Standards for medical devices: Electroconvulsive therapy machine

Abstract

The manuscript calls for establishing a standard for electroconvulsive devices by manufacturers for better regulation in India. This is most relevant in the context of two recent developments, (a) Notification of medical devices rules, 2017 with classification of ECT as Class C and (b) Recent change in classification of ECT devices by US-FDA in 2018. The establishment of standards would help in upregulating the standard of ECT devices as well as ECT practices.

Keywords: Device; Electroconvulsive therapy; Legal regulation; Safety certification.