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India Adds Four Medical Device Types to CDSCO List of Regulated Products

Regulatory Updates | Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • India’s CDSCO has expanded its list of medical devices to be regulated.
  • CDSCO’s latest round of additions includes blood pressure monitors, digital thermometers and nebulizers.
  • Identified devices will have to comply with India’s Medical Device Rules 2017 starting January 1, 2020.

The Indian government will expand regulatory oversight to four additional types of medical devices starting in January 2020.

According to The Gazette of India and Emergo by UL consultants in , the four device types to be regulated by the Central Drugs Standard Control Organization (CDSCO) include nebulizers, blood pressure monitoring devices, digital thermometers and glucometers. Manufacturers of such devices commercialized in India will have to meet CDSCO regulatory requirements starting January 1, 2020.

This latest round of additions marks the third time in 2018 that CDSCO has expanded the number of medical devices it regulates under the Medical Device Rules 2017. Emergo by UL will report on other device types CDSCO adds to its list of regulated products as we learn them.

Related Indian medical device regulatory resources from Emergo by UL:

  • India CDSCO medical device registration and approval consulting
  • Medical device classification consulting
  • Certificate of Free Sale (CFS) support for medical device exports
  • Whitepaper: India Medical Device Rules 2017 overview
  • Regulatory process chart: India approval process for medical devices

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