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.

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