In the Indian medical device regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO), an "endorse...
Incomplete or Inaccurate Information: Missing Documents: Not including all the required documents as per the CDSCO guidelines...
What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...
Class A non-sterile non-measuring medical devices - Final notification GSR 777(E) was released by the Indian Ministry of Health an...
Understanding ISO 13485 and Notified Bodies ISO 13485:2016: The internationally recognized standard for quality management sys...
By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device ma...
In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...
Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...