Last Updated on December 31, 2023 by The Health Master
Key information of medical device pack
In a recent development, the Department of Consumer Affairs has issued a letter to the Department of Pharmaceuticals (DOP), stating that all medical devices must display important information on their packaging.
The aim is to empower consumers to make informed decisions by providing details such as retail price, country of origin, size and dimensions, and consumer care information.
Enforcing Legal Metrology Act and Packaged Commodities Rules
The letter highlights the need to enforce the provisions of the Legal Metrology Act, 2009, and the Legal Metrology (Packaged Commodities) Rules, 2011 for medical devices.
These rules mandate the inclusion of clear and visible declarations on the packaging for the benefit of consumers.
Mandatory Information on Packaging
According to the letter, the Legal Metrology (Packaged Commodities) Rules, 2011 require the following mandatory information to be provided on medical device packaging:
- Retail Sales Price (MRP)
- Country of Origin
- Size and Dimensions of the device (if applicable)
- Unit Sale Price
- Consumer Care Details
This information enables consumers to make informed decisions when purchasing medical devices.
Applicability to Domestic and Imported Devices
The provisions outlined in the letter apply to both domestically manufactured and imported medical devices. All devices, regardless of their origin, must comply with the mandatory declaration requirements.
Harmonizing Labeling Requirements
Earlier, industry associations, including the Association of Indian Medical Device Industry (AiMeD), Association of Diagnostic Manufacturers of India (ADMI), and Surgical Dressings Manufacturers Association of India (SDMAI), requested the Ministry of Health and the Central Drugs Standard Control Organization (CDSCO) to align the labeling requirements of medical devices with the Packaged Commodities Rules.
Consumer Protection and Patient Safety
The associations emphasized that consumer protection requirements under the Packaged Commodities Rules are complementary to patient safety and protection requirements under the Drugs & Cosmetics Act and Medical Device Rules.
They stated that the enforcement of the Legal Metrology (Packaged Commodities) Rules, 2011, and the authority of the Department of Consumer Affairs should be maintained.
Enforcement of Consumer Rights
The provisions of the Legal Metrology Act and the Packaged Commodities Rules empower the authorities to take action against various offenses, including selling products above the MRP, altering MRP or other declarations, and selling products without proper declarations. These measures are implemented to ensure consumer rights are protected.
Applicability to Loose Products and E-commerce Platforms
The letter also emphasizes that the provisions of the Legal Metrology Act extend to the sale of products without packaging and through e-commerce websites. This ensures that consumer interests are safeguarded across various sales channels.
Conclusion:
The Department of Consumer Affairs has called for mandatory details to be displayed on medical device packaging, including retail price, country of origin, size and dimensions, and consumer care information.
Compliance with the Legal Metrology Act and Packaged Commodities Rules is required to protect consumer rights and ensure transparency in the medical device market.
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