Singapore HSA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
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)