The Central Government in India has recently drafted legislation to ensure quality control of vital life-saving medical devices such as endoscopes and pacemakers. Drafted by the Sree Chitra Tirunal Institute for Medical Sciences and Technology, the draft has been forwarded to the Ministry of Health and Family Welfare.
Some devices are regulated by the Drug Controller General of India. However, there is no regulatory body establishing and enforcing standards on medical devices. The bill proposes establishing regulatory guidelines to test and certify medical devices introduced into India. Foreign imported devices may also be required to be certified based on these regulatory guidelines.
Though India has already passed legislation this past March on devices such as cardiac stents, catheters, bone cements, and other sterile medical devices, the proposed bill would affect all medical devices.