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 MoreRegulatory Update
November 10, 2021
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
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...
Blog
April 22, 2021
CDSCO has designated the National Institute of Biologicals (NIB), Noida, as Central Medical Device Testing Laboratory as per rule 19 of Medical Device Rules, 2017 released on 1st June 2018.NIB performs tests...
Blog
March 10, 2021
CDSCO has notified four medical devices, i.e., nebulizer, blood pressure monitoring devices, digital thermometer, and glucometer as drugs. The importers and manufacturers of these 4 medical devices need to take import and...
Blog
January 5, 2021
The Ministry of Health and Family Welfare has recently come up with a release of notification dated 21st October 2020 to extend the timeline from 1st day of November, 2020” to the...
Blog
November 9, 2020
The Central Drugs Standard Control Organisation (CDSCO) has released two notices on September 3, 2020, including the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs). To simplify the classification process...