May 28, 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.

The CDSCO notice  pertains to the following device types, all of which will be assigned moderate to moderate-high Class B and Class C risk classifications:

  • CT scan equipment (Class C)
  • MRI equipment (Class C)
  • Defibrillators (Class C)
  • Dialysis machines (Class C)
  • PET equipment (Class C)
  • X-ray machines (Class C)
  • Bone marrow cell separators (Class B)
  • Nebulizers (Class C)
  • Blood pressure monitoring devices (Class B)
  • Digital thermometers (Class B)
  • Glucometers (Class C IVD)
  • Organ preservation solutions (Class C)

These risk classifications will allow Indian medical device market registrants and their in-country representatives to get a better idea of issues such as cost, clinical data requirements (if any) and import licensing authority as they commercialize their products in India.

Additional Indian medical device regulatory resources from Emergo by UL: