India Moves to Online Application Submission System for Medical Device Registration

The Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications). From April 1, 2016 hard copy submissions were no longer accepted by the CDSCO.

Then on May 9, the DCGI requested that any hard copy application submitted from December 1st, 2015 be re-submitted using the SUGAM system. It is not clear if these applications will lose their place in queue.

After early implementation issues are addressed, the system is expected to make the application submission and review process more efficient for medical and IVD devices.

Contact Asia Actual to register medical devices as India moves to an online system.