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...

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...

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...

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...

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...

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...

On 3rd September, 2020, CDSCO released a draft classification for non-notified Medical devices. The Ministry of Health and Family Welfare (MoHFW) is going to classify non-notified medical devices like gowns, adhesive drapes,...

Presently in India, only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules in 1945. The Central Drugs Standards Control Organization (CDSCO) streamlined the process...