Government Notification on Legal Metrology Amendments
These changes aim to streamline compliance for manufacturers and ensure consistency in labeling and declaration standards across regulated sectors. The amendments were made under sections (j) and (q) of sub-section (2) of section 52 of the Legal Metrology Act, 2009.
Key Changes to the Rules
Amendment to Rule 2: Declarations for Medical Devices
A new proviso has been added to clause (h) of Rule 2, stating: “Provided that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017, shall apply to make declarations.” This ensures that medical device packaging follows specialized guidelines for accurate and compliant labeling.
Updates to Rule 7: Font Size and Dimensions
Rule 7 has been revised with two new provisos in sub-rule (2) and sub-rule (3):
- Sub-rule (2): “Provided that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017, shall apply for the height of any numeral and letter to make declarations.”
- Sub-rule (3): “Provided that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017, shall apply for the width of any numeral and letter to make declarations.”
These adjustments prioritize readability and regulatory alignment for health-related products.
Revision to Rule 33: Relaxation Provisions
Rule 33 is now sub-rule (1), with a new sub-rule (2) inserted: “(2) In case where the Medical Devices Rules, 2017 are applicable, the relaxation given under this rule shall not apply.” This eliminates relaxations for medical device packages to uphold stricter standards.
Implementation and Background
The Legal Metrology (Packaged Commodities) Amendment Rules, 2025 come into force on the date of publication. The principal rules were originally published on March 7, 2011 (G.S.R. 202(E)), and last amended on October 6, 2023 (G.S.R. 722(E)).
This notification, signed by Joint Secretary Anupam Mishra (File No. I-19/33/2022-W&M), reflects ongoing efforts to harmonize consumer protection laws with evolving medical regulations.