Summary of key changes and its impacts on medical device industry in India due to the introduction of Indian Medical Rules, 2017

1. A New Regulatory Model for India
(Medical Device Rules, 2017)
After a long wait, the medical devices have found a new home under Indian regulatory framework. The
new Medical Device Rules (the Rules, hereinafter) was introduced in 2017 with an implementation
period of 2018. For the first time, the Rules brought a ray of hope for medical devices to be treated
differently than drugs although the recent notification from the agency about treating some more
Implantable devices (e.g. MRI equipment, bone marrow separator etc.) as drugs starting from April 2020
is disappointing for medical device industry. Moreover, clinical investigation waivers under the Rules for
medical devices that have been approved in US, UK, Australia, Canada, Japan or EU (recently added)
where the device has been on market for at least 2 years is not satisfactory. It’s understandable that the
government is trying to remove regulatory bottlenecks and boost state-of-the-art medical devices for
Indian citizens, there’s still a long way to go for a concrete medical device regulatory framework in the
country. At least, a seed has been sown!
Major changes and Impacts on Medical Device sector due to The Rules:
1. Both State and Central Licensing Authority are held responsible for approving Medical Devices
depending on the device class. Additionally, the DCGI will be responsible for overseeing clinical
trials, import licenses, device classification etc.
Impact: This means more involvement from the agency, transparency in the process and
tracking of products going on the market under the agency’s purview.
2. The classification is determined by the DCGI unlike countries like the US & EU.
Impact: Eliminates the chances of rejecting proposed classification by manufacturers and helps
shortening the overall approval timelines.
3. Thorough Inspections required for all Class C & Class D (high risk) devices. Additionally, approval
from the Agency required for significant changes (design change, change in Indication, material
change etc.) made to the devices already placed on market.
Impact: Increases safety and performance of the devices. Also, increases the Agency’s visibility
on Medical Device development.
4. Almost all the Clinical Investigations require CDSCO approval except the ones conducted for
academic purposes where only Ethics Committee approval is needed.
Impact: Increased transparency in clinical trials, data gathering, GCP compliance and reduced
malpractice towards research participants.
5. The concept of Periodic Safety Update Reports (PSURs) is introduced under the Rules and post-
market data requirements have been increased.
Impact: Directly impacts the Safety, Quality and Performance of medical devices on their long-
term use.
Right Implementation of the Rules is going to have a long-term effect on the market. Since the
requirements in the Medical Device Rules are streamlined with international standards and EU medical
device requirements, it is going to open the doors for foreign investment, domestic device development
(boosting ‘Make in India’ initiative) as well as decreased dependency on import of Medical Devices from
foreign countries.