HSA GN-15 R15 Adds Checklist and Updates Accreditation References

Singapore's Health Sciences Authority (HSA) has issued GN-15 Revision 15, effective 1 October 2026, together with a new Premarket Submission Checklist (MD-01 R1), alongside Revision 5 of the GN-17 and GN-18 submission guidances. These are administrative registration guidances, not statutes. The checklist and quality management system (QMS) evidence wording affect dossier preparation. HSA provides the documents and templates in its official guidance index.

Change 1: the Premarket Submission Checklist

GN-15's Class B and Class C/D submission tables now list the Premarket Submission Checklist as item 1 for the Full and Abridged Class B routes and the Full, Abridged, ECR and EDR Class C/D routes. The checklist itself states that it is not applicable to Immediate-route applications.

The checklist's instruction is blunt: do not submit if any required document is unavailable, because "incomplete submissions will be rejected and fees paid will not be refunded". Its non-exhaustive examples of an incomplete submission include:

• the checklist missing, incomplete or only partially filled in;
• required SHARE folders left empty;
• an Annex 2 List of Configurations that does not tally with SHARE data;
• documents uploaded to the wrong SHARE folder, or to "Others" when a proper folder exists;
• placeholder files indicating documents will be provided later; and
• empty Section 8 folders without justification in the checklist.

Section 8 covers design verification and validation evidence such as biocompatibility, sterilization, shelf life, electrical safety, electromagnetic compatibility, software, cybersecurity and machine learning. Where a section does not apply, the applicant must say why — the checklist's own example is no biocompatibility data because the device is not patient-contacting.

The Annex 2 template must be submitted as a Microsoft Excel file and must exclude Class A devices and non-medical devices. Applications containing implants use the file-mapping tab for every listed model, including accessories. Devices involving software must state the exact software version to be supplied in Singapore.

Change 2: the accreditation reference for ISO 13485 certificates

GN-15 R15's Annex 6 and Annex 8, and the manufacturer-information sections of GN-17 R5 and GN-18 R5, now carry the same condition: certification bodies for ISO 13485 must be accredited by Global ACI-recognized accreditation bodies, or be EU MDR/IVDR notified bodies. In GN-15 R14, those footnotes already required accreditation by IAF-recognized accreditation bodies or EU MDR/IVDR notified body status. R15 changes the network reference to Global ACI; it does not introduce accreditation as an entirely new condition. GN-17 and GN-18 also mark the Global ACI reference as an R5 change.

The guidances still list Medical Device Single Audit Program (MDSAP) certificates as QMS evidence. For sites without ISO 13485 or MDSAP certification, comparable audit reports — the guidances name US FDA Quality System Regulations and Japan MHLW Ordinance 169 — can still be submitted.

What applicants should do

Pure Global analysis: the checklist converts HSA's folder-mapping and completeness expectations into an explicit screening document. The checklist restates a financial consequence for incomplete submissions; non-refundable fees were already described in GN-15 R14, Section 10. Before filing, reconcile the checklist, the Annex 2 Excel sheet and the SHARE folder structure against each other, and document every "not applicable" answer in Section 8.

For QMS evidence, verify the accreditation status of every ISO 13485 certification body whose certificate supports a finished-device manufacturing or sterilization site, including contract sites. Retain the supporting accreditation evidence for that check. MDSAP certificates remain an alternative where they cover the site.

These guidances do not state a special rule for applications filed before 1 October 2026. For the September R14 changes to GN-15, see HSA GN-15 R14: Annex 4 and Registration Requirements. HSA also does not further define "Global ACI recognised accreditation bodies", so confirm the status of the specific accreditation body rather than relying on a mark alone.