Oct 22, 2014
The Indian Drugs Controller General’s office has launched a new task force to review processes and procedures currently in place at the Central Drugs Standards Control Organization (CDSCO) in order to boost efficiencies in how medical devices and drugs are reviewed and approved for sale in the country.
The task force includes former regional CDSCO officials as well as industry representatives, and is charged with recommending shorter, more user-friendly processes, procedures and forms. The task force will have two months to complete its review, and will then submit recommendations to the Drugs Controller General.
Any specific recommendations for medical device registration and approval processes in India will be reported and analyzed following conclusion of the task force’s work.
India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes:
The Drug Controller General (India) (DCGI) has announced plans to prescreen registration applications for medical devices and pharmaceutical products upon receipt beginning December 1, 2011.