Change Management

The CDSCO is very strict in distinguishing product specifications. Any difference or change in the product could cause a new classification and/or different CDSCO approval application requirements.

Specifically, inventions or developments that are new to the Indian market are subject to intense scrutiny. Additional tests or even clinical trials in India, which need to be applied for separately by both the manufacturer and importer, can be requested for the CDSCO certification, or the manufacturer and his AIR may be called to give a technical presentation before the CDSCO for further clarification.

We would be happy to check if your product classifies as new and mandatory for change approval, or if a simple CDSCO registration might suffice.

For more information regarding the CDSCO certification, please read our free information booklet “CDSCO Registration – The Booklet“.