Government eases packaging compliance burden for medical devices

The amendment introduces specific provisions for packages containing medical devices, aligning the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017. The move aims to ensure regulatory harmony, reduce compliance ambiguity, and strengthen consumer protection within the healthcare sector.

Under the amendment, in the case of packages containing medical devices, the provisions of the Medical Devices Rules, 2017 will prevail for the height and width of numerals and letters used in product declarations. While the requirement for mandatory declarations remains in force, the dimensional and font size standards will now follow those prescribed under the Medical Devices Rules instead of the general Legal Metrology standards.

The amendment also clarifies that the relaxation provided under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011 — which allows certain exemptions in declarations — will not apply where the Medical Devices Rules, 2017 are in effect. This ensures that exemptions under Legal Metrology are limited to non-medical products.

In addition, the requirement to make declarations on the Principal Display Panel, as mandated under the Legal Metrology (Packaged Commodities) Rules, will not be compulsory for medical devices. Instead, such declarations may be made in accordance with the Medical Devices Rules, 2017.

According to the ministry, this amendment will provide consumers with a single, consistent labelling framework for medical devices, ensuring clear, accurate, and uniform information specifically designed for healthcare products. It is also expected to strengthen consumer protection by eliminating overlaps between the two regulatory systems.

For industry stakeholders, the change offers greater clarity and predictability by removing duplication between regulatory frameworks. The amendment reduces compliance burden by requiring adherence to a single set of labelling standards, thereby supporting the government’s Ease of Doing Business initiative.

The clarification will also assist Legal Metrology enforcement officers by establishing clearly defined jurisdiction and applicability, promoting uniform interpretation and compliance across states.

The government said the harmonisation reflects its continued commitment to fostering a business-friendly regulatory environment while maintaining robust consumer safeguards in the healthcare domain. Aligning the Legal Metrology Rules with the Medical Devices Rules advances India’s Ease of Living and Ease of Doing Business objectives, providing both industry clarity and consumer confidence.

Full press release here.