The Ministry of Consumer Affairs releases amendment in LM Packaged Commodities Rules, which shall come in force on 23rd Oct, 2025. The amendments state that upon publication in the Official Gazette, packages containing medical devices must follow the Medical Devices Rules, 2017 for declarations, font size, and character width. Exemptions under Rule 33 of the Legal Metrology Rules will not apply to such packages, ensuring medical devices comply with Medical Device Rules, 2017.
The Ministry of Consumer Affairs releases amendment in Legal Metrology Packaged Commodities Rules.
• In the Legal Metrology (Packaged Commodities) Rules, 2011, in rule 2, to clause (h), the following proviso shall be inserted,
‘Provided that for packages containing medical devices, the provisions of the Medical Devices Rules, 2017, shall apply to make declarations’
• In the principal rules, in rule 7, in sub-rule (2), the following proviso shall be inserted
‘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.’
• In Rule 7, to sub-rule (3), the following proviso shall be inserted
‘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.’
• Rule 33 will become sub-rule (1), and a new sub-rule will be added after it as
‘(2) In case where the Medical Devices Rules, 2017 are applicable, the relaxation given under this rule shall not apply.’