India’s CDSCO Plans to Regulate Additional Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Indian regulators intend to expand oversight to additional types of medical devices.
- The Indian CDSCO has identified ultrasound and related imaging equipment as additions to its List of Notified Medical Devices.
- CDSCO has not provided any timeframes for when these products will become regulated devices.
India’s Central Drugs Standard Control Organization (CDSCO) plans to expand oversight to additional types of medical devices beyond those already regulated in the country.
During a February 2018 meeting of the Drugs Technical Advisory Board in New Delhi attended by Emergo consultants, CDSCO officials discussed their intention to expand the purview of the Drugs and Cosmetics Act, 1940 to cover devices including ultrasound and related imaging equipment as well as organ preservation solutions.
Affected devices will be added to the CDSCO List of Notified Medical Devices, but the agency has not yet indicated when regulation of these products will begin. Emergo consultants in New Delhi will provide additional updates as information becomes available.
Related Indian medical device regulatory information from Emergo:
- India CDSCO medical device registration consulting
- India Authorized Agent in-country representation
- Certificate of Free Sale (CFS) support for medical device exporters