The Government of India has issued the Legal Metrology (Packaged Commodities – “LMPC”) Amendment Rules, 2025, a pivotal reform that exempts medical devices from the purview of the LMPC Rules, 2011. The amendment puts to rest long-standing issues of overlap created by the Medical Devices Rules, 2017, and is likely to ease the compliance burden of medical device manufacturers and importers.
The amendment provides that declarations and labeling requirements with regard to the packaging of a medical device will fall within the domain of the MDR, 2017. The revision further aligns font size and format to the MDR requirements.
This would considerably reduce the compliance burden and operational costs for industry players, since in the past, they had to comply with both sets of medical device regulatory frameworks. The streamlined requirements are expected to enhance legal transparency and create a more predictable environment for device approval and investment in India’s growing MedTech sector.
In addition, the move brings consistency and clarity to device labeling for consumers and healthcare product manufacturers with standardized information, including Unique Device Identifiers (UDIs), warnings, and expiration dates.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.