HSA GN-15 R14: Annex 4 and Registration Requirements

Singapore's Health Sciences Authority (HSA) has issued Revision 14 of GN-15, its medical device product registration guidance, effective 14 September 2026. The revision includes an Annex 4 declaration covering device labelling, adverse events and field safety corrective actions (FSCAs). Applicants should use the updated submission checklists for Class B, C and D devices, including those taking the Full evaluation route.

GN-15 is administrative guidance for registration applicants. The revision date is not a new statutory commencement date or a deadline to re-register devices already on the market. HSA marks revised passages in the document; the practical points below concern the new declaration, the current Priority Review criteria and the Immediate Class C Registration (ICR) safety criterion.

Annex 4 applies across the listed registration routes

Item 6 in Annex 6, page 45, and Annex 8, page 49, requires the declaration for every route listed in those Class B/C/D checklists:

The restriction to Priority Review Scheme Route 1 belongs to item 7, the justification for an unmet clinical need, not to the Annex 4 declaration in item 6. An ordinary Full-route application therefore also needs Annex 4. These tables concern Class B/C/D registration; they do not establish an Annex 4 requirement for Class A notifications.

The standalone Annex 4 template, also reproduced on pages 42–43 of GN-15, uses the product owner's letterhead, identifies the devices covered and requires a senior company official's signature. Its two sections have different scopes:

• Section 1 applies to Abridged, Expedited and Immediate applications. It asks whether the Singapore labelling, packaging and instructions for use match the versions approved by the reference agencies supporting the application. Differences must be described in the comparison table. Declaring a difference does not itself establish eligibility for a reliance-based route.
• Section 2 applies to all applications covered by the declaration. It asks for the applicable checkbox or checkboxes and the relevant device lists: either no reportable adverse events and FSCAs, or details of reported events and conducted FSCAs. The no-event attestation refers to global commercial distribution from a specified month and year, or the last five years, and is expressly not confined to use as intended by the product owner.

The disclosure tables request affected device names or identifiers, adverse-event reports relative to units distributed globally over the stated period, and FSCA dates, reasons, countries and open or closed status. The corrective and preventive action summary and effectiveness field applies to open FSCAs only. The template does not explain how to select between its since-launch and five-year formulations; applicants should document the period used and resolve any uncertainty with HSA before signing.

Priority Review: six focus areas and an unmet clinical need

Section 7 marks an updated Route 1 list containing oncology, diabetes, ophthalmic diseases, cardiovascular diseases, infectious diseases and skin diseases. The device must also address an unmet clinical need: no existing alternative treatment or diagnostic method for the purpose, or a breakthrough technology with a clinically meaningful advantage over an existing legally marketed technology.

The scheme concerns Class B/C/D applications under the Full route. Route 2 is available to devices that do not satisfy Route 1's criteria. GN-15 excludes devices incorporating registrable therapeutic or medicinal products. HSA's Priority Review page describes opting in at submission.

Route 1 has a lower evaluation fee than Route 2, but both priority routes have the same published turnaround time. The current HSA fee schedule lists:

The separate application fee is SGD 560. Published turnaround times exclude time spent awaiting the applicant's response to HSA questions. These are existing published fees, not fee changes introduced by GN-15 R14.

ICR eligibility and Annex 4 answer different questions

ICR is limited to Class C standalone medical mobile applications, rather than software medical devices generally. Page 26 requires, at submission, at least one independent reference-agency approval for an identical labelled use; the specified global safety record; and no relevant rejection or withdrawal for quality, performance, efficacy or safety reasons, including refusal to register specific models.

The R14-marked safety criterion uses a period of the last three years or since global market introduction. It concerns intended use and specifies no reported deaths, no reported serious deterioration in health, and no open FSCAs, including recalls, at submission. This is not a blanket requirement that the device has never had any adverse event or closed FSCA.

Annex 4's broader disclosure and the separate Annex 3 no-safety-issues declaration must each be addressed where the checklist requires them. Neither replaces the other.

What applicants should prepare

Pure Global analysis: Build the submission plan around the route checklist first, then assign the product-owner signature and evidence collection for Annex 4. Reconcile the declaration with global vigilance records and the Singapore labelling set. For ICR, assess route eligibility separately from the broader disclosure so that a reported event is neither omitted nor automatically treated as disqualifying without applying HSA's actual criteria.

For skin-disease devices, document both the focus-area fit and the unmet clinical need before selecting Route 1. Its financial advantage over Route 2 is supported by the fee schedule; a faster Route 1 timeline than Route 2 is not. This review did not obtain a complete R13 copy, so it does not claim an exhaustive before-and-after comparison or that skin-disease eligibility first began on 14 September.

See the Singapore market overview and HSA glossary for related market-entry context.