The Government of India proposed some rules in 2017 for the medical device sector to strengthen the healthcare system in India and ensure the quality, safety, and performance of the medical devices manufactured or imported. These rules are called the Medical Device Rules, 2017 and come into force from 1st January 2018.
Compared to earlier guidelines and regulations on medical devices in India, these rules provide clear information about the risk-based classification of devices, timelines about each process, which is helpful to the industry to do proper planning for their market launch.
The Medical Device division in the CDSCO having the responsibility for implementing the rules. And, to meet the current healthcare and industry requirements, these Medical Device Rules are amending, after taking opinions from different sections, as required.