CURRENT AFFAIRS

Detailed explanation-1: -Medical device registration in India is overseen by the Central Drugs Standard Control Organization (CDSCO), under Directorate General of Health Services in the Ministry of Health & Family Welfare.

Detailed explanation-2: -Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare.

Detailed explanation-3: -The Notified Devices are the devices that are regulated under the Medical Devices Rules (MDR), 2017 by the CDSCO – the Health Agency in India that oversees the regulation of notified and non-notified medical devices.

Detailed explanation-4: -The National Medical Devices Policy 2022 lays down a clear roadmap for accelerated growth of the medical devices sector while promoting safety and quality to systematically achieve key principles & objectives of the National Health Policy 2017 viz. 4.2.

Detailed explanation-5: -In July 2021, the National Pharmaceutical Pricing Authority (Pricing Authority), through a notification (July 2021 notification) announced that it would regulate the prices of five medical devices: (i) pulse oximeter; (ii) blood pressure monitoring machine; (iii) nebuliser; (iv) digital thermometer; and (v) glucometer.