https://www.taxtmi.com/news?id=33560 The document explains WHO Prequalification for IVDs, limited to original manufacturers, and describes three assessment stages-Product Dossier Review, Laboratory Performance Evaluation, and Manufacturing Site Inspection-to verify conformity with ISO 13485:2016. It sets out two procedural routes: full assessment and abridged assessment based on prior regulatory decisions. The note identifies major barriers for Indian manufacturers, notably high costs, facility qualification challenges, and shortages of regulatory and quality personnel, and recommends government financial support and specialised consultancy assistance to enable global market access. en-us Tue, 11 Feb 2025 10:46:03 +0530 Tue, 11 Feb 2025 10:46:03 +0530 TaxTMI RSS Generator https://www.taxtmi.com/news?id=33560 The document explains WHO Prequalification for IVDs, limited to original manufacturers, and describes three assessment stages-Product Dossier Review, Laboratory Performance Evaluation, and Manufacturing Site Inspection-to verify conformity with ISO 13485:2016. It sets out two procedural routes: full assessment and abridged assessment based on prior regulatory decisions. The note identifies major barriers for Indian manufacturers, notably high costs, facility qualification challenges, and shortages of regulatory and quality personnel, and recommends government financial support and specialised consultancy assistance to enable global market access. News - Tue, 11 Feb 2025 10:46:03 +0530 https://www.taxtmi.com/news?id=33560