Government Authority (CDSCO) The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical de...
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Dec
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...