Singapore HSA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
HSA Updates GN-15-R14 Guidance on Medical Device Product Registration (Sep 2026)
2026-09-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA has published revision R14 of GN-15 Guidance on Medical Device Product Registration, dated 10 September 2026. The update applies to manufacturers, importers, and registrants responsible for medical device registration in Singapore. Affected stakeholders should review the revised guidance and adjust registration dossiers and submission processes to meet the updated HSA requirements.
Tags: singapore_hsa, medical_device_registration, guidance_update
HSA Publishes Summary of Responses to Public Consultation Feedback on Medical Device Cybersecurity Best Practices Guide
2026-08-14 | Singapore HSA | Regulation Update | !! MEDIUM
The Health Sciences Authority (HSA) has published a summary of responses to feedback received during the public consultation on its Best Practices Guide for Medical Device Cybersecurity. This item is relevant to medical device manufacturers, importers, and suppliers placing devices in Singapore, as it clarifies stakeholder comments and HSA's positions on cybersecurity expectations. Regulatory affairs professionals should review the responses and the final guide to ensure their medical device cybersecurity documentation and risk management align with HSA recommendations.
Tags: medical_device_cybersecurity, hsa, regulatory_guidance, public_consultation, singapore
HSA Updates GN-21 R7 Change Notification Guidance for Registered Medical Devices (Effective Jul 2026)
2026-08-01 | Singapore HSA | Regulation Update | !! MEDIUM
Singapore’s Health Sciences Authority (HSA) has issued revision 7 of Guidance Document GN-21 on change notification for registered medical devices. The updated guidance, effective 31 July 2026, clarifies when and how registrants must notify HSA of changes to their devices. Manufacturers and local representatives should review the revised criteria, update internal change management procedures, and ensure all post-market modifications are correctly reported to avoid non-compliance.
Tags: change_notification, guidance_document, medical_devices, HSA, Singapore
HSA Updates GL-10-R1 Best Practices Guide on Medical Device Cybersecurity
2026-08-01 | Singapore HSA | Regulation Update | !! MEDIUM
The Health Sciences Authority (HSA) has updated guidance document GL-10-R1, 'Best Practices Guide on Medical Device Cybersecurity.' The guide outlines cybersecurity regulatory expectations and best practices for medical device manufacturers, importers, and suppliers in Singapore. Affected stakeholders should review the updated guidance and align pre-market submissions, post-market risk management, and cybersecurity documentation with the latest recommendations.
Tags: medical_device_cybersecurity, hsa_guidance, regulatory_update
HSA Alert: 3 Consumers Including a Child Suffer Serious Adverse Events from Products with Banned/Potent Ingredients
2026-07-23 | Singapore HSA | Regulation Update | !!! HIGH
The Singapore Health Sciences Authority (HSA) issued a press release reporting three consumers, including a 12-year-old, who experienced serious adverse effects after taking products containing banned or potent undeclared medicinal ingredients. The alert warns the public against purchasing and consuming unapproved health products from unknown sources. HSA advises anyone who has taken such products to stop immediately and consult a doctor, and urges the reporting of any adverse events. Regulatory affairs professionals should note heightened enforcement against adulterated health products and review compliance of their own product vigilance systems.
Tags: hsa_alert, serious_adverse_events, banned_medicinal_ingredients, consumer_safety
HSA Updates GN-21-R7 Guidance on Change Notification for Registered Medical Devices (Jul 2026)
2026-07-01 | Singapore HSA | Regulation Update | !! MEDIUM
Singapore's Health Sciences Authority (HSA) has released revision 7 of the GN-21 guidance document on change notification requirements for registered medical devices, effective July 2026. This update impacts all medical device license holders who need to report changes to their registered devices. Companies must review the revised criteria for notifiable changes, update their internal procedures, and ensure compliance by the effective date to avoid regulatory findings.
Tags: change_notification, hsa_guidance, medical_devices, singapore, post_market_compliance
Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innova
2026-06-29 | Singapore HSA | Regulation Update | !! MEDIUM
HSA Speeches: Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innovation as a Catalyst for Global Medtech Growth" for Singapore Medical Device Ventu
GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes
2026-04-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes (2026 Apr)
GN-15-R13 Guidance on Medical Device Product Registration
2026-03-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-15-R13 Guidance on Medical Device Product Registration (2026 Mar)
GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach
2025-12-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2025 Dec)
GN-34 R2 Guidance for IVD Analysers
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-34 R2 Guidance for IVD Analysers (2025 Oct)
GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2025 Oct)
GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2025 Oct)
GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs)
2025-09-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2025 Sep)