CDSCO

The Authorised Indian Representative (AIR) is a legally recognised entity appointed by a foreign medical device manufacturer to represent it before the Central Drugs Standard Control Organisation (CDSCO) in India.…

The Central Drug Standard Control Organisation (CDSCO) port enforcement is the mechanism in coordination with the Central Board of Indirect Taxes and Customs to ensure that medical devices entering India…

The Central Drugs Standard Control Organisation (CDSCO) import licence process is the formal regulatory pathway by which a foreign medical device manufacturer and its Indian importer obtain legal authorisation to…

The Medical Devices Rules, 2017, operative from 1st January 2018, establish a four-tier, risk-based classification system for all medical devices regulated in India by the Central Drugs Standard Control Organisation…

The Drugs and Cosmetics Act, 1940 is the foundational statute governing the import, manufacture, distribution and sale of drugs and medical devices in India. The Central Drugs Standard Control Organisation…

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority for drugs, medical devices, diagnostics and cosmetics in India that operates under the Ministry of Health and Family…

Under the Medical Devices Rules, 2017, operative from 1st January 2018 and issued under the authority of the Drugs and Cosmetics Act, 1940, every medical device imported into India must…