Jan 8, 2020
India’s medical device and pharmaceutical regulator, the Central Drugs Standard Control Organization (CDSCO), has issued an extension for several types of medical devices to register for market authorization.
The CDSCO extension means that the following device types, originally expected to register under India’s Medical Device Rules, 2017 by January 1, 2020, now have a January 2021 registration deadline:
In addition, CDSCO will extend compliance deadlines for several types of imaging and other devices to April 1, 2021:
As previously reported by Emergo by UL, Indian regulators had initially set a December 2019/January 2020 deadline for registration of these devices. The extension by CDSCO provides manufactures of such devices more time to prepare and ensure for compliance and maintain commercialization in India.
CDSCO registration for all medical device types would take effect December 1, 2019
India CDSCO rolls out medical device, IVD regulatory changes for October 2019
The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.