Standards for medical devices: Electroconvulsive therapy machine

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...

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Bibliographic Details
Published inAsian journal of psychiatry Vol. 93; p. 103938
Main Authors Gangadhar, Bangalore N., Sreeraj, Vanteemar S., Sinha, Preeti, Thirthalli, Jagadisha
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier B.V 01.03.2024
Subjects
Device
Electroconvulsive therapy
Legal regulation
Safety certification
Electroconvulsive therapy
Safety certification
Device
Legal regulation
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Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1876-2018
1876-2026
DOI:10.1016/j.ajp.2024.103938