HSA GL-18GL-18
GL-18 is the official HSA identifier for “E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in SHARE”. GL-18 is the official identifier HSA uses for this instrument.
- Instrument
- GL-18
- Full name
- GL-18
- Category
- Registration
- Authority source
- English
- Readable HTML
- 11 articles · 1 language version
- Published
- October 2025
- Effective
- —
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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.
E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in SHARE
HSA GL-18 Revision 4 (October 2025). E-submission guide for IVD medical device product registration in SHARE, for submissions based on the ASEAN CSDT or the IVD ToC; section 2 covers the SHARE application form and responses to input-request queries, and section 3 is the Table 1 summary of submission requirements. Exact PDF from the official guidance-documents collection; ingested as the printed cover plus sec-1 through sec-3.
GL-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.