India, October 25, 2025 — In a significant regulatory update, the Ministry of Consumer Affairs, Food and Public Distribution has issued a Gazette notification on October 24, 2025, announcing the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. This amendment brings much-needed clarity and alignment between India’s packaging regulations and the Medical Devices Rules (MDR), 2017.
Effective Date and Implementation Details
- The document is called the Legal Metrology (Packaged Commodities) Amendment Rules, 2025.
- It comes into force immediately — i.e., from the date it is published in the Gazette (October 24, 2025).
LMPC Rules: Overview of the Regulatory Changes
The amendment explicitly states that medical devices will now be governed by the labeling and declaration provisions under MDR 2017, rather than the Legal Metrology (Packaged Commodities) Rules, 2011 (LMPC Rules). This marks the end of dual compliance for medical device manufacturers, who previously had to adhere to both sets of regulations for packaging and labeling.
Details of the Amendment
The changes affect Rule 2, Rule 7, and Rule 33 of the LMPC Rules:
Rule 2 (Definitions)
- Added a provision stating that for packages containing medical devices, the labeling/declaration rules under MDR 2017 apply instead of LMPC.
Rule 7 (Declarations on Packages)
- Sub-rule (2): Height of numerals and letters — for medical devices, MDR 2017 governs.
- Sub-rule (3): Width of numerals and letters — for medical devices, MDR 2017 governs.
Rule 33 (Relaxations under LMPC Rules)
- Now states that if MDR 2017 applies, any relaxations allowed under LMPC do not apply to medical devices.
Why LMPC Rules Matter
Previously, medical devices were treated like any other packaged product, meaning LMPC rules applied to them.
However, the 2025 amendment now clarifies that:
- For medical devices, labeling and declaration requirements are governed only by the Medical Devices Rules, 2017 (MDR).
- LMPC requirements no longer apply, except where MDR doesn’t cover a specific aspect.
So, LMPC still matters for non-medical packaged goods, but for medical devices, MDR takes precedence.
Summary of the Amendment
This amendment clearly separates medical devices from general packaged commodities under the Legal Metrology framework.
From now on:
Labeling declarations → governed only by MDR 2017.
Font size and presentation → governed only by MDR 2017.
LMPC exemptions → not available for medical devices.