Streamlined Medical Device Packaging Rules Enhance Consumer Protection

The government has taken a significant step towards refining the regulatory landscape for medical devices with the introduction of the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. This move is intended to align packaging regulations with the Medical Devices Rules, 2017, thereby minimizing regulatory overlap and enhancing consumer protection, according to a statement from the consumer affairs ministry.

The amendment signifies that for medical device packaging, the Medical Devices Rules will have precedence over general packaging norms, particularly in the use of numerals and letters in product declarations. Although mandatory disclosures will continue, regulations concerning font size and dimensions will now conform to those specific to medical devices.

This regulatory alignment eliminates exemptions previously applied under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011, thereby ensuring that legal metrology exemptions apply solely to non-medical products. Furthermore, the amendment mandates adherence to a unified set of labelling standards, thereby reducing compliance burdens and enhancing ease of business operations. The harmonization aims to deliver consistent labelling for medical devices, easing consumer understanding and providing transparent information specific to healthcare products.