CDSCO
Central Drugs Standard Control Organization
Classification
As per Indian MDR, the medical devices are classified based on the risk, and this risk is decided on basis of the intended use. The process of obtaining a manufacturing license is dependent on the device classification.
Test License
It is the first step in the process of registering your medical device in India. When a device with new technology, or new material, or any new indication of use; is to be placed on the market, the manufacturer must obtain a test license to manufacture a small number of devices to prove its safety and performance
Manufacturing License
Medical Device Manufacturers are required to obtain a manufacturing license from CDSCO for manufacturing, sale, or distribution of all classes of a medical device.
Import License
As per the Indian MDR, all the medical devices and IVD manufacturers located outside India who want to sell their devices in the Indian market should have an import license.
Post Approval Changes
In the life-cycle of medical devices, post-approval changes are important and are part of it. The organization may require this after they have got approval for manufacture or import due to various reasons.
Device Master File
Device Master File means a detailed information concerning the product which is to be submitted to relevant regulatory authority made in accordance with applicable rules and regulation.
We Provide end-to-end services by establishing and implementing a quality management system, classifying your devices, getting test license and manufacturing license, submitting the application on Sugam portal, providing audit support, and responding to the queries.