Consumer Affairs Ministry Aligns Labelling Norms For Medical Devices

The Department of Consumer Affairs on Wednesday notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, a move aimed at harmonising regulatory frameworks while strengthening consumer protection and easing compliance specifically for the medical device industry.

The Ministry of Consumer Affairs, Food and Public Distribution said the amendment specifically addresses packages containing medical devices, bringing the Legal Metrology (Packaged Commodities) Rules, 2011, in line with the Medical Devices Rules, 2017. “This step ensures regulatory harmony, reduces compliance ambiguity, and enhances consumer protection in the healthcare sector,” the Ministry noted.

Under the new provisions, requirements regarding font size and dimensional standards for package declarations of medical devices will follow the Medical Devices Rules, 2017. Additionally, exemptions under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011, will not apply where the Medical Devices Rules are relevant, said the Ministry.

It said the amendment will simplify labelling for consumers by providing a single, consistent standard for medical devices. “This removes confusion arising from overlapping rules, ensuring clear, accurate, and uniform labelling designed specifically for healthcare products. It will also boost consumer protection by aligning with specialised medical device labelling norms,” it added.

Industry players are also expected to benefit from the clarity provided by the harmonised rules. By eliminating ambiguity between two regulatory frameworks, the amendment offers predictability and reduces the compliance burden.

“This alignment furthers India’s vision of Ease of Living and Ease of Doing Business, ensuring clarity for industry and confidence for consumers,” the Ministry said.