INDIA, 13 DEC 2025 — The Indian government has officially published the Legal Metrology Amendment Rules, 2026 in the Official Gazette on January 7, 2026. This notification introduces a comprehensive replacement for Part VII-A of the Eighth Schedule, establishing rigorous new metrological and technical requirements for non-invasive non-automated sphygmomanometers.
Here is an overview of the key updates and deadlines that medical device manufacturers must now comply with to maintain market access in India.
LEGAL METROLOGY AMENDMENT RULES : OVERVIEW OF THE NEW REQUIREMENTS
The 2026 amendment focuses on ensuring the precision and safety of manual blood pressure monitors, whether they use mercury, aneroid (mechanical), or electronic sensing elements.
- Expanded Scope: The rules cover the entire device including the manometer, inflatable cuff (bladder and sleeve), tubing, connectors, and valves.
- Measurement Units: Devices must indicate blood pressure in either kilopascals (kPa) or millimeters of mercury (mmHg).
- Strict Error Margins: The maximum permissible error for cuff pressure at any point on the scale is now fixed at ±0.4 kPa (±3 mmHg).
NON-INVASIVE AND NON-AUTOMATED SPHYGMOMANOMETERS: CRITICAL TECHNICAL STANDARDS FOR 2026
Manufacturers must update their technical documentation and production processes to meet several new safety and performance benchmarks:
1. Design and Safety Enhancements
- Safety Connectors: Luer lock and Luer slip connectors are now prohibited to prevent accidental connection to IV fluid systems.
- Cuff Dimensions: Bladder length should be approximately 80% of the limb circumference at the midpoint of the cuff’s range.
- Tamper Proofing: Devices must include means to prevent unauthorized access to the measuring mechanism; any tampering must be clear to the operator.
2. Environmental and Stress Testing
- Storage Resilience: Sphygmomanometers, both with and without electronic components, must maintain accurate cuff pressure readings (within ±0.4 kPa or ±3 mmHg) even after being stored under extreme conditions. For devices without electronics, this means 24 hours at −20°C followed by 24 hours at 70°C with 85% humidity. For devices with electronics, the storage conditions are 24 hours at −5°C and 50°C with 85% humidity. In both cases, the devices must be stored unpacked to ensure they meet the required accuracy standards.
- Mechanical Strength: Handheld monitors must survive a free fall from 25 cm. Devices labeled “Shock Resistant” must survive a 1-meter fall.
- Durability Testing: Aneroid manometers must undergo 10,000 alternating pressure cycles and maintain accuracy within 3 mmHg afterward.
COMPLIANCE CHECKLIST FOR MANUFACTURERS
To ensure conformity with the new rules, manufacturers should verify the following on their device markings and documentation:
Category | Requirement |
Markings | Name/Trademark, Serial Number, Year of Fabrication, and Model Approval Number. |
Cuff Information | Must show intended limb circumference and the center of the bladder. |
Instructions | Must include cleaning methods for reusable cuffs and handled-with-care instructions for mercury. |
Sealing | Control marks must be on seals to prevent opening the casing without detection. |
WHAT MANUFACTURERS NEED TO DO NOW
The rules came into force on the date of their publication (January 7, 2026).
- Submit for Model Approval: Manufacturers of new types of sphygmomanometers must submit at least three samples for testing according to the procedures in Part 2 of the notification.
- Review Technical Files: Align your Technical Documentation with the “Part VII-A” requirements, specifically focusing on the new hysteresis and durability testing procedures.
- Update Labeling: Ensure all required device and cuff markings are permanent and legible throughout the device’s service life.