The Ministry of Consumer Affairs has published the Draft Legal Metrology (Packaged Commodities) Amendment Rules, 2025 (“Draft Amendment”) with a view to amend the existing Legal Metrology (Packaged Commodities) Rules, 2011 (“Rules”). The proposed amendments introduce specific provisions concerning the packaging and labelling of medical devices, ensuring alignment with the Medical Devices Rules, 2017. Comments and suggestions are invited from stakeholders, which may be e-mailed at: dirwm-ca@nic.in / ashutosh.agarwal13@nic.in / mk.naik72@gov.in before 12th March 2025.
Key Highlights:
- The principal display panel traditionally refers to the total surface area where information is grouped together or split between pre-printed and online information. It is proposed that provisions of Medical Devices Rules, 2017 shall apply to packages containing medical devices;
- The draft amendment proposes medical device packaging to adhere to specifications for the height and width of numerals and letters on the principal display panel outlined in the Medical Devices Rules, 2017, as opposed to the standard requirements prescribed in the existing rules;
- The Central Government may relax certain provisions of the rules temporarily for manufacturers or packers, provided corrective measures are specified. The draft amendment proposes this relaxation for medical devices, allowing it only for declarations that comply with these rules.
The Draft Amendment is linked below for your reference.
Source: Ministry of Consumer Affairs, Food and Public Distribution
