How to Obtain CDSCO Approval for Medical Devices

Obtaining CDSCO (Central Drugs Standard Control Organization) approval in India is a crucial step for entering this growing market. The process starts with submitting a detailed application that includes the Intended Use of your product and provides evidence of safety and efficacy, including clinical data if required. It’s also essential to demonstrate that the product complies with Good Manufacturing Practices (GMP) to ensure quality.

The approval process consists of three stages: the application submission, the CDSCO’s review to assess safety and compliance, and the final decision, which may require additional information if necessary.

Obtaining approval is not just a requirement; it opens the door to one of the world’s largest healthcare markets, instilling trust among healthcare professionals and patients by demonstrating that your product meets high standards.

If the process seems complex, we are here to help ensure compliance and simplify your path to approval.

Contact us today to get started!