TMDA TMDATMDA/DMD/MDA/G/001 Rev 03
TMDA/DMD/MDA/G/001 Rev 03 is the official TMDA identifier for “Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment”. TMDA/DMD/MDA/G/001 Rev 03 is the official identifier TMDA uses for this instrument.
- Instrument
- TMDA
- Full name
- TMDA/DMD/MDA/G/001 Rev 03
- Category
- Registration
- Authority source
- English
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- 0 articles · 1 language version
- Published
- June 2024
- Effective
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Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment
TMDA marketing-authorization compendium (June 2024, document # TMDA/DMD/MDA/G/001 Rev 03, 247 pages) — the official successor to the standalone "Guidelines on Submission of Documentation for Registration of Medical Devices" (TMDA/DMC/MDC/G/001, 3rd edition April 2020), whose stored TMDA upload URL now returns HTTP 404 while TMDA's marketing-authorization procedure page links this compendium alongside the dead file. Consolidates the dossier guideline family into Parts I-XI — procedural aspects for marketing authorization, technical documentation requirements for medical devices and IVDs, notification of exempted devices, classification rules for devices and IVDDs, clinical evidence, labelling incl. electronic IFU, grouping, software and AI medical devices, borderline products — plus Annex I essential-requirements checklist, Annex II essential-principles guidance, and Annex III ISO 15223-1 symbols. Ingested in full with all parts and annexes.
TMDA/DMD/MDA/G/001 Rev 03 is the official identifier TMDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.