The Bureau of Indian Standards (BIS) has released a massive list of new and revised standards under its Medical Equipment and Hospital Planning Department (MHD), reflecting a strategic push in 2025 to formalize quality, safety, and performance benchmarks across India’s rapidly growing healthcare and medical device sector.
The comprehensive list covers 20 different categories, ranging from basic surgical tools and hospital infrastructure to advanced biotechnology and complex surgical implants, ensuring alignment of domestic manufacturing with global requirements.
Key Focus on Implants and Advanced Technology
The standards demonstrate a strong emphasis on establishing rigorous protocols for critical, high-risk devices, often through the adoption or modification of international ISO and IEC standards:
Orthopaedic and Joint Implants (Category MHD 02): New specifications detail the materials and mechanical testing for surgical implants, including standards for wear resistance and durability performance of components for hip and knee joint prostheses (e.g., Implants for Surgery – Wear of Total Knee Prostheses Part 5 Durability Performance of the Patellofemoral Joint, and Wear of Implant Materials – Polymer and Metal Wear Particles).
Endoscopes and Advanced Surgical Tools (Category MHD 01): Updates focus on modern surgical equipment, including detailed specifications for capsule endoscopes, as well as revised standards for plastic surgery instruments and various surgical retractor patterns.
Electromedical and Imaging Equipment (Category MHD 15): New standards reflect modern regulatory requirements for complex machinery, including specifications for Magnetic resonance equipment for medical diagnosis and standards for essential operating room equipment like Surgical luminaires and Operating tables.
Standardization in New Medical Fields
The 2025 standards include crucial groundwork for emerging and technology-heavy segments:
Health Informatics (Category MHD 16): This area sees extensive standardization of device interoperability, nomenclature, and communication protocols for personal health devices (like continuous glucose monitors and weighing scales), ensuring digital health data integrity.
Medical Biotechnology and IVDs (Category MHD 17/18): Standards cover the technical requirements for In-vitro Diagnostic (IVD) devices and specialized procedures for the Biocompatibility evaluation of breathing gas pathways and the safe handling of cells for therapeutic use.
Hospital and Surgical Infrastructure (Categories MHD 12/14): New specifications detail requirements for essential infrastructure, including Aseptic Processing procedures for sterile medical devices and standards for hospital furniture and equipment like the Blood Donor Couch and Dialysis Chair.
The extensive number of new standards and revisions signifies a concerted effort by BIS to raise the quality compliance barrier for domestic medical device manufacturing, thereby enhancing patient safety and reinforcing India’s position in the global supply chain.