One Label, One Rule: Centre Harmonises Legal Metrology Norms with Medical Device Standards
New Delhi: In a significant regulatory move aimed at harmonizing labelling standards and reducing compliance overlap, 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, aligning provisions of the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017 for packages containing medical devices.
Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution, has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025.
The amendment introduces specific provisions for packages containing medical devices, aligning the Legal Metrology (Packaged Commodities) Rules, 2011, with the Medical Devices Rules, 2017. This step ensures regulatory harmony, reduces compliance ambiguity, and enhances consumer protection in the healthcare sector.
The amendment provides that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017 shall prevail for the height and width of numerals and letters used for making declarations. This means that while the requirement to make mandatory declarations remains, the specific font size and dimensional standards prescribed under the Medical Devices Rules shall apply instead of those under Legal Metrology (Packaged Commodities) Rules.
Further, the relaxation under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011, which provides certain exemptions in declarations, will not apply in cases where the Medical Devices Rules, 2017, are applicable. This ensures that any relaxations under Legal Metrology apply only to declarations required under these Rules and not to those covered by the Medical Devices framework.
Additionally, the amendment clarifies that the requirement of making declarations on the Principal Display Panel as per the Legal Metrology (Packaged Commodities) Rules is not mandatory for medical devices. Instead, such declarations may be made as per the provisions of the Medical Devices Rules, 2017.
This amendment will benefit Consumers in providing a single, consistent labeling standard for medical devices, eliminating confusion arising from overlapping rules to ensure clear, accurate, and uniform labeling designed specifically for healthcare products. It will strengthen consumer protection by aligning with specialized medical device labeling norms.
It will also benefit the industry by removing ambiguity between two regulatory frameworks, ensuring clarity, predictability, and reducing compliance burden by requiring adherence to only one set of labeling standards to promote Ease of Doing Business by streamlining regulatory obligations and avoiding duplication.
The Legal Metrology Enforcement officers will enable simplified and effective enforcement with clearly defined jurisdiction and applicability. It will promote uniform interpretation and compliance across States and enforcement agencies.
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