Gunjan Verma- India

“As anticipated the CDSCO responded to industry’s request to postpone the registration deadline for ultrasound equipment consistent with treatment of other newly notified devices.”
Gunjan Verma
Asia Actual India 

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Important Documents and Links

INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

Initially published on: October 22, 2019

Updated on: October 26, 2020

UPDATE: Deadline for the registration of Ultrasound scanners postponed by 12 months to November 1, 2021.  

India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India. As seen in previous Notifications, the CDSCO is expected to release guidance of risk classification and generic intended use for ultrasound equipment.

Manufacturers and importers of these devices will need to obtain an Import Licenses (Form MD-15) under the Medical Device Rules, 2017 to maintain market access. Products without valid license may not be imported and marketed after November 1, 2020 (UPDATED: November 1, 2021).

Suggested actions:

  • Identify any devices in your portfolio that utilize ultrasound technology
  • Confirm if the intended use matches those listed in the CDSCO guidance document (when available)
  • Prepare for application submission for applicable devices no later than January 1, 2020 to ensure licenses are in place by November 1, 2020 (UPDATED: November 1, 2021).

The mandate was published in the Gazette of India on October 16th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.The resolution to regulate ultrasound equipment was originally raised 21 months earlier at the February 12th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact Asia Actual with questions or service inquiries.

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