On October 29, 2025, the Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution, notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. This amendment introduces specific provisions for packages containing medical devices, aligning the Legal Metrology (Packaged Commodities) Rules, 2011, with the Medical Devices Rules, 2017. 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, while the requirement to make mandatory declarations remains. Additionally, the relaxation under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011 will not apply in cases where the Medical Devices Rules, 2017 are applicable. 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, declarations may be made as per the provisions of the Medical Devices Rules, 2017. The amendment aims to provide a single, consistent labelling standard for medical devices, eliminate confusion from overlapping rules, strengthen consumer protection, promote Ease of Doing Business, and enable simplified and effective enforcement. The release ID is 2183777.
Key Entities Referenced
Legal Metrology (Packaged Commodities) Amendment Rules, 2025: Amendment to the Legal Metrology (Packaged Commodities) Rules to align with Medical Devices Rules, 2017 for packages containing medical devices.
Medical Devices Rules, 2017: Regulations governing the standards and declarations for medical devices packaging; certain provisions now prevail over Legal Metrology Rules for such devices.
Legal Metrology (Packaged Commodities) Rules, 2011: The original set of rules for packaged commodities, whose application is now modified concerning medical devices due to the 2025 amendment.
Department of Consumer Affairs: The notifying ministry for the Legal Metrology (Packaged Commodities) Amendment Rules, 2025.
Ministry of Consumer Affairs, Food & Public Distribution
Department of Consumer Affairs Notifies Legal
Metrology (Packaged Commodities)
Amendment Rules, 2025
Harmonisation with Medical Device Rules to Benefit
Consumers, Industries and Regulators
Clear Declarations – Stronger Consumer Confidence
Aligned Standards for a Healthier India
Towards a Transparent and Healthy India
Atmanirbhar Bharat through Regulatory Harmony
Posted On: 29 OCT 2025 4:14PM by PIB Delhi
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 the Consumers in providing a single, consistent labelling standard for
medical devices, eliminating confusion arising from overlapping rules to ensures clear, accurate and
uniform labelling designed specifically for healthcare products. It will strengthen consumer
protection by aligning with specialized medical device labelling 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
labelling 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.
This harmonisation reflects the Government’s continued commitment to fostering a business-friendly
regulatory environment while ensuring robust consumer protection in the sensitive healthcare domain.
By aligning the Legal Metrology Rules with the Medical Devices Rules, the amendment furthers
India’s vision of Ease of Living and Ease of Doing Business, ensuring both clarity for industry and
confidence for consumers.
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RT
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