Singapore’s Health Sciences Authority (HSA) has released Revision 12 (R12) of its foundational registration guidance, GN-15: Guidance on Preparation of a Product Registration Submission for General Medical Devices. Published in August 2025, this update consolidates the country’s regulatory expectations for both general medical devices and in vitro diagnostic (IVD) devices under the Health Products Act and Health Products (Medical Devices) Regulations.
The revision introduces several important administrative updates and modernizes submission procedures through HSA’s new digital system, the Singapore Health Product Access and Regulatory E-System (SHARE). By streamlining the submission and review process, HSA aims to align more closely with ASEAN and IMDRF standards and strengthen consistency across guidance documents such as GN-12, GN-13, GN-14, and GN-21.
For manufacturers and registrants planning market entry into Singapore, GN-15 R12 is an essential reference that defines how to classify, group, and register devices efficiently while maintaining compliance with local regulatory requirements.
Purpose and Scope
The purpose of GN-15 R12 is to guide applicants through the preparation of a product registration submission for new medical devices in Singapore. The document explains the applicable legal basis under the Health Products Act and clarifies that all medical devices, unless explicitly exempt, must be registered with HSA before they can be supplied in the local market.
This guidance applies to all new registrations and should be read together with related documents governing device grouping (GN-12), classification (GN-13 and GN-14), and dossier preparation (GN-17 and GN-18). It also references GL-07, which covers software as a medical device (SaMD) and clinical decision support software (CDSS).
Importantly, R12 is the first version to explicitly reference SHARE, now the central platform for electronic submissions, document uploads, and payment transactions.
Classification and Grouping Requirements
Before submitting a registration application, manufacturers must determine how their device fits within Singapore’s classification framework. Devices are assigned to one of four risk classes (A–D) according to GN-13 (for general medical devices) or GN-14 (for IVDs). The classification determines the evaluation route, the evidence required, and the applicable regulatory controls.
Equally important is the concept of device grouping, which dictates how related products can be registered together. Devices may be submitted as a single product, family, system, or group, but only one grouping is permitted per application. All items within that grouping must share core design, intended use, and performance characteristics.
HSA emphasizes that accurate classification and grouping are crucial. Misclassification can lead to re-routing of applications, delayed evaluations, or the need to reapply entirely, each with new fees and timelines. Proper preparation at this stage ensures smoother evaluation and faster market entry.
Evaluation Routes: A Confidence-Based Framework
HSA continues to apply a confidence-based evaluation framework, which tailors regulatory oversight according to a product’s risk and regulatory history. GN-15 R12 outlines three main evaluation routes: Immediate Class B Registration (IBR), Abridged Evaluation, and Full Evaluation.
The Immediate Class B Registration (IBR) pathway allows for immediate listing of eligible Class B devices upon successful submission and payment through SHARE. This fast-track route is available only when all eligibility conditions are satisfied, such as prior approval by recognized authorities and a proven safety record.
However, HSA retains the right to verify documentation after registration and may impose additional conditions, or even cancel the listing, if ineligibility is detected. Fees for IBR applications are not refundable, emphasizing the need for applicants to confirm eligibility in advance.
For devices that meet eligibility criteria but require limited review, the Abridged Evaluation route remains available. This pathway applies to devices approved by reference regulatory agencies and supported by acceptable marketing history without major safety concerns.
It offers reduced data requirements compared to a Full Evaluation while maintaining HSA’s assurance of product quality and safety. Finally, devices that are novel, high-risk, or lack qualifying prior approvals undergo the Full Evaluation process.
This comprehensive route demands complete technical documentation and is often applicable to new technologies or devices first introduced to market.
Submission Process through SHARE
All product registration applications must now be submitted through SHARE, which serves as Singapore’s single portal for medical device regulatory activities. Applicants must upload all dossier materials and supporting documents in electronic form, following the platform’s structured folders and naming conventions.
Upon submission, an application fee is charged. HSA will then conduct a preliminary review to verify completeness and confirm that the correct evaluation route has been selected.
If re-routing is necessary, the applicant must pay the applicable evaluation fees for the new route. Once accepted for evaluation, additional evaluation fees are charged, and these too are non-refundable.
