The Bureau of Indian Standards (BIS) has introduced a comprehensive set of new and revised standards under its Medical Equipment and Hospital Planning Department (MHD).

The move marks a significant policy shift in 2025, aiming to formalize quality, safety, and performance benchmarks across India’s growing medical device and healthcare ecosystem.

The latest update includes 20 distinct categories, covering areas from basic surgical tools and hospital infrastructure to advanced biotechnology and complex surgical implants.

These standards are structured to reinforce domestic manufacturing and bring Indian products align with international ISO and IEC benchmarks, strengthening the nation’s position in the global medical supply chain.

Key Focus on Implants and Advanced Technology

The 2025 revision places strong prominence on high-risk and crucial medical devices, mainly implants and advanced surgical systems.

• Orthopaedic and Joint Implants (Category MHD 02): New specifications focus on material quality and mechanical testing for implants used in hip and knee replacements. They introduce detailed standards for wear resistance and durability performance involving rules for the patellofemoral joint and polymer and metal wear particles in surgical prostheses.
• Endoscopes and Surgical Tools (Category MHD 01): Updated standards now cover capsule endoscopes and modern plastic surgery instruments, beside revised requirements for surgical retractors to ensure better precision and safety in nominally invasive procedures.
• Electromedical and Imaging Equipment (Category MHD 15): BIS has also rolled out standards for magnetic resonance imaging (MRI) systems and other dangerous operating room equipment, such as surgical luminaires and operating tables, reflecting updated global safety protocols.

Standardization in Emerging Medical Fields

The 2025 standards extend beyond traditional devices to include fast-evolving, technology-driven healthcare areas.

• Health Informatics (Category MHD 16): This section announces frameworks for interoperability, nomenclature, and communication protocols for personal health devices such as continuous glucose monitors and digital weighing scales. The focus is on enhancing data integrity and reliability in India’s expanding digital health ecosystem.
• Medical Biotechnology and IVD Devices (Categories MHD 17/18): These principles highlight technical and biocompatibility requirements for in-vitro diagnostic (IVD) devices and specify safe handling and assessment procedures for cell-based therapeutic applications.
• Hospital and Surgical Infrastructure (Categories MHD 12/14): New specifications define aseptic processing procedures for sterile medical devices and set design standards for essential hospital furniture, including blood donor couches and dialysis chairs, to enhance patient safety and comfort.

Strengthening India’s Global Healthcare Footprint

The extensive list of new and revised BIS standards signals a strategic effort to raise compliance levels across India’s healthcare manufacturing ecosystem.

By tightening performance and safety norms, BIS aims to ensure that Indian-made medical devices meet international quality expectations, promoting both patient safety and export competitiveness.

This nationwide update reflects India’s growing focus on medical technology innovation, digital health adoption, and global standardization, positioning the country as a key player in the next era of healthcare manufacturing.