20Mar Date March 20, 2024 Author AkshayaMedical Device Regulation in IndiaBy 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device ma...
15Feb Date February 15, 2024 Author Mr. Arunkumar ChokkalingamNEW IVDIn India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...
24Jan Date January 24, 2024 Author Mr. Arunkumar ChokkalingamWhat is UDI in the EU Context?Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...
16Nov Date November 16, 2023 Author Mr. Arunkumar ChokkalingamIntroduction to Technical Documentation under EU MDR 2017/745Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's co...
30Oct Date October 30, 2023 Author Mr. Arunkumar ChokkalingamWhat is EUDAMEDIt's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vi...