Government Authority (CDSCO) The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical de...
An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is...
The Fourth and Fifth Schedule Audits, conducted by either a Notified Body or the Central Licensing Authority (CLA), are essential...
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...
CDSCO - The Government Authority Medical device registration in India is overseen by the Central Drugs Standard Control Organisati...
Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is...
Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
Q: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelin...
The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...