Medical Device
Provision to submit Periodic Safety Update Reports(PSUR) w.r.t Marketing Authorization of Medical Devices/In-Vitro Device is now available on Medical Device Portal.
Note : For Medical devices which are under voluntary registrations , the file number generated is the registration number of firm.

About Us

The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the country.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.


Online Application Submission

Tracking of Applications

Workflow Enabled System

Timely Alerts & Notifications

Analytical & Statistical Platforms

Consumer Forms For Medical Devices

Portal Statistics