SDG 3: Good Health & Well-being | SDG 9: Industry, Innovation & Infrastructure
Institutions: Ministry of Consumer Affairs, Food & Public Distribution | Department of Consumer Affairs
The Department of Consumer Affairs has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, which specifically harmonise the packaging and labelling standards for medical devices by aligning the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017.
Key changes include:
For medical-device packages, font sizes and dimensions for labelling will follow the Medical Devices Rules, not the older Legal Metrology rules.
The exemption under Rule 33 of the Legal Metrology Rules (which provided relaxations in declarations) will not apply for items covered under Medical Devices Rules — ensuring consistent and stricter labelling for these products.
The requirement to declare info on the “Principal Display Panel” under Legal Metrology now becomes optional for medical devices; instead, the Medical Devices Rules’ provisions apply.
This move strengthens consumer protection by eliminating dual-framework ambiguity in the healthcare product sector. It simplifies compliance for manufacturers of medical devices and enables regulators to enforce one unified standard. It aligns with the government’s focus on Ease of Doing Business and health-product safety, complementing initiatives under the National Health Policy and frameworks for medical-device regulation in India.
Relevant Question for Policy Stakeholders:
How can regulators ensure that all stakeholders — device manufacturers, importers, and state-level legal-metrology authorities — are fully trained and equipped for this transition, thereby avoiding gaps in compliance or enforcement in the medical-device sector?
Follow the full news here: PIB Press Release 2183777