Medical device Archives

Medical device

CDSCO Notifies To Update The Product Insert Of 4th Generation HIV In-Vitro Diagnostics Kit

Posted by: admin April 22, 2021

CDSCO has designated the National Institute o

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22nd April, 2021

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Regulation/Guidelines

DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining To Anesthesiology

The Drugs and Cosmetics Act, 1940, and Rules regulate the safety, quality, and performance of all medical devices. The Central Government has notified Medical Devices Rules, 2017 vide G.S.R. 78E...

17th September, 2021

Regulation/Guidelines

Regulatory Updates on Disinfectants

Sanitizers can be of different variants, primarily based on active ingredients, such as soap containing natural fats, detergents, or alcohol-based (Table 1). The Centers for Disease Control and Prevention (CDC)...

11th August, 2021

Regulation/Guidelines

COVID-19 Home Testing Using Rapid Antigen Tests (RATs)

Rapid Antigen tests (RATs) are commonly used to diagnose respiratory pathogens, including influenza virus and SARS-CoV-2 virus. These tests have come to practical use in the diagnosis of the infection...

10th June, 2021

Regulation/Guidelines

CDSCO Provides Guidelines For Approval Of COVID-19 Vaccines For Restricted Use In An Emergency Situation In India And For The Import Of Vaccine By The Private Sector

Approval of COVID-19 vaccines for restricted use in India On the 15 th April, 2021, the National Expert Group on Vaccine Administration for the COVID-19 recommended the authorization for the...

2nd June, 2021