India Medical Device Local Labeling Requirements: Compliance Before Customs Clearance

India Medical Device Local Labeling Requirements

Medical device labeling in India is mandatory and primarily governed by Chapter VI of the Medical Devices Rules, 2017. For devices considered "packaged commodities," compliance with the Legal Metrology (Packaged Commodities) Rules, 2013 is also required.

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📝 India-Specific Labeling Details

While many international labeling requirements are accepted, several key pieces of information are unique to the Indian market and must be prominently displayed:

• Device Registration Number: The registration number issued by the CDSCO.
• Initial Importer Contact Specifics: Complete contact information for the initial importer or License Holder.
• Local Customer Contact: A local customer contact telephone number.
• Maximum Retail Price (MRP): The Manufacturer Suggested Maximum Retail Price, which is mandatory under the Legal Metrology Rules.
• Batch/Lot Number: Standard traceability information.

🛂 Compliance Before Customs Clearance

A critical requirement is that all India-specific labeling must be affixed to the medical device packaging prior to clearance by the Indian Customs office.

• Change in Practice: While Customs previously accepted a Letter of Guarantee (LG) allowing labeling post-clearance, this practice is now considered unreliable. To ensure smooth and timely market access, foreign manufacturers must ensure their devices are labeled correctly before the shipment arrives at Customs.
• Customs Sequestration: If a shipment is sequestered (held) at Customs due to labeling issues, local labeling services can sometimes be utilized, but only if customs duties have not yet been paid.

💻 Instructions for Use (IFU)

As per notification G.S.R. 30 (effective January 15, 2019), the CDSCO formally accepts Electronic Instructions for Use (eIFUs). This allows the Instructions for Use to be provided in an electronic format downloadable from the internet, rather than requiring a physical insert, which helps reduce costs and environmental impact.