Medical device manufacturers/importers who wish to conduct a clinical investigation in India need to obtain permission from the CLA. The CLA is the Central Licensing Authority (CLA) and functions under the CDSCO. The CDSCO is the Central Drugs Standard Control...
In this blog, we have focused on the differences between notified and non-notified medical devices in India. Additionally, we have provided an overview of the different regulatory processes for different categories of medical devices. Furthermore, we have touched upon...
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...
Are you planning to start a haemodialysis solution manufacturing business in India? Well, you have landed in the right place. We have curated this detailed guide just for you. Dialysis: A life saving treatment for patients with kidney failure or ESRD If you want to...
Medical device grouping has been introduced to enhance the license application process in India. Grouping of medical devices expedites and simplifies the CDSCO registration and license application process. In this blog, we will delve into the grouping of medical...