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HSA GL-04

GL-04

Regulatory Guidelines for Software Medical Devices — A Life Cycle Approach
SingaporeHealth Sciences AuthoritySoftware/SaMD
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What this code is

GL-04 is the official HSA identifier for “Regulatory Guidelines for Software Medical Devices — A Life Cycle Approach”. GL-04 is the official identifier HSA uses for this instrument.

Instrument
GL-04
Full name
GL-04
Category
Software/SaMD
Source links
Authority source
English
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36 articles · 1 language version
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Dates
Published
December 2025
Effective
—
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English full text36 articles · English — official textRead HTML →
About this regulation

Regulatory Guidelines for Software Medical Devices — A Life Cycle Approach

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).

GL-04 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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