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Latest Additions to India CDSCO List of Regulated Medical Devices Include Implantables, CT Scanners

Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Eight medical device types added to India CDSCO list of regulated devices;
  • Latest batch of devices include implantable devices, CT scanners and MRI equipment;
  • These devices will have to be registered with CDSCO by April 1, 2020.

India’s Central Drugs Standard Control Organization (CDSCO) continues expanding oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020.

According to a new CDSCO notice, the following devices 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 Indian market entrants 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 products.

Most recently, CDSCO identified four other device types including nebulizers and digital thermometers that will fall under the Medical Device Regulations, 2017 starting in January 2020.

Additional Indian medical device regulatory information from Emergo by UL:

  • CDSCO medical device registration consulting
  • Certificate of Free Sale (CFS) service for medical device exports
  • Whitepaper: India’s Medical Device Rules, 2017 overview
  • Regulatory process chart: India’s device registration pathway

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