The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
Purpose MD-26 is the application form used to seek permission from the Central Licensing Authority (CLA) to import or manufact...
Government Authority (CDSCO) The Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare...
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...