Guidance documents for medical devices

Product Registration

Product Registration Guidelines

• GN-15-R13 Guidance on Medical Device Product Registration (2026 Mar) PUB ↗ (opens in new tab)

  • GN-15-R13 ANNEX 1 Letter of Authorisation Template (2026 Mar) ↗ (opens in new tab)

  • GN-15-R13 ANNEX 2 Marketing History Declaration Template (2026 Mar) ↗ (opens in new tab)

  • GN-15-R13 ANNEX 3 Safety Declaration Template (2026 Mar) ↗ (opens in new tab)

Unique Device Identification (UDI) Submission Guidelines

• GN-36-R2 Guidance on Medical Device UDI System (2022 July) PUB [PDF, 2.25 MB] ↗ (opens in new tab)

  • FAQ (Medical Device UDI System)_Updated 18 July 2022 [PDF, 481 KB] ↗ (opens in new tab)

  • UDI-DI Submission video for Registered Medical Devices ↗ (opens in new tab)

IVD Analysers

• GN-34 R2 Guidance for IVD Analysers (2025 Oct) PUB [PDF, 417 KB] ↗ (opens in new tab)

  • Annex 2 to GN-34 (2025 Oct) [XLS, 17 KB] ↗ (opens in new tab)

Medical Devices Product Classification

• GL-06-R2 Medical Devices Product Classification Guide (2023 Oct) PUB [PDF, 2.08 MB] ↗ (opens in new tab)

Product Specific Regulatory Guidelines

• Telehealth Products R2.1 [PDF, 1.23 MB] ↗ (opens in new tab)

  • FAQ Telehealth Products R2.0 [PDF, 402 KB] ↗ (opens in new tab)

• Aesthetic-Related Guidelines_2018 [PDF, 462 KB] ↗ (opens in new tab)

• NGS (IVDs) [PDF, 589 KB] ↗ (opens in new tab)

• GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2025 Dec) PUB [PDF, 1.03 MB] ↗ (opens in new tab)

• GL-07-R2 Guidelines Risk Classification SAMD-CDSS (2025 Jul) PUB [PDF, 392 KB] ↗ (opens in new tab)

• Regulatory Guideline For 3D-Printed Medical Devices [PDF, 602 KB] ↗ (opens in new tab)

  • FAQ (3DP Medical Devices) 2021 [PDF, 805 KB] ↗ (opens in new tab)

• GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2025 Sep) PUB [PDF, 293 KB] ↗ (opens in new tab)

  • GL-08-R2 Annex 1 LDT Objective checklist Template (2025 Sep) ↗ (opens in new tab)

• GL-10-R1 Best Practices Guide on Medical Device Cybersecurity (2026 Aug) PUB ↗ (opens in new tab)

Product Registration Dossier Requirements

• GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2025 Oct) PUB [PDF, 1.47 MB] ↗ (opens in new tab)

  • E-Submission Guide for GMD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R4 (2025 OCT) PUB [PDF, 398 KB] ↗ (opens in new tab)

  • Annex 2 for GN-17 and GN18 List of Configurations (2025 Oct) [XLS, 50 KB] ↗ (opens in new tab)

• GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2025 Oct) PUB [PDF, 1.39 MB] ↗ (opens in new tab)

  • E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions R4 (2025 OCT) PUB [PDF, 424 KB] ↗ (opens in new tab)

  • Annex 2 for GN-17 and GN18 List of Configurations (2025 Oct) [XLS, 50 KB] ↗ (opens in new tab)

Medical Devices Risk Classification

• GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (18Sep-pub) [PDF, 756 KB] ↗ (opens in new tab)

• GN-14-R3 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (updated on 24 July 2023) [PDF, 321 KB] ↗ (opens in new tab)

Grouping of Medical Devices

• GN-12-1-R3 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on June 2026) ↗ (opens in new tab)

• GN-12-2-R2 Guidance on Grouping-Specific (2022 Jan) PUB [PDF, 447 KB] ↗ (opens in new tab)

Labelling of Medical Devices

• GN-23-R2 Guidance on Labelling for Medical Devices(2022 Sep) PUB [PDF, 293 KB] ↗ (opens in new tab)

Clinical Evaluation

• GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB [PDF, 444 KB] ↗ (opens in new tab)

Declaration of Conformity

• GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB [PDF, 267 KB] ↗ (opens in new tab)

  • GN-11 Declaration of Conformity Template(2022 Nov) ↗ (opens in new tab)

Essential Principles for Safety and Performance

• GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB [PDF, 332 KB] ↗ (opens in new tab)

  • Annex 2 GN-16 R4 Essential Principles Checklist Template (June 2018 version)172 KB ↗ (opens in new tab)

  • Annex 3 GN-16 R4 Essential Principles Checklist Template (Dec 2017 version)128 KB ↗ (opens in new tab)

Change Management program

• GN-37-R1 Guidance on Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD [PDF, 294 KB] ↗ (opens in new tab)

