IVD technology transfer is crucial for manufacturers transitioning IVDs from development to full-scale production or relocating manufacturing between facilities. A successful transfer demands meticulous planning, comprehensive documentation, and alignment with...
Given their important role in healthcare industry, in-vitro diagnostic devices (IVDs) have to be strictly regulated and monitored. CDSCO has formulated strict guidelines for IVDs in India. This apex regulatory body is aimed at enforcing these regulations to monitor...
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...
In this blog, we have curated a detailed guide for starting an IVD manufacturing plant in India. Additionally, we have discussed the necessary CDSCO license required for setting up an IVD manufacturing facility. What are IVDs? IVDs or in vitro diagnostic devices are...
In-vitro diagnostic devices are instruments, reagents, or systems intended to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes and similar equipment outside the body. Moreover, the tests can be performed using various...