For Immediate Class B submissions, successful payment results in automatic registration and listing in the Singapore Medical Device Register (SMDR). Nonetheless, HSA retains authority to conduct post-submission verification and may revoke registrations found to be non-compliant.
Applicants are therefore encouraged to maintain meticulous records (such as Essential Principles checklists and supporting evidence) to substantiate their submission when requested.
Dossier Format and Documentation Standards
The technical dossier remains the cornerstone of any registration application. Under GN-15 R12, applicants must structure their dossier according to either the ASEAN Common Submission Dossier Template (CSDT) or the IMDRF Table of Contents (ToC) format.
Both formats are accepted, provided they allow traceability between the device’s intended use, Essential Principles compliance, and supporting technical evidence. Each dossier should contain detailed descriptions of the device design and specifications, results of verification and validation testing, and risk management documentation.
Clinical or performance data must be included when relevant, especially for higher-risk devices. Other essential components include labelling, manufacturing information, quality management system (QMS) certificates, and, where applicable, marketing history and safety declarations.
The emphasis in this revision is on completeness and traceability. HSA highlights that incomplete dossiers or those with missing evidence are among the most common causes of evaluation delays.
Special Considerations for Combination and Software Devices
GN-15 R12 devotes specific attention to complex product types. For devices that incorporate medicinal substances, applicants must submit additional documentation demonstrating compliance with both medical device and medicinal product regulatory requirements.
Coordination with the relevant product divisions may be required to ensure full evaluation of the combination product. For software-based medical devices, including SaMD and CDSS, HSA directs applicants to GL-07.
The guidance reiterates that software algorithms must be validated in proportion to their intended use and potential risk, and any future modifications should follow appropriate change control and documentation procedures.
Administrative Timelines, Fees, and Post-Approval Responsibilities
The updated guidance also clarifies Singapore’s administrative expectations. Processing timelines, known as Turn-Around Times (TATs), are measured from the date an application is received, excluding “stop-clock” periods when applicants are responding to HSA queries.
The most current TAT targets are maintained on HSA’s website. All application and evaluation fees are non-refundable, even if an application is withdrawn after acceptance.
Post-approval, registrants must maintain the device listing in the SMDR, pay annual retention fees, and report any product changes in accordance with GN-21 (Change Notification). Failure to maintain compliance can result in suspension or cancellation of the device’s registration.
What’s New in Revision 12
The August 2025 revision introduces several notable changes. Most prominently, it officially integrates SHARE as the central submissions platform, replacing previous fragmented systems.
The guidance also tightens requirements for Immediate Class B Registration, clarifying that post-submission verification is mandatory and ineligibility will result in immediate cancellation without refund. In addition, Annexes 4–7 have been updated to provide clearer overviews of documentation and evaluation routes for Class B, C, and D devices.
Administrative clarifications now specify that turn-around times are published on HSA’s website, rather than within the guidance itself, and that both application and evaluation fees are non-refundable. These changes reflect HSA’s effort to simplify navigation, improve transparency, and encourage careful pre-submission planning by applicants.
Key Takeaways for Manufacturers
For manufacturers preparing to register devices in Singapore, GN-15 R12 reinforces several priorities: accuracy in classification and grouping, completeness of the technical dossier, and strict adherence to administrative requirements. Before submission, applicants should confirm that their device’s risk class and grouping align with HSA definitions, verify eligibility for their chosen evaluation route, and ensure that all required evidence is ready for upload through SHARE.
Timely responses to queries and proactive management of post-approval obligations will also help minimize delays and maintain regulatory compliance. Given Singapore’s continued alignment with ASEAN and IMDRF frameworks, following these best practices will position manufacturers for efficient market entry and sustainable product lifecycle management within the region.
Conclusion
The release of GN-15 R12 marks another step in Singapore’s broader digital and regulatory modernization strategy. By moving all device registrations to the SHARE platform and refining evaluation procedures, HSA is enhancing both efficiency and regulatory confidence.
For the industry, this update is more than an administrative adjustment, it reflects Singapore’s ongoing commitment to harmonization, transparency, and risk-based regulation. Manufacturers that align their internal documentation and processes with these new expectations will not only accelerate approvals but also strengthen their readiness for future ASEAN and global submissions.
