Healthcare, Industry News, Medical Devices, Regulatory Affairs

CDSCO added eight medical device types to list of regulated devices

Central Drugs Standard Control Organization (CDSCO), Indiaexpands oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020. According to the new CDSCO notice, the following device types will require registration and import licensing under the Medical Device Rules, 2017:

  • All implantable medical devices
  • CT Scanning equipment
  • X-Ray equipment
  • MRI Equipment
  • Dialysis machines
  • Bone marrow cell separators
  • Defibrillators
  • PET equipment

Both new importers and domestic manufacturers as well as companies currently selling such devices in the country will have to register with CDSCO by the April 2020 deadline in order to continue legally marketing these device types.

Be the First to comment.

Leave a Comment

Your email address will not be published. Required fields are marked *