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Core Purpose

The Central Government issues new rules to further amend the Legal Metrology (Packaged Commodities) Rules, 2011, specifically regarding declarations for medical devices.

Detailed Summary

The Ministry of Consumer Affairs, Food and Public Distribution (Department of Consumer Affairs) published Notification G.S.R. 778(E) on October 23, 2025, exercising powers under clauses (j) and (q) of sub-section (2) of section 52 of the Legal Metrology Act, 2009 (1 of 2010). These rules, titled the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, further amend the Legal Metrology (Packaged Commodities) Rules, 2011, and come into force upon publication in the official gazette. Key amendments introduce provisos across rules 2(h), 7(2), and 7(3) of the principal rules, stipulating that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017, shall apply for making declarations, as well as for the height and width of numerals and letters in such declarations. Furthermore, rule 33 of the principal rules is renumbered as sub-rule (1), and a new sub-rule (2) is inserted, clarifying that relaxations under rule 33 will not apply where the Medical Devices Rules, 2017, are applicable. The principal rules were originally published vide G.S.R. 202(E) dated March 7, 2011, and last amended vide G.S.R. 722(E) dated October 6, 2023.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-24102025-267107 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 694] NEW DELHI, FRIDAY, OCTOBER 24, 2025/KARTIKA 2, 1947 MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION (Department of Consumer Affairs) NOTIFICATION New Delhi, the 23rd October, 2025. G.S.R. . 778(E).—In exercise of the powers conferred by (j) and (q) of sub-section (2) of section 52 of the Legal Metrology Act, 2009 (1 of 2010), the Central Government hereby makes the following rules further to amend the Legal Metrology (Packaged Commodities) Rules, 2011, namely:- 1. Short title and commencement. - (1) These rules may be called the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. (2) They shall come into force on the date of their publication in the official gazette. 2. In the Legal Metrology (Packaged Commodities) Rules, 2011 (hereinafter referred to as the principal rules), in rule 2, to clause (h), the following proviso shall be inserted, namely:- "Provided that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017, shall apply to make declarations;". 3. In the principal rules, in rule 7,- (i) in sub-rule (2), the following proviso shall be inserted at the end, namely:- "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."; (ii) to sub-rule (3), the following proviso shall be inserted at the end, namely:- "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.". 4. In the principal rules, rule 33 shall be numbered as sub-rule (1) and after the rules as so number, the following sub-rule shall be inserted, namely:- "(2) In case where the Medical Devices Rules, 2017 are applicable, the relaxation given under this rule shall not apply.". [F. No. I-19/33/2022-W&M] ANUPAM MISHRA, Jt. Secy. Note: The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R. 202(E), dated the 7th March, 2011 and was last amended vide number G.S.R. 722(E), dated 6th October, 2023. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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