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HSA GN-15 Revision 15: Premarket Submission Checklist Now Required, Incomplete Submissions Rejected (1 Oct 2026)

HSA updated its medical device guidance index on 30 September 2026. Three registration documents changed, all effective 1 October 2026:

GN-15 Revision 15: Guidance on Medical Device Product Registration
GN-17 Revision 5: Preparing a submission for general medical devices using the ASEAN CSDT
GN-18 Revision 5: Preparing a submission for IVD medical devices using the ASEAN CSDT

HSA also introduced a new Premarket Submission Checklist (MD-01 R1, 01 Oct 2026). The GN-15 change matters most to registrants preparing a submission now, because it changes what counts as a complete application.

GN-15 R15: the Premarket Submission Checklist is now requirement #1

In GN-15 R15's summary tables of submission requirements, the Premarket Submission Checklist is now the first documentary requirement for these evaluation routes:

Device class	Routes where the checklist is required	Not required
Class B	Full, Abridged	Immediate (IBR)
Class C and D	Full, Abridged, Expedited (ECR-1, ECR-2, EDR)	Immediate (ICR)

The checklist itself states that it is not applicable to applications under the Immediate route.

What HSA treats as an incomplete submission

The checklist's opening note is direct. Do not submit if any required document is unavailable: incomplete submissions will be rejected and fees paid will not be refunded. HSA lists the following as incomplete (the list is non-exhaustive):

The Premarket Submission Checklist is not submitted with the application
The checklist is submitted but not completed, or only partially filled in
Required SHARE folders are empty, with no documents uploaded for applicable sections
The Annex 2 List of Configurations does not tally with the information in SHARE (for example identifiers or number of models)
The Annex 2 List of Configurations file mapping is not submitted for an entire implant system, including accessories
Documents are uploaded to the wrong SHARE folder (for example, a sterilisation report in the Biocompatibility folder)
Documents are uploaded to Section 13 (Others) when an appropriate SHARE folder exists
Placeholder documents are uploaded to indicate later submission (for example, a file saying "to be provided later", or a blank file)
SHARE folders for Section 8 are empty, with no justification given in the checklist

For any Section 8 item you consider not applicable, the checklist requires a reason. For example, if no biocompatibility document is provided, you must explain why, such as that the device is not patient-contacting.

ISO 13485 certification bodies

GN-15 R15 adds a note to its submission-requirement tables, and GN-17 R5 and GN-18 R5 carry the same wording. Certification bodies for ISO 13485 must either be accredited by Global ACI recognised accreditation bodies or be EU MDR/IVDR Notified Bodies. If your manufacturing-site certificates come from a certification body that meets neither condition, resolve it before you file.

GN-17 and GN-18 Revision 5

Both CSDT guidance documents moved from Revision 4 (21 Oct 2025) to Revision 5 (01 Oct 2026). The revision markers show two changes:

HSA continues to accept the IMDRF Table of Contents format as an alternative to the ASEAN CSDT. It now refers to it by its current name: the Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC) in GN-17, and the In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC) in GN-18.
The ISO 13485 certification-body wording above.

The shared Annex 2 List of Configurations template for GN-17 and GN-18 was also re-issued as an October 2026 version. Use the current template.

What to check before your next filing

Download the October 2026 Premarket Submission Checklist and complete every applicable line. A partially filled checklist counts as an incomplete submission.
Map every document to its correct SHARE folder, and remove any placeholders.
Reconcile the Annex 2 List of Configurations against what you enter in SHARE: identifiers, model count, and full implant systems including accessories.
Confirm that your ISO 13485 certification bodies meet the R15 accreditation condition.
Use the October 2026 versions of the GN-15 annex templates (Annexes 1–4) and the Annex 2 List of Configurations.

Sources

HSA guidance documents index (last updated 30 September 2026): HSA Medical Device Guidance Documents
GN-15-R15 Guidance on Medical Device Product Registration (2026 Oct): go.gov.sg/gn-15-r15-30-09-2026 (PDF, HSA)
Premarket Submission Checklist MD-01 R1 (2026 Oct): go.gov.sg/premarketsubmissionchecklist-2026oct (PDF, HSA)
GN-17 R5 (2026 Oct): go.gov.sg/gn-17-r5-30-09-2026 (PDF, HSA)
GN-18 R5 (2026 Oct): go.gov.sg/gn-18-r5-30-09-2026 (PDF, HSA)

Related regMD coverage

This article summarises publicly available HSA guidance for informational purposes and does not substitute for legal or regulatory advice. Always refer to the primary HSA documents and consult your Regulatory Affairs adviser before filing.