Medical device product registration in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The Drugs Controller General of India (DCGI) under the CDSCO is responsible for the license or approval of all notified medical products.
In the past, manufacturers in India could sell any medical device as no jurisdiction existed for their regulations, but that is not the case today. In 2006, the Indian authorities made CDSCO registration mandatory for medical device products, i.e., registration of medical devices entering India to be compliant with the new Indian Medical Device Regulation to be overseen by the CDSCO (Indian FDA). And in 2017, Indian authorities brought massive changes to the medical device regulatory process with the publication of The Medical Device Rules. The rules came into force in January 2018 as the new legal framework for the regulation of medical devices and IVD devices by the Central Drugs Standard Control Organization (CDSCO).
The new framework requires registration of certain medical devices and IVDs, especially those of higher risk called “notified devices.” Although the list includes specific regulated products, the CDSCO, from time to time, keeps adding products to the list. Since April 1, 2020, new changes came into effect that requires all medical devices, including those beyond the previously notified medical devices, to be registered under The Drugs and Cosmetics Act of 1940.
How Medical Device Consulting Assists in CDSCO Registration
In recent years, the increasing regulations for medical device registration have made the whole process much more complex for companies. To ease the situation, it is important to appoint the services of an Indian authorized third-party regulatory compliance consultant such as Operon Strategists by the manufacturer to assist in device approvals and registration process. The team with considerable experience in medical device consulting provides a full spectrum of services to assist the manufacturer in determining whether the device requires registration in India, and if needed, to provide full regulatory support in obtaining a medical device license, working directly with the CDSCO on an ongoing basis as well as vigilance/adverse event reporting.
The Indian agent acts as a liaison between the manufacturer and the medical device division of CDSCO. The services include, but are not limited to:
- Assess your product’s classification in relation to a list of regulated medical device categories.
- Prepare all documents and materials needed for the product registration application if your distributor requests it, and submit it to CDSCO.
- Assist with requests for additional information from CDSCO.