Medical Device Registration In India | CDSCO
What is CDSCO?
The CDSCO (Central Drugs Standard Control Organization) is the national regulatory body for pharmaceuticals and Medical Device Registration In India. It’s a licensing authority. It approves any new chemical entity (drug) which is to be imported to India. CDSCO serves an analogous role to the Food and Drug Administration of the United States the PMDA of Japan, European Medicines Agency of the European Union etc.
Knowlege of CDSCO is must, to know about regulatory requirements of the medical device registration in India. Every nation under its Ministry of Health will have a dedicated governing body to look after every aspect of pharmaceutics and medical devices.
Central Drugs Standard Control Organization’s is head quartered in New Delhi, Capital Of India.
Within CDSCO, Drug Controller General of India (DCGI) is the final authority and controls medical devices and pharmaceuticals. Drug Controller General of India is in charge of endorsement of licenses of particular categories of Drugs such as IV-Fluids, blood and blood products, Sera, Vaccines and all medical devices.
The DCGI in-turn is directed by the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB). It is further divided into zonal offices which handle pre-licensing and post-licensing inspections, pharmacovigilance/post-market surveillance, and recalls when required.
Keeping in view what CDSCO as a governing body can do in handling this vast country. The Central Government of India has established four zonal offices of the CDSCO at Chennai i.e. CDSCO Chennai, Mumbai i.e. CDSCO Mumbai, Ghaziabad i.e. CDSCO Ghaziabad, and Kolkata i.e. CDSCO Kolkata. The Zonal Offices work in close association with the State Drug Control Administration and aid them in guaranteeing unvarying enforcement of the Drug Act and other related legislations throughout in Indian Sub-continent.
With a growing population and a healthy growth rate, Indian economy is rapidly picking up. Healthcare companies from all sectors – drugs, medical devices, IVDs are looking to invest in the country and selling their products in India. Partnering with a professional consulting team for regulatory clearances in the Indian market is the first step for successful market entry. As this process can often be the first bottleneck a company must undergo to ensure the safety of products for the Indian market and regulatory clearance by the Indian government to allow sales.
CDSCO Roles & Responsibilities:
CDSCO Authority: Who is Who?
Directorate General of Health Services governs and controls CDSCO. DGHS reports to Ministry of Health and Family Welfare, Government of India. It has multiple zonal offices throughout India. CDSCO also works closely with Central Drug Laboratories to perform quality control tests.
To regulate imported drugs as authority, the CDSCO works with the Drugs Technical Advisory Board and the Drugs Consultative Committee. On the other hand, the Central Drugs Laboratory undertakes to test such drugs.
The central authorities are responsible for the approval of new drugs, clinical trials in the country. Laying down the standards for drugs, control on the quality of imported drugs, coordinating activities of State Drug Control Organizations and providing expert advice. To bring uniformity in the enforcement of the Drugs and Cosmetics Act. The state authorities, on the other hand, are concerned with the regulation of manufacture, sale and distribution of drugs licensing, drug testing laboratories, approving drug formulations for manufacture, carrying out pre- and post-licensing inspections, and overseeing the manufacturing process. This applies to drugs manufactured by respective state units and those marketed in the state. These authorities are formed under the Drug and Cosmetics Act 1940 and Rules 1945.
Class A will include low-risk devices such as thermometers and tongue depressors. Low- to moderate-risk devices such as hypodermic needles will fall under Class B. Class C will cover moderate-to high-risk devices such as lung ventilators and bone fixation plates; and high-risk devices heart valves and implantable defibrillators, for example, will comprise Class D. The regulatory procedures for medical devices will vary according to their class. In general, higher-risk devices will require more regulations and a more stringent conformity assessment process. The process of Medical Device Registration In India varies according to their class. The objective of the present study is to provide an overview of Regulatory guidelines for medical devices. These are importing, registering, licensing and clinical trials in India.
Click here for New CDSCO Notified List of Medical Devices PDF