In a move aimed at supporting India’s fast-growing medical device industry, the Government of India has announced the alignment of packaging and labeling rules for medical devices, easing compliance requirements and promoting regulatory clarity for manufacturers.

The Department of Consumer Affairs, in coordination with the Central Drugs Standard Control Organisation (CDSCO), has revised the Legal Metrology (Packaged Commodities) Rules, 2011, to bring them in line with the Medical Device Rules (MDR), 2017. The reform is expected to reduce duplication of declarations and simplify regulatory processes for domestic and international medical device makers.

Under the new framework, medical device manufacturers will now be required to provide only essential declarations—such as product name, manufacturer details, manufacturing date, and expiry—thereby streamlining packaging requirements while maintaining patient safety and transparency.

The move follows consistent industry feedback highlighting the overlap between legal metrology and medical device regulations, which often resulted in compliance delays and increased operational costs.

A senior official from the Ministry of Health and Family Welfare said, “This alignment marks a significant step toward ease of doing business in the medical device sector. It will help streamline packaging declarations while ensuring product traceability and consumer protection.”

Industry experts have welcomed the reform, noting that it reflects the government’s broader commitment to Make in India, encouraging innovation and competitiveness in the domestic medtech sector.

The medical device industry, valued at over USD 12 billion, is one of India’s fastest-growing healthcare segments. The streamlined rules are expected to facilitate faster market access, promote regulatory harmonization, and enhance India’s positioning as a global manufacturing hub for medical devices