Indian Government Aligns Packaging Rules for Medical Devices, Simplifies Compliance

The Indian government has amended its packaging regulations to align with the Medical Devices Rules, 2017, aiming to eliminate overlapping standards and streamline compliance for manufacturers while ensuring clearer consumer information in the healthcare sector.

Packaging Norms Now Governed by Medical Devices Rules

On October 29, 2025, the Centre notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, targeting the medical device sector. Under these updated regulations, any packaging declarations, such as font sizes of numerals and letters for medical devices, will now follow the Medical Devices Rules, 2017, instead of general metrology laws. 

This shift simplifies obligatory labelling requirements, offering greater clarity and reducing red tape for manufacturers.

Key Compliance Simplifications and Regulatory Clarity

A critical change under these rules is the inapplicability of Rule 33 exemptions from the Legal Metrology (Packaged Commodities) Rules, 2011, to medical devices. These exemptions will remain confined to non-medical products. 

Furthermore, the requirement to display declarations on the Principal Display Panel has been scrapped for medical devices, allowing adherence solely to the 2017 framework. This targeted alignment reduces ambiguity and standardises practices across the healthcare sector.

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Consumer Confidence and Industry Ease Strengthened

This rule harmonisation ensures that consumers receive labelling aligned specifically with healthcare needs, enhancing transparency and trust. Uniformity in labelling also aids legal metrology enforcement officers, offering clearer jurisdiction and easing monitoring responsibilities. The amendment supports India's broader Ease of Doing Business and Ease of Living initiatives, especially in sensitive sectors like healthcare and pharmaceuticals.

Conclusion

The amendment of packaging norms for medical devices is a major regulatory upgrade driven by the need for clarity, efficiency and sector-specific governance. The alignment with the Medical Devices Rules, 2017 streamlines compliance for businesses and enables consumers to make more informed healthcare choices.

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