India to Require Ultrasound and Imaging Equipment to be Registered with the CDSCO

At the February 12th Drugs Technical Advisory Board (DTAB) meeting, a resolution was approved to add “ultrasound equipments and similar imaging equipments” to the list of notified notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. Organ preservation solution was also added to the list of notified devices.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official.   The last devices to go through this process, ablation devices, took 5 months from board resolution to Notification with a 6-month grace period for compliance.

Important guidance on specific devices to be included as well as classification confirmation are not yet available. Any manufacturers of medical devices including ultrasound technology, or medical imaging equipment in general should stay alert for updates and have plans for eventual registration.

This is the first Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. Industry is watching closely for patterns useful to predict future device additions.  Many more are expected in the coming  months.

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