Regulation and Classification of Class A (Self Notified) Medical Devices

Regulation and Classification of Class A (Self Notified) Medical Devices

Indian regulatory process for Class A self-notified medical devices explained.

Introduction: This article focuses on the classification and regulation of Class A (Self Notified) medical devices under the Medical Device Rules 2017 in India. The Central Drugs Standard Control Organization (CDSCO) has outlined specific guidelines for medical devices, including those categorized as Class A, which are considered low risk and classified as Self Notified. While […]

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