Q1. What is a medical device in India?

Ans: Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of    disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

Q2. Whether medical devices are regulated in India?

Ans: Yes, import, manufacture, sale and distribution of medical devices are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.

Q3. Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?

Ans: The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 is available in Link:http://cdsco.nic.in/Drugs&CosmeticAct.pdf

Q4. Whether all medical devices are regulated in India?

Ans: No, however only notified medical devices are regulated in India.