BIS Enhances Medical Device Standards in India
The Bureau of Indian Standards (BIS) is taking significant steps to improve medical assistive technology in India. As the nation’s National Standards Body, BIS recognizes the increasing demand for reliable and affordable medical devices. The organization is actively developing standards for a variety of innovative products, including therapeutic footwear, portable ramps, braille displays, and fall detectors. These advancements aim to support individuals with disabilities and enhance their overall quality of life.
Focus on Critical Medical Devices
In alignment with the National Medical Device Policy of 2023, BIS is prioritizing the development of standards for 214 critical medical devices. This initiative is a result of consultations with the Department of Pharmaceuticals (DoP). The list includes essential devices such as septal closure devices, plasma sterilizers, and phototherapy machines. The phased completion of this initiative is expected by December 2025.
BIS’s commitment to creating these standards is crucial for ensuring that medical devices are safe, effective, and accessible. By focusing on these critical devices, BIS aims to address the pressing needs of healthcare providers and patients alike. The development of these standards will also help in establishing a robust regulatory framework that prioritizes public safety while encouraging innovation in the medical sector.
Enhancing Healthcare Quality and Safety
BIS is not only focused on developing standards for medical devices but is also dedicated to improving the overall quality and safety of healthcare in India. By creating robust standards for medical devices and services, BIS is working to ensure that healthcare providers can deliver safe and reliable care. The organization aligns its efforts with the Medical Devices Rules of 2017 and the National Medical Device Policy of 2023.
This alignment is instrumental in establishing a comprehensive regulatory framework that emphasizes public safety. By fostering innovation in the medical device sector, BIS is helping to build trust among healthcare providers, consumers, and international stakeholders. This trust is vital for solidifying India’s reputation as a leader in healthcare innovation.
Comprehensive Standards for Diverse Medical Specialties
BIS has published over 1,700 standards for the medical sector, covering various specialties such as cardiology, neurology, orthopaedics, and ophthalmology. Among these, approximately 1,200 standards specifically focus on medical devices that are critical to healthcare. Some of the life-saving devices covered include cardiac pacemakers, heart valves, ventilators, and haemodialysis machines.
Additionally, advanced diagnostic tools such as X-ray machines, CT scanners, MRI systems, and blood glucose monitors are also included in these standards. Assistive technologies like hearing aids, wheelchairs, and tactile pathways for visually impaired individuals are part of BIS’s comprehensive approach. By ensuring that these medical devices meet high standards, BIS is working to make Indian medical devices safe, effective, and globally competitive.
Key Indian Standards for Medical Devices
BIS has developed several key Indian Standards that are vital for the medical device sector. These include standards for cardiac pacemakers (IS 13450 Part 2/Sec 31: 2021), heart valves (IS 17840), and hip and knee implants (IS 12375). Other important standards cover ventilators, infant incubators, and haemodialysis machines.
Moreover, advanced diagnostic tools are also addressed, with standards for X-ray and CT machines (IS 7620 Part 1: 1986), MRI systems (IS 13450 Part 2/Sec 33: 2018), and ultrasound devices (IS 13450 Part 2/Sec 37: 2019). Monitoring devices, including blood pressure monitors and blood glucose monitors, are also included in the standards.
These efforts by BIS ensure that Indian medical devices not only meet national safety and efficacy requirements but also compete on a global scale. By building trust among healthcare providers and consumers, BIS is solidifying India’s position as a leader in healthcare innovation.
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