New Delhi: In a move aimed at simplifying regulations and strengthening consumer protection, the Department of Consumer Affairs under the Ministry of Consumer Affairs, Food and Public Distribution has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025.
The amendment brings medical device packaging under a harmonised framework by aligning provisions of the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017. The step seeks to eliminate overlap, ensure uniformity in labelling, and reduce compliance burden for the healthcare industry while enhancing transparency for consumers.
Under the amendment, for packages containing medical devices, the Medical Devices Rules, 2017 will now take precedence in determining the height and width of numerals and letters used in mandatory declarations.
This means that while the requirement for labelling and declarations remains, the font size and display specifications will follow the medical device norms instead of the general metrology guidelines.
Furthermore, the relaxation under Rule 33 of the Legal Metrology (Packaged Commodities) Rules — which allows certain exemptions — will not apply when the Medical Devices Rules are in force. Similarly, the requirement of displaying information on the Principal Display Panel under the Legal Metrology Rules will no longer be mandatory for medical devices, provided the declarations comply with the Medical Devices Rules.
Benefits for consumers and industry
Officials said the harmonisation will provide a single, consistent labelling standard for medical devices, helping consumers by ensuring clear, accurate, and uniform information on healthcare products.
For manufacturers and distributors, the amendment removes ambiguity arising from dual regulatory requirements, enabling ease of doing business through predictable and simplified compliance procedures.
Legal Metrology Enforcement Officers will now operate under a clearer jurisdictional framework, ensuring uniform enforcement across states and agencies.
The government said the amendment reflects its commitment to regulatory clarity, transparency, and consumer welfare in the healthcare sector. By creating harmony between two key regulatory regimes, it advances India’s twin goals of Ease of Living and Ease of Doing Business, while fostering Atmanirbhar Bharat through streamlined governance.
The Ministry added that the move will help create a transparent, consumer-friendly, and business-supportive regulatory environment, especially in the sensitive and fast-growing medical devices market.
