LexamedAI @LexamedAI
AI-powered platform delivering country-wise medical and healthcare regulatory guidance for drugs, medical devices, and clinical research. lexamedai.com Joined January 2026-
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Before a medical device can be supplied in Australia, it must be listed in the ARTG by the Therapeutic Goods Administration. Steps: classify device → obtain conformity evidence → submit ARTG application → TGA review. Approval grants an ARTG number, allowing legal supply.
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🔬 TGA Device Classes I → Low risk IIa → Low–moderate IIb → Moderate–high III → High AIMD → Implantable IVDs: Class 1–4 by health risk. Class determines ARTG evidence. #LexamedAI #TGA #MedTech for more: lexamedai.com
🔬 Class IIa Medical Device Registration – Australia To supply a Class IIa device in Australia, it must be listed in the ARTG via the TGA. Key steps: • Confirm classification • Obtain conformity evidence (CE/FDA/MDL) • Appoint Australian sponsor • Submit via eBS portal
How does a prescription drug get approved in Australia? 🇦🇺 TGA pathway: • Pre-clinical + clinical trials (CTN/CTA) • CTD dossier submission • TGA review: quality, safety, efficacy • ARTG registration • Post-market monitoring Learn more lexamedai.com #TGA
How do you register a prescription medicine in Australia? It must be listed in the ARTG by the TGA. Steps: • Pre-submission meeting • CTD dossier submission • TGA review • ARTG listing (AUST R) More ↓ lexamedai.com #LexamedAI #MedTech #Regulatory
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