The Bureau of Indian Standards (BIS), India’s foremost authority on standards, has pinpointed 214 essential medical devices for accelerated standards development, with completion expected by next year’s close.
In harmony with the National Medical Device Policy, 2023, BIS is enhancing standards for 214 pivotal medical devices.
“These critical devices have been recognized in coordination with the Department of Pharmaceuticals (DoP),” the Bureau declared. This includes devices like septal closure systems, plasma sterilization equipment, and phototherapy units. The initiative is progressing towards staged finalization by December 2025,” BIS mentioned in a release.
This initiative addresses the increasing demand for dependable and cost-effective medical technology by crafting standards for innovative solutions, such as therapeutic footwear, mobile ramps, braille readers, and fall alert systems, which provide assistance to those with disabilities and enrich their living standards.
The Bureau is also spearheading enhancements in healthcare quality, integrity, and dependability by establishing comprehensive norms for medical devices and services, aligning with the Medical Devices Rules, 2017, and the National Medical Device Policy, 2023. Such actions are paving the path towards a vigorous regulatory architecture prioritizing public safety while encouraging innovation, noted BIS.
Having released over 1,700 standards pertaining to the healthcare domain, BIS covers fields such as cardiology, neurology, orthopedics, ophthalmology, among many. Roughly 1,200 of these standards pertain particularly to crucial medical apparatus, encompassing life-saving equipment like cardiac pacemakers, heart valves, ventilators, and dialysis devices; sophisticated diagnostic instruments like X-ray apparatus, CT scanners, MRI units, and blood glucose monitoring systems.
In addition, criteria were established for assistive technologies like hearing aids, wheelchairs, Jaipur Foot, and sensory pathways for those with visual impairments.
Data from BIS showcases development of 249 standards in dentistry, 205 for disposable surgical tools, 155 for orthopedic gadgets, 152 for assistive products, 138 for health informatics, 122 for surgical equipment, 112 in ophthalmology, 105 for electromedical apparatus, 81 for anesthesia, and 70 each for ENT and gynecology gadgets, 69 for cardiovascular care, while 243 standards encompass other devices.
BIS standards in this field assure that medical devices are safe, function efficiently, and are competitive globally. These efforts strive to foster trust among healthcare practitioners, consumers, and international partners while reinforcing India’s status as a pioneer in healthcare advancements.
Prominent Indian Standards from BIS include IS 13450 (Part 2/Sec 31): 2021 for Cardiac Pacemakers, IS 17840 for heart valves, IS 12375 for hip and knee replacements, IS 13450 (Part 2/Sec 12): 2023 for ventilators, IS 13450 (Part 2/Sec 19): 2023 for neonatal incubators and IS 13450 (Part 2/Sec 21): 2023 for radiant warmers, along with IS 13450 (Part 2/Sec 16): 2019 for dialysis machines, and IS 13450 (Part 2/Sec 24): 2019 for infusion apparatus.
Moreover, standards have been established for advanced imaging and diagnostic machines such as X-ray and CT equipment (IS 7620 (Part 1): 1986), MRI systems (IS 13450 (Part 2/Sec 33): 2018), Ultrasound scanners (IS 13450 (Part 2/Sec 37): 2019) and ECG devices (IS 13450 (Part 2/Sec 25): 2018).
Monitoring apparatus like BP monitors (IS 13450 (Part 2/Sec 34): 2019), glucose trackers (IS/ISO 15197: 2013), and pulse oximeters (IS/ISO 80601-2-61: 2017), are already integrated within Indian Standards, BIS added.