01 November 2025, India — The Bureau of Indian Standards (BIS), India’s National Standards Body, has announced a significant step toward strengthening the regulatory and quality framework for medical devices in India. In a press release issued on November 25, 2024. BIS Strengthens Patient Safety for Medical Devices, with Completion Targeted by December 2025.The Ministry of Consumer Affairs highlighted BIS’s ongoing efforts to make medical assistive technology more reliable and affordable.
STRENGTHENING MEDICAL DEVICE STANDARDS THROUGH THE 2023 POLICY
As part of its alignment with the National Medical Device Policy, 2023 and the Medical Devices Rules, 2017, BIS is prioritizing the development of standards for 214 critical medical devices, with completion targeted by December 2025. These devices were identified in consultation with the Department of Pharmaceuticals (DoP) and include technologies such as septal closure devices, plasma sterilizers, and phototherapy machines. In addition to high-risk and therapeutic devices, BIS is also focusing on innovative assistive products that improve the lives of people with disabilities. These include:
- Therapeutic footwear
- Portable ramps
- Braille displays
- Fall detectors
OVER 1,700 STANDARDS PUBLISHED FOR MEDICAL SECTOR
To date, BIS has published more than 1,700 standards in the medical field. Of these, approximately 1,200 focus directly on medical devices critical to healthcare across specialties such as cardiology, neurology, orthopaedics, ophthalmology, and more.
Devices covered include:
- Life-saving equipment: Cardiac pacemakers, heart valves, ventilators, haemodialysis machines
- Diagnostic tools: X-ray machines, CT scanners, MRI systems, blood glucose monitors
- Assistive technology: Hearing aids, wheelchairs, Jaipur Foot, and tactile pathways
These efforts aim to ensure Indian medical devices are safe, effective, and globally competitive, helping to build trust among healthcare providers, patients, and international partners.
HOW THIS IMPACTS MEDICAL DEVICE MANUFACTURERS
To date, BIS has published more than 1,700 standards in the medical field. Of these, approximately 1,200 focus directly on medical devices critical to healthcare across specialties such as cardiology, neurology, orthopaedics, ophthalmology, and more.
Devices covered include:
- Life-saving equipment: Cardiac pacemakers, heart valves, ventilators, haemodialysis machines
- Diagnostic tools: X-ray machines, CT scanners, MRI systems, blood glucose monitors
- Assistive technology: Hearing aids, wheelchairs, Jaipur Foot, and tactile pathways
These efforts aim to ensure Indian medical devices are safe, effective, and globally competitive, helping to build trust among healthcare providers, patients, and international partners.
HOW THIS IMPACTS MEDICAL DEVICE MANUFACTURERS
- Manufacturers must align their product specifications, labeling, and documentation with BIS requirements.
- By December 2025, devices within the 214-category list will be expected to comply with new or revised standards.
BIS standards are increasingly being used in CDSCO evaluations and public health procurement decisions.
HIGHLIGHTED INDIAN STANDARDS
A selection of key BIS standards published so far includes:
Device Category | Indian Standard Code |
Cardiac Pacemakers | IS 13450 (Part 2/Sec 31): 2021 |
Heart Valves | IS 17840 |
Hip and Knee Implants | IS 12375 |
Ventilators | IS 13450 (Part 2/Sec 12): 2023 |
Infant Incubators | IS 13450 (Part 2/Sec 19): 2023 |
Radiant Warmers | IS 13450 (Part 2/Sec 21): 2023 |
Haemodialysis Machines | IS 13450 (Part 2/Sec 16): 2019 |
Infusion Pumps | IS 13450 (Part 2/Sec 24): 2019 |
X-ray & CT Machines | IS 7620 (Part 1): 1986 |
MRI Systems | IS 13450 (Part 2/Sec 33): 2018 |
ECG & Ultrasound Devices | IS 13450 (Part 2/Sec 25, 37): 2018–2019 |
Blood Pressure Monitors | IS 13450 (Part 2/Sec 34): 2019 |
Glucose Monitors | IS/ISO 15197: 2013 |
Pulse Oximeters | IS/ISO 80601-2-61: 2017 |
LOOKING AHEAD: REVISED GUIDELINES TO STRENGTHEN QUALITY COMPLIANCE IN INDIA
This large-scale standardization initiative not only strengthens India’s internal healthcare quality infrastructure but also positions Indian medical devices to become more globally accepted and trusted. BIS’s ongoing efforts represent a foundational shift toward a standard-driven, innovation-friendly, and patient-safe healthcare environment.