Singapore Updates GN-15 Medical Device Registration Guidance

On September 30, 2026, Singapore’s Health Sciences Authority (HSA) published Revision 15 of GN-15: Guidance on Medical Device Product Registration. Effective October 1, 2026, the revision introduces important updates to registration documentation, Software as a Medical Device (SaMD), AI-enabled medical devices, software change notifications, and post-market compliance.

Compared with Revision 14 and earlier versions, Revision 15 provides a more structured approach to registration declarations and places greater emphasis on software lifecycle management, digital traceability, and connected-device security.

Manufacturers preparing new applications or maintaining medical devices in Singapore may need to review how regulatory authorization, marketing history, safety information and software changes are documented.  

Standardized Registration Templates: Greater Consistency, Clearer Accountability

Revision 15 introduces a more structured annex framework for declarations submitted as part of medical device registration. While earlier versions provided standardized declaration forms, Revision 15 establishes a clearer framework for grouping authorization, marketing history, safety information, and device-related post-market declarations.

The four annexes are:

• Annex 1: Letter of Authorisation – Formal authorization documentation.
• Annex 2: Marketing History Declaration – Marketing history statements that should correspond with the supporting evidence provided.
• Annex 3: Safety Declaration – Safety information that should accurately reflect available adverse-event and corrective-action records.
• Annex 4: Device Labelling, Adverse Events and Field Safety Corrective Actions Declaration – Consolidates device labeling, adverse events, and Field Safety Corrective Actions (FSCAs) into a single declaration.

The key consideration is consistency across the registration dossier.

Product names, models, intended uses, company details, and regulatory approvals should align across all annexes and the supporting registration dossier. Labeling information should also be consistent with the proposed Singapore labeling and the device’s broader safety history.

SaMD and AI: Stronger Focus on Software Lifecycle Management

For manufacturers of SaMD and AI-enabled medical devices, Revision 15 places greater emphasis on demonstrating control over software throughout its lifecycle. The updated approach also reflects closer alignment with Singapore's Artificial Intelligence in Healthcare Guidelines (AIHGIe) 2.0 and dedicated regulatory considerations for SaMD.

Technical documentation should address several key areas:

• Algorithm verification and validation.
• Software version identification and control.
• Data-drift monitoring and mitigation.
• Software update management.
• Ongoing performance monitoring.

Manufacturers should be able to identify precisely which software version is intended for the Singapore market and demonstrate that the supporting verification and validation evidence applies to that version.

For AI-enabled products, this also means addressing how performance will be monitored when real-world data differs from the datasets used during development and validation. Appropriate controls should be in place to identify and manage potential data drift that could affect device performance or safety.

Software version information should remain consistent across:

• The registration application
• Verification and validation evidence
• Product labeling and instructions
• The software released in Singapore
• Records of subsequent updates

Software Changes: When Is Regulatory Notification Required?

Revision 15 establishes a more structured Change Notification process for software changes, providing greater clarity around the regulatory assessment of software updates, including changes to existing versions.

Before implementing an update, manufacturers should assess whether it affects the device’s intended use, safety, performance, or registered software version.

A change regarded as minor by the development team may still have regulatory implications. Manufacturers should therefore document the assessment and determine whether notification is required before releasing the update in Singapore. This makes it particularly important to integrate regulatory review into software development and change-control procedures rather than treating updates as purely technical decisions.

Post-Market Reporting and Connected Devices: Traceability and Security Matter

Revision 15 reinforces the importance of post-market surveillance, digital traceability, and cybersecurity for connected medical devices, placing greater emphasis on timely reporting and controls that support ongoing product safety.

Adverse Event Reporting

Serious adverse events presenting a public-health threat may be subject to a 48-hour reporting window.

Manufacturers and their Singapore-based partners should have clearly defined procedures for:

• Receiving and recording product complaints.
• Assessing whether an event meets reporting criteria.
• Escalating potentially reportable events promptly.
• Submitting required information within the applicable reporting timeframe.

Responsibilities should be clearly divided between the product owner, registrant, and commercial partners. This is particularly important when a complaint is first received outside Singapore or by a distributor that is not responsible for submitting the report.

Cybersecurity and Connected Devices

For connected medical devices, cybersecurity is an important part of ongoing safety and performance management.

Manufacturers should maintain appropriate controls to identify vulnerabilities, assess their potential impact on device safety and performance, and implement corrective actions where necessary.

These processes should support the ongoing assessment of cybersecurity risks throughout the device lifecycle rather than being limited to pre-market development.

Unique Device Identification (UDI)

UDI requirements should also form part of the manufacturer's broader traceability strategy.

Device identifiers should remain consistent across registration records, product labeling, and relevant distribution records, supporting effective product identification and traceability throughout the supply chain.

Preparing for GN-15 Revision 15

With the revised guidance now effective, manufacturers should assess their existing Singapore registration documentation and compliance procedures against the updated expectations.

Rather than relying on application forms and technical files prepared under an earlier version, companies should conduct a targeted review covering:

• Use of the latest annex templates
• Consistency between declarations and supporting documents
• Completeness of marketing and safety information
• SaMD and AI validation evidence
• Software version and change controls
• Adverse-event and FSCA reporting procedures
• Cybersecurity and UDI readiness

Importantly, the revision does not necessarily mean that all existing documentation must be replaced. Previously generated evidence may remain suitable, provided it is reviewed against the updated requirements and presented in the revised documentation structure.  

Final Thoughts

GN-15 Revision 15 brings greater structure to Singapore medical device registration while reinforcing HSA's expectations around software lifecycle management, AI performance, and post-market compliance. Its closer alignment with AIHGIe 2.0 and more structured approach to software change notifications also highlight the importance of maintaining regulatory oversight throughout a device's lifecycle.

The extent of the work required will depend on the type of device and its existing documentation. Conventional medical device manufacturers may mainly need to update declarations and check dossier consistency, whereas SaMD and AI manufacturers may need to undertake a more extensive review of algorithm validation, software version control, and data-drift management.

Understanding where these changes affect existing documentation and processes is therefore an important first step towards maintaining compliance. Cisema helps manufacturers navigate these requirements through registration dossier reviews, declaration updates, and regulatory assessments aligned with HSA’s revised guidance.  

To discuss your regulatory requirements and how we can support your medical device registration in Singapore, contact Cisema today.

Further Information

• Explore Cisema’s Singapore medical device registration services.
• Read Cisema’s guide to Singapore’s HSA medical device registration process.

References

• Health Sciences Authority, Guidance Documents for Medical Devices.
• Health Sciences Authority, GN-15: Guidance on Medical Device Product Registration, Revision 15.