Medical Device
October 25, 2023
Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...
Read MoreBlog
October 27, 2021
Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical...
Blog
October 11, 2021
The Central Drugs Standards Control Organization (CDSCO) has recently released a notification on 26th July 2021 for the classification of medical devices used in the Dermatological and Plastic Surgery under the provisions...
Blog
September 17, 2021
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 dated January...
Blog
August 11, 2021
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) recommends the...
Blog
June 10, 2021
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 in the...
Blog
June 2, 2021
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 emergency use...
Blog
May 31, 2021
As the situation arising out of the Covid-19 pandemic is worsening further in the country, the Drugs Controller General of India (DCGI) has further extended deadline by four months to submit notarized...
Blog
May 31, 2021
Regulations for the import or manufacture of medical devices The Ministry of Health & Family Welfare, Government of India, has notified the list of equipment or devices which will be regulated as...
“Video-Only” Resource For Ease Of Understanding