Mandatory Documents Required for CDSCO Approval

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for medical devices and pharmaceuticals. Governed by the Drugs and Cosmetics Act, 1940, and Medical Devices Rules (MDR), 2017, CDSCO Certification, ensures that all medical devices being manufactured, imported, or sold in India meet the required standards of safety, quality, and effectiveness. One of the most important aspects of obtaining CDSCO approval is documentation. Whether you are a manufacturer or importer, submitting the correct documents is mandatory to secure approval for medical devices. Incomplete or incorrect documentation can lead to delays, rejection, or even penalties. This guide explains in detail the mandatory documents required for CDSCO approval, along with why they matter, the process to prepare them, and how EVTL India can help you navigate the compliance journey smoothly.