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...
Are you planning to enter the Indian MRI machine market? Are you unclear of the CDSCO regulations for MRI machine? Need guidance and support for securing the CDSCO license for MRI machines in India? Well, look no beyond. We have prepared this guide to help you sort...
The Indian medical device industry is strictly regulated. Medical device manufacturers or importers are required to comply with regulatory guidelines as well secure the necessary certificates and licenses. The regulatory approval pathways for medical devices are being...