Operon Strategist stays on top of the latest developments in medical devices. Sharing another important and recent update: The Department of Consumer Affairs has sent a letter to the Department of Pharmaceuticals (DOP) requesting that medical devices must include key details on the package.
“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 said in the letter.
This is in accordance with the Legal Metrology (Packaged Commodities) Rules, 2011 which states that it is mandatory that every packaged commodity including medical devices should bear such details on them or on a label securely attached.
The Department of consumer affairs also mentioned: “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.”
As a medical device consultant, We can assist manufacturers and distributors in complying with these new requirements. Our service can provide guidance on updated Medical device packaging designs to include the necessary information, ensuring adherence to the Legal Metrology (Packaged Commodities) Rules, and facilitating communication with the Department of Consumer Affairs.
These enforcement provisions are made under the Legal Metrology Act/Packaged Commodities Rules in order to protect consumer rights and to prevent various offenses, such as selling above MRP in hospitals, retail locations, or on e-commerce platforms, altering MRP or other declarations/without declarations, etc.
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 could amend the Drugs & Cosmetics Act & Medical Device Rules, 2012 to harmonize labelling requirements with packaged commodities rules.
Contact us today, you can directory call on 93702a83428 or WhatsApp us to discuss how our consultancy services can help your medical device business navigate regulatory changes, maintain compliance, and meet consumer expectations. Together, we can ensure your medical device packaging has done appropriately, empowering consumers to make well-informed decisions while upholding industry standards.
