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Medical device labelling is integral to patient safety and effective healthcare delivery. As per Chapter VI of India’s Medical Device Rules 2017, medical device labels must provide essential information to facilitate proper identification, handling, and usage.
Key Labelling Requirements:
The regulations mandate including specific details on medical device labels:
Identification details like name, batch number, or serial number.
User-friendly information to help identify and understand device usage.
Manufacturer/importer name, address, and manufacturing premises.
Net quantity, weight, volume or units.
Manufacturing/import license number for all locally made/imported devices.
Month and year of manufacture, expiry or shelf life.
Any medicinal or biological substance present.
For sterile devices, date of sterilization or shelf life.
The words “Physician’s Sample- Not to be sold” for free samples.
Special storage or handling requirements.
Batch or lot number for traceability.
Sterile state and sterilization method.
Relevant warnings and precautions.
Single-use indication if applicable.
Labelling for Evaluation and Clinical Investigations:
Devices for clinical evaluation or investigation must also have appropriate labelling with details like name, batch number, manufacturing and expiry dates, storage conditions, manufacturer information, and intended purpose.
Additionally, labels must meet Legal Metrology (Packaged Commodities) Rules 2011 for packaging and labelling of commodities.
Conclusion:
Comprehensive medical device labelling enables informed clinical decisions, builds patient trust, and ensures seamless healthcare delivery. As technologies advance, robust labelling remains imperative for the highest standards of care. Medical device labels must adhere to MDR 2017 and Legal Metrology Rules for compliance.
With over 12 years of experience, Regulatory Solutions India provides end-to-end labelling compliance services. Contact us to elevate your regulatory compliance.
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