India – India to Treat Implants and Imaging Equipment as Drugs From April 2020

India is pushing ahead with previously discussed plans to categorize certain classes of medical device as drugs. The change will mean implants and imaging equipment are subject to more burdensome regulatory requirements than in the past.

The Drugs Technical Advisory Board (DTAB) floated the idea of reclassifying “high end equipment” last year, leading the Drug Controller General of India (DCGI) Dr. Eswara Reddy to seek the industry’s feedback on the idea. Seven months later, India has committed to reclassifying the devices in April 2020.

The list of devices affected by the reclassification is unchanged from that released by DCGI in June, and only slightly different from the original DTAB proposal. That means the following devices will be regulated under drug rules…