Medical device packs should display important information, health news, ET HealthWorld

Medical device packs should display important information, health news, ET HealthWorld


The Department of Consumer Affairs requires all medical devices to carry details such as retail price, country of origin, size and dimensions, and consumer care details on the packaging so that consumers can make an informed decision. said there is.

In a letter to the pharmacy department (DOPs), the Department of Consumer Affairs has asked medical devices to make these declarations for the benefit of consumers.

According to a letter calling for the enforcement of the provisions of Legal metrology law2009 and the Legal Metrology (Packaged Goods) Regulations 2011 for Medical Devices, said that clear, conspicuous and obligatory declarations are required under the Regulations for the benefit of consumers.

Under the provisions of the Legal Metrology (Prepackaged Goods) Regulations 2011, all prepackaged goods, including medical devices, must carry such details or be securely labeled, the ministry said. was notified.

‚ÄúThis provision only requires the declaration of essential information, including retail price in MRP format, country of origin, size and dimensions of the goods in relation to the size of the goods in the package, unit selling price and details of consumer care. It’s about prepackaged goods that consumers can make informed decisions about.”

This provision applies to both domestically manufactured and imported medical devices.

Formerly the Indian Association Medical equipment Industry (AiMeD), Diagnostic Manufacturers Association of India (ADMI) and Surgical Bandage Manufacturers Association of India (SDMAI) Ministry of Public Health CDSCO could amend the Pharmaceuticals and Cosmetics Act 2012 and the Medical Devices Regulations to harmonize labeling requirements. Rules for packaged goods.

These groups called for the implementation of the Legal Metrology Act (Packaged Goods) Regulations 2011 and continued maintenance of regulatory rights by the DoCA (Department of Consumer Affairs) as a consumer protection requirement. Rules for packaged goods) complements patient safety/protection requirements (based on MDRMore), one does not always take the place of the other.

Based on the Law of Legal Measurement/Prepackaged Goods Regulations, in order to ensure the rights of consumers, various measures such as sales above MRP in hospitals and retail stores, e-commerce platforms, change/no declaration of MRP and other declarations, etc. Enforcement regulations are set for crimes.

“The provisions of the Legal Metrology Act also apply to the sale of unpackaged or unpackaged products and through e-commerce websites for the benefit of consumers,” the paper said.

  • Published May 26, 2023 at 1:11 AM IST

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