invalidates lawful supply even if notification record exists.

FAQ

Do Class A medical devices need HSA registration in Singapore?

No. HSA exempts Class A devices from product registration, but manufacturers and importers must submit a product notification through SHARE before supply. A valid dealer's licence is also required.

What is the difference between product notification and product registration?

Product notification applies to Class A devices — a lighter pre-market record in SHARE. Product registration applies to Class B, C, and D devices and involves full HSA evaluation before SMDR listing.

How do I submit a Class A notification in SHARE?

Log in with Corppass at HSA's SHARE medical device portal, select Product Notification → New notification, complete device and manufacturer details, upload supporting documents, and submit. Ensure your dealer's licence is already active.

When did HSA launch SHARE for medical devices?

HSA launched SHARE for medical devices on 14 July 2025, replacing MEDICS for new product notifications, registrations, dealer licence applications, and related services.

What dealer licence do I need to import Class A devices?

You need an importer dealer's licence applied through SHARE. If you also manufacture or wholesale, apply for the corresponding licence type. Each licence requires appropriate QMS documentation.

What quality system documentation is required for Class A dealers?

For companies dealing with Class A medical devices only, HSA accepts a Declaration of Conformity to a QMS (importer/wholesaler) or Declaration of Conformity to ISO 13485 (manufacturer). Higher-risk device dealing requires ISO 13485 from a SAC-accredited certification body or MDSAP.

Official sources

• Health Sciences Authority — Registration overview of medical devices (Class A exemption and notification): https://www.hsa.gov.sg/medical-devices/registration-of-medical-devices/register-your-device/overview/
• Health Sciences Authority — SHARE (Medical Device): https://www.hsa.gov.sg/e-services/share-medical-device/
• Health Sciences Authority — Introducing SHARE (14 July 2025): https://www.hsa.gov.sg/announcements/introducing--share----your-digital-portal-for-medical-devices/
• Health Sciences Authority — Apply for a medical device dealer's licence: https://www.hsa.gov.sg/medical-devices/manufacturing-import-and-supply/dealers-licence/apply/
• Health Sciences Authority — Importer, wholesaler and manufacturers' licensing: https://www.hsa.gov.sg/medical-devices/dealers-licence