With increase in prevalence of cancer in India, the demand for oncology medical devices is increasing. To manufacture or import oncology medical devices, you need to secure the CDSCO medical device license. We have curated this guide to help you secure the CDSCO...
Nephrology focuses on kidney health and prevention, diagnosis, and treatment of kidney disease. Nephrologists specialize in the medical management of kidney diseases. Most kidney diseases result from the inability of the kidneys to properly filter waste products...
Cardiovascular medical devices are vital for the diagnosis and treatment of cardiovascular diseases. Given their vital role in the healthcare industry, they have to be stringently regulated. Hence, CDSCO, the apex medical device regulatory body, has formulated...
The US FDA 510(k) database is a centralized repository of all US FDA 510(k) submissions, clearances, and approvals. Hence, medical device manufacturers are required to refer to the US FDA 510(k) database preparing for FDA 510(k) clearance. Information from the...
Breathalysers are in high demand in India. Hence, manufacturing or importing breathalyser is a lucrative business opportunity for medical device companies. To ensure poor quality and ineffective products do not reach the Indian market, CDSCO has formulated stringent...
Owing to high demand for X-ray machines in India, the Indian government has chalked out stringent regulations for them. Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices. CDSCO regulations for X-ray machines are in...