27 Sep Date September 27, 2024 Author Ms. Sneha Ramasamy Navigating the Regulatory Landscape for Innovative Medical Devices Without a Predicate in India: A Comprehensive Guide India's burgeoning medical device market presents a lucrative opportunity for manufacturers worldwide. However, introducing innova...
22 Sep Date September 22, 2024 Author Akshaya Class C and D notified medical device manufacturing registration in India CDSCO - The Government Authority Medical device registration in India is overseen by the Central Drugs Standard Control Organisati...
17 Sep Date September 17, 2024 Author Aishwarya Technical Documentation under EU MDR 2017_745 Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is...
10 Sep Date September 10, 2024 Author Mr. Arunkumar Chokkalingam The EU In Vitro Diagnostic Regulation Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...