CDSCO - The Government Authority Medical device registration in India is overseen by the Central Drugs Standard Control Organisati...
In the Indian medical device regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO), an "endorse...
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...
In the context of medical device licensing in India, a post-submission request refers to any communication or additional documenta...
India's burgeoning medical device market presents a lucrative opportunity for manufacturers worldwide. However, introducing innova...
Purpose MD-26 is the application form used to seek permission from the Central Licensing Authority (CLA) to import or manufact...
The Fourth and Fifth Schedule Audits, conducted by either a Notified Body or the Central Licensing Authority (CLA), are essential...
Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is...
In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...