Step-by-Step Guide to Declaring Class A Medical Devices in Singapore (HSA Requirements)

Declaring Class A medical devices in Singapore may be one of the simplest regulatory pathways under HSA, but it is far from a formality. Even though Class A devices are exempt from product registration, manufacturers and importers must still complete a mandatory device notification (declaration) before supplying these products in the market.

This step isn’t just about compliance. It ensures market transparency, traceability, and patient safety, aligning every device with the Essential Principles for Safety and Performance. Whether you’re a new entrant to Singapore’s medical device landscape or a seasoned industry player updating your internal processes, understanding the exact steps involved in the SHARE submission, QMS expectations, sterility requirements, and ongoing dealer obligations is critical.

This guide breaks down the entire declaration process in a clear, practical format, helping organisations meet regulatory expectations confidently and efficiently.

Step by Step Guide to Declaring Class A Medical Device

1. Obtain Your HSA Dealer’s Licence & Set Up a QMS

Before dealing with any Class A device, you must be a licensed dealer under HSA—either as a manufacturer or importer. HSA also requires dealers to maintain an appropriate Quality Management System (QMS) to control the manufacturing, importation, and distribution of Class A medical devices.

2. Verify Essential Safety & Performance Compliance

All Class A devices must meet HSA’s Essential Principles for Safety and Performance before being supplied in Singapore. Manufacturers and importers must confirm that the device is safe, fit for its intended purpose, and aligned with recognised quality and performance requirements.

3. Confirm Sterilisation Standards (If the Device Is Supplied Sterile)

If your Class A device is supplied sterile, the sterilisation process must comply with established international standards, including:

• ISO 11135 (Ethylene oxide)

• ISO 11137 (Radiation)

• ISO 17665 (Moist heat)

• ISO 13408 (Aseptic processing)

Dealers must maintain evidence that sterilisation methods meet these global benchmarks.

4. Submit Your Class A Device List Through SHARE

All Class A devices intended for manufacture or import must be declared via HSA’s SHARE portal through a Product Notification application. This electronic submission acts as the official declaration and creates a formal record with HSA.

5. Ensure the Device List Is Submitted Before Import or Supply

Your Class A device list must be complete and up-to-date before importing or supplying any device in Singapore. Timely submission is a core licensing requirement.

6. Maintain Accuracy & Update the List Regularly

Licensed manufacturers and importers must ensure the submitted information remains accurate and current at all times. Any new devices, discontinued items, or data changes must be promptly updated in the SHARE system to remain compliant with HSA’s licensing conditions.

What Happens After the Declaration?

Published in HSA’s Class A Medical Device Database

Once submitted, your devices will appear in the public Class A Medical Device Database, improving transparency for users, distributors, and healthcare providers.

Ongoing Compliance Obligations Still Apply

Even though Class A devices don’t require product registration, dealers must still comply with all regulatory duties, including:

• Maintaining distribution and complaint records

• Reporting adverse events (AE) to HSA

• Notifying HSA of Field Safety Corrective Actions (FSCA)

Regulatory responsibilities continue throughout the device’s lifecycle.

Conclusion

Declaring a Class A medical device in Singapore is a straightforward process but only when each compliance requirement is clearly understood and consistently maintained. From securing the right dealer licence and verifying safety and performance requirements to submitting accurate device lists through SHARE and keeping up with ongoing reporting duties, every step plays a vital role in ensuring patient safety and regulatory transparency.

By following this structured approach, manufacturers and importers not only meet HSA’s mandatory expectations but also strengthen their internal controls, documentation discipline, and market credibility. As regulations continue to evolve, staying proactive, well-informed, and audit-ready will help your organisation maintain smooth operations and avoid compliance gap.

10 FAQs: Class A Medical Device Declaration (Singapore, HSA)

1. Do Class A medical devices in Singapore require product registration?

No. Class A medical devices are exempt from formal product registration, but HSA still requires a mandatory device notification (declaration) before the device is manufactured, imported, or supplied in Singapore.

2. Who must submit the Class A device declaration to HSA?

Both manufacturers and importers must submit the declaration. They must also hold a valid HSA dealer’s licence and maintain a Quality Management System (QMS) as part of their licensing requirements.

3. What information must be provided during the Class A device notification?

Dealers must submit a device list through the SHARE portal, including device name, intended purpose, device type, sterility status, and manufacturer details. This submission is made via a Product Notification application.

4. When must the Class A device list be submitted?

The declaration must be completed before the device is imported or supplied in Singapore. Dealers must also keep the list accurate and up-to-date at all times in accordance with HSA licensing conditions.

5. Are sterile Class A devices subject to additional requirements?

Yes. If the device is supplied sterile, the sterilisation process must comply with recognised international standards, such as ISO 11135, ISO 11137, ISO 17665, and ISO 13408, or an equivalent validated method.

6. Where is the declared Class A device information published?

All declared Class A devices are published on HSA’s Class A Medical Device Database, making the information publicly accessible for traceability and market transparency.

7. What ongoing obligations do dealers have after the device is declared?

Dealers must continue to meet all regulatory obligations, including:

• Maintaining distribution, complaint, and traceability records

• Reporting adverse events (AE)

• Notifying HSA of any Field Safety Corrective Actions (FSCA)

These obligations apply even though the device is exempt from product registration.

7. What ongoing obligations do dealers have after the device is declared?

Dealers must continue to meet all regulatory obligations, including:

• Maintaining distribution, complaint, and traceability records

• Reporting adverse events (AE)

• Notifying HSA of any Field Safety Corrective Actions (FSCA)

These obligations apply even though the device is exempt from product registration.

8. Can the device declaration be updated after submission?

Yes. Dealers are required to promptly update the SHARE submission whenever new devices are added, products are discontinued, or information changes. Maintaining accuracy is a mandatory licensing requirement.

9. Is the Class A declaration process the same for local manufacturers and importers?

Yes. Both local manufacturers and importers must follow the same notification process, meet the Essential Principles for Safety and Performance, and ensure compliance with ongoing regulatory duties.

10. What happens if a dealer fails to declare a Class A device?

Failure to declare a Class A device before supply may lead to non-compliance with HSA regulations, affecting dealer licence conditions and resulting in potential enforcement actions.