Govt aligns packaging rules for medical devices, eases compliance burden

New Delhi, Oct 29 (PTI) The government has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, introducing specific provisions for medical device packaging that align with the Medical Devices Rules, 2017.

The move is aimed at eliminating regulatory overlap and enhancing consumer protection in the healthcare sector, the consumer affairs ministry said in a statement.

The amendment establishes that for packages containing medical devices, the Medical Devices Rules, 2017 will take precedence over general packaging norms when it comes to the height and width of numerals and letters used in product declarations.

While mandatory disclosures remain compulsory, the font size and dimensional standards will now follow medical device-specific regulations rather than general legal metrology standards.

Significantly, the relaxations provided under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011 -- which exempt certain declarations -- will no longer apply to medical devices.

This ensures that exemptions under legal metrology apply only to non-medical products and not to items governed by the specialised medical devices framework.

The amendment also clarifies that declarations need not be made on the Principal Display Panel as mandated by the Legal Metrology Rules. Instead, labelling can follow the provisions of the Medical Devices Rules, 2017.

By requiring adherence to a single set of labelling standards, the amendment reduces compliance burden and promotes ease of doing business.

For consumers, the harmonisation provides a consistent labelling standard for medical devices, eliminating confusion and ensuring clear, accurate information tailored to healthcare products.

Legal metrology enforcement officers will also benefit from clearly defined jurisdiction and applicability, enabling uniform interpretation and compliance across states and enforcement agencies.

The harmonisation reflects the government's push towards simplifying regulations while maintaining robust consumer safeguards, particularly in the sensitive healthcare domain. The amendment is seen as a step forward in India's Ease of Living and Ease of Doing Business initiatives. PTI LUX TRB