Apr 27, 2021

The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017.

According to a recent CDCSO order, Notification S.O. 775(E) establishing regulation of the following medical devices will be delayed by six months:

  • Implantable medical devices
  • CT scan equipment
  • MRI equipment
  • Defibrillators
  • PET equipment
  • Dialysis machines
  • X-Ray machines
  • Bone marrow cell separator devices

Ensuring adequate CDSCO compliance preparation time for implantable medical devices

Implementation of regulatory requirements for these device types had been set for April 1, 2021, but CDSCO cites the need for additional time to prepare for compliance in order to complete procedural work such as audits of facilities, query resolutions and related issues.  As such, manufacturers and importers that have already submitted their applications to CDSCO may continue marketing their devices in India as they prepare for compliance.

Indian regulators first announced in late 2019 their plan to extend regulatory oversight to all medical devices, but then postponed compliance deadlines to 2021 for some products. Emergo by UL consultants in India will provide updates on the new October 2021 timeframe for implantable devices as they become available.

Learn more about Indian medical device regulations at Emergo by UL:

Author

  • Stewart Eisenhart

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