Bridging the gap: a paradigm shift in medical device regulations in India.

Summary: India is one of the biggest markets in the world for medical devices like X-rays, pacemakers, and artificial joints. As more people get sick with long-term illnesses, the need for these tools is growing fast. But India's rules for making and selling these devices are very old. A big problem with bad hip implants showed that the old rules from 1940 do not keep patients safe. To fix this, India made new rules in 2017 and proposed a brand-new law in 2022. This paper looks at why the old rules failed and how the new bill hopes to protect patients better.