Singapore medical device regulations

HSA GN-15 Revision 13 (March 2026) product-registration guidance. Linked from the official HSA guidance-documents page. The previous default-source URL returned 404.

Prescribed-fee schedule for all Health Products Act regimes, ingested as the official informal consolidation in force from 1 July 2024 (incorporating S 833/2023). Regulations 1–5 (fees payable, time for payment, waiver or refund) plus all nine Schedules are in the corpus; the Sixth Schedule carries every medical-device fee as its own searchable item — registration application ($560), evaluation by class and process (e.g. Class B abridged $2,010, Class D full $12,000, drug-device combination full $75,600), annual retention ($39/$67/$134 by class), licence and variation fees.

Core medical-device subsidiary legislation made under sections 45, 71 and 72 of the Health Products Act, ingested as the official informal consolidation in force from 18 December 2023 (latest amendment S 809/2023). All 79 regulation blocks across Parts I–X are in the corpus — licensing (regs 2A–2B), licence exceptions (Part II), supply and wholesaling (Part III), emergency-use exception (Part IIIA), labelling and advertisements (Parts IV–V), registration and evaluation (Part VI, including the reg 26 evaluation processes and reg 26A cancellation-for-non-payment rule), export certification (Part VII), and duties of licensees/registrants (Part VIII) — with regulation 2 definitions split per term and the Third Schedule risk-classification criteria reproduced. Numbering gaps (no reg 50; the deleted stubs 27–29 and deleted Parts/Schedules) mirror the official consolidation.

Parent statute of Singapore health-product regulation, ingested as the 2020 Revised Edition served by Singapore Statutes Online (in operation since 31 December 2021, incorporating amendments to 5 December 2025 including the Statutes (Miscellaneous Amendments) Act 2025). All 75 sections across 14 Parts are in the corpus, with section 2 definitions split per term; the First Schedule carries the statutory definition of "medical device" (category 1). The 11 passage-specific fact URLs in the registry resolve onto stable section anchors in this document.

HSA guideline (July 2021, stating the current position as of 01 August 2022 in its conclusion) on additive-manufactured devices: categorisation of mass-produced versus custom-made and patient-matched devices with the in-line decision flowchart; regulatory controls by category (product registration including the Annex 2 for GN-17 list of configurations, the Table A basic dossier considerations for all 3D-printed devices, and dealer licensing with post-market obligations); plus IMDRF references. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 with annex-references, the Table A considerations kept as tabular text with repeated table headers, and sub-sections 3.1–3.4 as anchored blocks.

HSA guideline (June 2018) on the risk-based approach to devices intended for modification of appearance or anatomy: the Annex A positive list of high-risk products, the in-line categorisation decision flowchart, and the Table 2 safety concerns and documentary requirements per product (implants, fillers, and other listed devices) feeding product registration and dealer controls. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 with the multi-page Table 2 kept as tabular text including its repeated (continued) captions.

Dealer licensing requirements for importers, wholesalers, and manufacturers of medical devices in Singapore. License required before conducting business activities. The HSA site restructure removed the old /medical-devices/licensing path (now 404); the current licensing page lives under manufacturing-import-and-supply/dealers-licence and publishes no documents — the licensing GNs are linked from the guidance-documents collection.

HSA GL-04 Revision 4 (December 2025), the life-cycle guidelines for software medical devices and Software as a Medical Device, covering change notification to registered software, cybersecurity, machine learning-enabled devices, and the Change Management Programme. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-11 (References).

HSA GL-06 Revision 2 (October 2023) on classifying borderline products: medical-related-purpose products against First Schedule versions, general purpose products, assistive technology, sports/fitness, and PPE. Exact PDF from the official guidance-documents collection. Ingested as six banner sections with the product-by-product classification tables kept as tabular text.

HSA GL-07 Revision 2 (July 2025) applying the IMDRF risk categorization framework to SaMD and setting out when clinical decision support software is regulated. Exact PDF from the official guidance-documents collection. Ingested as four banner sections (Introduction, Classification, Clinical Decision Support Software, References) with the risk-classification matrix kept as tabular text.

HSA GL-08 Revision 2 (September 2025). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-3 plus Annex 1.

HSA GL-10 Revision 1 (August 2026). Exact PDF resolved from the official go.gov.sg/gl-10-r1-14-08-2026 collection shortlink. Ingested as sec-1 through sec-9.

HSA GL-17 Revision 4 (October 2025). E-submission guide for general medical device product registration in SHARE, for submissions based on the ASEAN CSDT or the IMDRF ToC; section 2 covers the SHARE application form and responses to input-request queries, and section 3 is the Table 1 summary of submission requirements. Exact PDF from the official guidance-documents collection; ingested as the printed cover plus sec-1 through sec-3.

HSA GL-18 Revision 4 (October 2025). E-submission guide for IVD medical device product registration in SHARE, for submissions based on the ASEAN CSDT or the IVD ToC; section 2 covers the SHARE application form and responses to input-request queries, and section 3 is the Table 1 summary of submission requirements. Exact PDF from the official guidance-documents collection; ingested as the printed cover plus sec-1 through sec-3.

HSA GN-02 Revision 8 (April 2026). Exact PDF resolved from the official go.gov.sg/gn02r8 collection shortlink. Ingested as sec-1 through sec-9 plus Annexes 1, 2, and 5. Annexes 3 and 4 are separate templates, not this PDF.

HSA GN-03 Revision 3 (June 2011). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 plus Annex 1.

HSA GN-04 Revision 2.2 (November 2017). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-3 plus Annexes 1–2.

HSA GN-05 Revision 3 (8 September 2023). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-9.

HSA GN-06 Revision 3 (November 2022). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-7.

HSA GN-07 Revision 3 (September 2023). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4.

HSA GN-08 Revision 2 (June 2018). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-7 plus Appendix A.

HSA GN-09 Revision 4 (July 2025). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-2 plus Annex 1.

HSA GN-10 Revision 4 (July 2025). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-14 plus Annex 1.

HSA GN-11 Revision 1.3 (November 2022). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-3 plus Annex 1.

HSA GN-12-1 Revision 3 (June 2026). Exact PDF resolved from the official go.gov.sg collection shortlink. Ingested as sec-1 through sec-3, including grouping categories sec-3-1 through sec-3-5.