The Union health ministry has notified the Medical Devices Rules, 2017. The rules will come into effect from January 1, 2018. This rule has been introduced for the first time in the world.
In accordance with the new rule, manufacturers of medical devices must follow the essential principles of safety and performance of medical devices as may be specified in the guidelines published by the Ministry of Health and Welfare of the Family To the Central Government, Contemporary scientific and technological knowledge and development, provided that the directives to be specified are in conformity with the provisions of the law and these rules.
The new rules have been formulated in accordance with the framework of the Global Harmonization Task Force (GHTF) and are in line with international best practice.
Only 15 categories of medical devices are currently regulated as drugs and to this extent current regulatory practices in India are not fully adapted to the requirements of the medical devices sector in the country.
These rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component.
The medical devices could range from simple devices such as thermometers and disposable gloves to x-ray, CT, MRI machines and implantable devices such as stents and artificial joints.
As per the newly notified rules, medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.
The medical device should conform to the standards laid down by the Bureau of Indian Standards established under Section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
The industry will no longer have to follow strict clinical trial guidelines covering four phases, such as drug testing. The new rules have eased standards of licensing and conduct of clinical trials, and also reduced the manufacturer-regulator interface by favoring the digital platform. Clinical trials norms have been relaxed.
The Rules will provide an enabling environment for India to promote specific innovation and improve the accessibility and affordability of medical devices around the world by taking advantage of the comparative advantage of cost Manufacturing facilities in India. Implementation of these rules will ensure the highest quality, safety and performance of medical devices.
