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cdsco.gov.in and www.cdscoonline.gov.in The Central Drugs Standard Control Organisation ( CDSCO ) is India 's national regulatory body for cosmetics , pharmaceuticals and medical devices . It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation) With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
"Drugs and Cosmetics Rules, 1945" (PDF). Central Drugs Standard Control Organization.Archived from the original (PDF) on 31 October 2005.; A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context Recommendations for Drugs & Cosmetics Rules with context of Drug Schedules
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
This developing system of international mutual recognition agreements between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed test data accompanying exported goods to be readily accepted on overseas markets amongst the countries which have already qualified as significant to ...
1.18 18. FIEO – Federation of Indian Export Organisation ... CDSCO – Central Drugs Standard Control Organisation. 1.27 27. IBBI - Insolvency and Bankruptcy Board ...