Scheme Aimed at Promoting Domestic Medical Device Industry

by Sudhriti M | Sep 6, 2024 | Medical Device

The Indian government is aiming to make the domestic medical device industry self-reliant in the long run. Hence, it has rolled out various schemes to strengthen the medical device industry in India. These schemes align with the India’s vision of becoming a global...

Circular on Testing and Evaluation of Medical Devices and IVDs

by Sudhriti M | Sep 6, 2024 | Medical Device

Rigorous testing and evaluation of medical devices and IVDs is necessary to protect the public health. Medical devices and IVDs have a pivotal role in diagnosis and treatment of diseases and various medical conditions. Hence, regulatory officials have to ensure only...

License For Conducting Clinical Investigation in India: A Guide

by Sudhriti M | Sep 6, 2024 | Medical Device

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...

Notified and Non-Notified Medical Devices: Key Differences

by Sudhriti M | Aug 24, 2024 | Medical Device

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...

CDSCO IVD Classification: Everything You Need to Know

by Sudhriti M | Aug 19, 2024 | Medical Device

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...