Context:
Recently, the Department of Consumer Affairs under the Ministry of Consumer Affairs, Food and Public Distribution, notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. The amendment aims to harmonise the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017, particularly for packages containing medical devices..
Key Features:
1. Alignment with Medical Devices Rules:
o The amendment introduces specific provisions for packages containing medical devices, harmonising the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017.
2. Declaration Standards:
o Mandatory declarations on medical device packaging remain required.
o However, the font size and dimensional standards prescribed under the Medical Devices Rules will now apply, replacing those under Legal Metrology Rules.
o Relaxations under Rule 33 of the Legal Metrology Rules do not apply to medical devices.
o Declarations on the Principal Display Panel are optional for medical devices and can follow Medical Devices Rules.
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Objectives:
o Ensure regulatory harmony between overlapping frameworks.
o Reduce compliance ambiguity for manufacturers.
o Enhance consumer protection in the healthcare sector through clear and uniform labelling.
Conclusion:
The Legal Metrology (Packaged Commodities) Amendment Rules, 2025 exemplify a balanced approach to regulation, ensuring consumer safety, industry clarity, and regulatory efficiency. By harmonising labelling standards for medical devices, the amendment reduces compliance ambiguity, strengthens consumer protection, and supports India’s broader vision of a robust, transparent, and self-reliant healthcare ecosystem.