Dealer's licensing

Manufacturers, Importers and Wholesalers Licensing

• GN-02-R8 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2026 Apr) PUB ↗ (opens in new tab)

  • GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes (2026 Apr) ↗ (opens in new tab)

  • GN-02-R8 Annex 5 Declaration of Conformity to a QMS (2026 Apr) ↗ (opens in new tab)

Documents for Licensing

• GN-03-R3 Guidance on Preparation of a Site Master File for Licensing [PDF, 72 KB] ↗ (opens in new tab)

  • SMF Example for GN-03 Guidance on Preparation of a Site Master File for Licensing [PDF, 85 KB] ↗ (opens in new tab)

Class A Medical Devices

• GN-22 R8 Guidance for Dealers on Class A Medical Devices (Jul 2025) PUB [PDF, 298 KB] ↗ (opens in new tab)

Good Distribution Practice for Medical Devices (GDPMDS)

• GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB [PDF, 465 KB] ↗ (opens in new tab)

• GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB [PDF, 246 KB] ↗ (opens in new tab)

Change Notification and Amendments

Change of Registered Medical Device

• GN-21-R7 Guidance on Change Notification for Registered MD (2026 Jul) PUB ↗ (opens in new tab)

  • Annex 2 to GN-21 R7 Guidance on Change Notification for Registered MD (2026 Aug) ↗ (opens in new tab)

Change of Registrant

• GN-24-R2 Guidance on the Change of Registrant (2025 Jul) PUB [PDF, 302 KB] ↗ (opens in new tab)

  • ANNEX 1 GN-24-R2 Letter of Request Template (2025 Jul) ↗ (opens in new tab)

  • ANNEX 2 GN-24-R2 Relinquishing Company Form (2025 Jul) ↗ (opens in new tab)

Cancellation of Medical Device

• GN-25-R1 Guidance on the Cancellation of Medical Device Listing [PDF, 328 KB] ↗ (opens in new tab)

Special Access Routes

• GN-35-R5 Guidance on Special Access Routes (2025 Sep) PUB [PDF, 2.91 MB] ↗ (opens in new tab)

  • SAR Device List [XLS, 55 KB] ↗ (opens in new tab)

  • Request form for unregistered medical device for use on patients by QP and Licensed HCF(2025 Sep) [PDF, 1.88 MB] ↗ (opens in new tab) by qualified practitioner and healthcare facility (for GN-26 and GN-27 application)

  • MOH CLINICAL JUSTIFICATION REVIEW FORM FOR CLASS D MEDICAL DEVICE ↗ (opens in new tab)

  • GN-30 Product Owner Authorisation Template (2025 Sep) ↗ (opens in new tab) from product owner (for GN-30 application)

• SAR webinar slides_24mar22 [PDF, 617 KB] ↗ (opens in new tab)

Import of Unregistered Medical Devices for Exhibition

• GN-32-R6 Guidance for Importation of Unregistered MD for Exhibition (2025 Jul) PUB [PDF, 288 KB] ↗ (opens in new tab)

Custom-made Medical Devices

• List of Custom-made Medical Devices_August 2014 [XLS, 13 KB] ↗ (opens in new tab)

Advertisement and Sales Promotion

• GN-08-R2 Guidance on Medical Device Advertisements and Sales Promotion [PDF, 216 KB] ↗ (opens in new tab)

• Guidance for HCSA Licensees and Telemedicine Service Providers on Advertisement Controls of Health Products [PDF, 307 KB] ↗ (opens in new tab)

  • FAQs on Guidance for HCSA Licensees and Telemedicine Service Providers on Advertisement Controls of Health Products [PDF, 238 KB] ↗ (opens in new tab)

Safety Monitoring

Adverse Events Reporting

• GN-05-R3 Guidance on the Reporting of Adverse Events (2023 Sep) PUB [PDF, 275 KB] ↗ (opens in new tab)

Field Safety Corrective Action (FSCA)

• GN-10-R4 Guidance on Medical Device Field Safety Corrective Action (2025 Jul) PUB [PDF, 432 KB] ↗ (opens in new tab)

  • GN-10-R4 Annex 1 (2025 Jul) ↗ (opens in new tab)

Recall of Medical Devices

• GN-04-R2.2 Guidance on Medical Device Recall [PDF, 340 KB] ↗ (opens in new tab)

Complaint Handling

• GN-07-R3 Guidance on Complaint Handling (2023 Sep) PUB [PDF, 238 KB] ↗ (opens in new tab)

Dear Healthcare Professional Letter (DHCPL)

• GN-09-R4 Guidance on the Component Elements of a DHCPL (2025 Jul) PUB [PDF, 253 KB] ↗ (opens in new tab)

  • GN-09 R4 Annex 1 (2025 Jul) ↗ (opens in new tab)

Technical Reference Documents

• TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB [PDF, 341 KB] ↗ (opens in new tab)

• TR-02 R3 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB [PDF, 383 KB] ↗ (opens in new tab)

Archived Regulatory Guidances