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Medical device packs will have to display key info

All medical devices will have to bear details like retail price, country of origin, size and dimensions and consumer care details on the package so that consumers can make an informed decision, the department of consumer affairs has said.

In a letter to the department of pharmaceuticals (DOP), the department of consumer affairs has asked that medical devices are required to make these declarations in the interest of consumers.

According to the letter which calls for enforcement of provisions of the Legal Metrology Act, 2009 and the Legal Metrology (Packaged Commodities) Rules, 2011 on medical devices, the plain and conspicuous mandatory declarations are required under the rules in the interest of consumers, it said.

It also informed the department that it was mandatory under the provisions of Legal Metrology (Packaged Commodities) Rules, 2011 that every packaged commodity including the medical devices should bear such details on them or on a label securely affixed.

“The provisions require only the declaration of mandatory information including retail sales price in the form of MRP, country of origin, size and dimensions of the commodity where the sizes of the commodity in the package are relevant, unit sale price and consumer care details, on the pre-packaged commodities based on which the consumer can take an informed decision,” it said

The provisions are applicable on indigenously manufactured as well as imported medical devices.

Earlier the Association of Indian Medical Device Industry (AiMeD), Association of Diagnostic Manufacturers of India (ADMI), and Surgical Dressings Manufacturers Association of India (SDMAI) represented that the ministry of health and CDSCO can amend Drugs & Cosmetics Act & Medical Device Rules, 2012 to harmonise labelling requirements with packaged commodities rules.These associations had requested that enforcement of Legal Metrology (Packaged Commodities) Rules, 2011 and right to regulate by DoCA (department of consumer affairs) should continue to be maintained as consumer protection requirements (under Packaged Commodities Rules) are complementary to patient safety/protection requirements (under MDR) and one cannot always be substitute for the other.

The enforcement provisions are made under the Legal Metrology Act/ Packaged Commodities Rules for various offenses including selling over and above MRP in hospitals and retail premises or on ecommerce platforms, altering MRP or other declarations/ without declarations etc. to ensure the consumer rights.

“The provisions of the Legal Metrology Act are also applicable on sale of products in loose or without packaging and sale through ecommerce websites in the interest of consumers,” itsaid.

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