FDAnews Device Daily Bulletin

Concerns over who will take over as the Drug Controller General of India (DCGI) in mid-May are leading some industry observers to worry about another backlog in medical device import licenses and registrations. Prior to G. N. Singh’s three-month appointment as DCGI in February, a backlog of product import licenses and registrations persisted over two to three weeks while India’s Central Drugs Standard Control Organization remained without a leader authorized to sign regulatory documents, Abby Pratt, associate vice president of global strategy and analysis at AdvaMed, told IMDRM.
International Medical Device Regulatory Monitor