The full form of DCGI is Drugs Controller General of India.

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.[The government has announced its plan to bring all medical devices, including implants and contraceptives, under the view of the Central Drugs and Standard Control Organisation (CDSCO) But Some instruments, Equipments with IVD will not cover in Medical Device rule Such as hemoglobinometer based micro cuvette technology which is reagent free because Micro cuvette is under the category of plastic disposable which is only used for sample collection and this category is not regulated under the provision of Class II of IVD Medical device rules.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed. Manufacturers who deal with the authority are required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India

The Central Drugs Standard Control Organization is the Indian regulatory body for pharmaceuticals and medical devices, being the equivalent of the FDA in the US. The CDSCO is responsible for the regulating the manufacture, approval and sale of medical devices and drugs in India, for clinical trials as well as for providing expert advice on health issues and the enforcement of the Drugs and Cosmetics Act.

The department within the CDSCO responsible for regulating medical devices and drugs is known as the Drug Controller General of India (DCGI), in institution under the Indian Ministry of Health and Family Welfare. Inspections, audits, post-market surveillance and recalls are done through the department that is split into zonal offices.

Major Regulations

Some of the most important regulations for medical devices in India are:

• India Medical Device Rules 2017
• Clarification On Import And Manufacture Of Medical Devices
• Guidance Document on Common Submission Format for Registration of Medical Devices in India