When there is a new technology implemented, or new material used for the device manufacturing, or mentions any new indication for use, the manufacturer has to confirm the safety and performance of the device. For this purpose, the manufacturer needs to manufacture a small number of devices for the evaluation.
When you want to import a medical device to India and not aware of its characteristics, or you want to demonstrate its performance or provide training to healthcare professionals. You need a test license to import a small number of devices from their origin, as per the requirements.
We offer our expertise to secure a test license for a manufacturer or importer based on the organization’s requirements.