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New Rules Change How Medical Devices Are Packaged
Summary: The Government has declared new packaging regulations for medical devices to align organically with the existing medical device standards.
The Government has made specific provisions in the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, in respect of the packaging of medical devices that align with the Medical Devices Rules, 2017.
The Consumer Affairs Ministry states that this change has been implemented to streamline regulations and increase consumer protection in the healthcare industry. Â
The amendmentÂ
- The amendment states that for packages that contain medical devices, the Medical Devices Rules, 2017, will prevail over general packaging norms, related to the height and width of the numerals and letters used in product declarations.
- Declarations related to the medical products are compulsory, but the font size and dimensions standards will now adhere to medical device-specific regulations instead of the general legal metrology standards.Â
- In addition, the provision of the relaxations to Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011, which exempts certain declarations, will no longer be applicable to medical devices.
- The exemptions under legal metrology will apply to non-medical products and not those products that fall under the specialised medical devices framework.
- The labelling shall be done as per the provisions of the Medical Devices Rules, 2017 and product declarations are not required on the principal display panel as mandated by the legal Metrology Rules.
- This uniform labelling will reduce the burden of compliance and make business easier. It will eliminate consumer confusion and display precise and accurate information about the healthcare products.
- This will benefit the legal metrology enforcement officers, with regard to jurisdiction, application, interpretation and compliance across the states and enforcement agencies. Â
- The Government has safeguarded the interests of the healthcare industry as well as simplified regulations to avoid confusion and ensure transparency.Â
Just move it!
Inputs from various media sources.
- Rupal Sonpal
- Blogs
- 14 November 2025
- 17:00








