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:
- Nebulizers
- Blood pressure monitoring equipment
- Digital thermometers
- Glucometers
In addition, CDSCO will extend compliance deadlines for several types of imaging and other devices to April 1, 2021:
- Implantable devices
- CT scan equipment
- MRI equipment
- Defibrillators
- Dialysis systems
- PET equipment
- X-Ray machines
- Bone marrow cell separation devices
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.
Learn more about Indian medical device regulations at Emergo by UL:
- India CDSCO medical device registration consulting
- India Authorized Agent in-country representation
- Whitepaper: India’s Medical Device Rules, 2017
- Regulatory process chart: India medical device approval
Author
- Stewart Eisenhart