February 14, 2020

India’s 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

The extension by CDSCO provides manufactures of such devices more time to prepare and ensure for compliance and maintain commercialization in India.

1) Gazette Notification S.O. 4671 (E) dated 27 December 2019

2) Gazette Notification S.O. 4672 (E) dated 27 December 2019

India; Extension of Deadline; MDR 2017