Pure Global AI
HSA GN-18

GN-18

Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT
SingaporeHealth Sciences AuthorityRegistration
Official source linked
What this code is

GN-18 is the official HSA identifier for “Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT”. GN-18 is the official identifier HSA uses for this instrument.

Instrument
GN-18
Full name
GN-18
Category
Registration
Source links
Authority source
English
Open the issuing-authority text
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
10 articles · 1 language version
Read the full text →
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
October 2025
Effective
—
Readable full text

Open a language version

Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

English full text10 articles · English — official textRead HTML →
About this regulation

Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT

HSA GN-18 Revision 4 (October 2025). IVD counterpart to GN-17 with the same October 2025 graphical layout, ingested through the page-aware CSDT parser. Ingested as sec-1, sec-2, Section 3, and Section 4.1–4.6 including 4.3.2 clinical evidence.

GN-18 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

Verified