BIS to prioritize the development of standards for 214 critical medical devices
The Bureau of Indian Standards (BIS) has announced plans to develop standards for 214 critical medical devices, with phased completion targeted by December 2025. This initiative aligns with the National Medical Device Policy, 2023, and aims to enhance the safety, efficacy, and global competitiveness of Indian medical devices.
Key Highlights:
- Identification of Critical Devices: In consultation with the Department of Pharmaceuticals (DoP), BIS has identified 214 critical medical devices requiring standardization. These include septal closure devices, plasma sterilizers, and phototherapy machines.
- Focus on Assistive Technologies: BIS is also developing standards for innovative assistive products such as therapeutic footwear, portable ramps, braille displays, and fall detectors. These standards aim to support individuals with disabilities and enhance their quality of life.
- Existing Standards: To date, BIS has published over 1,700 standards for the medical sector, covering specialties like cardiology, neurology, orthopedics, and ophthalmology. Approximately 1,200 of these standards specifically focus on critical medical devices, including cardiac pacemakers, heart valves, ventilators, and advanced diagnostic tools like X-ray machines and MRI systems.
Implications:
By aligning with the Medical Devices Rules, 2017, and the National Medical Device Policy, 2023, BIS aims to establish a robust regulatory framework that prioritizes public safety while fostering innovation. This effort is expected to build trust among healthcare providers, consumers, and international stakeholders, solidifying India’s reputation as a leader in healthcare innovation.
The development of these standards is anticipated to ensure that Indian medical devices are safe, effective, and globally competitive, thereby improving healthcare quality, safety, and reliability across the country.
