Labeling is one of the most frequently reviewed parts of any CDSCO submission. For a step-by-step breakdown of the entire import registration and approval pathway, visit our main guide on CDSCO import license and medical device registration in India. Global harmonization efforts, like those by the GHTF, recommend standardized labelling practices to simplify global distribution and usage. For medical device manufacturers and importers in India, ensuring precise and compliant labelling is essential for the safe and intended use of medical devices.
Contents of Labelling
India medical device labelling requirements include adding device name, manufacturer details, usage instructions, and safety warnings, as well as any specific handling or storage requirements. It must also contain technical details such as batch numbers or serial numbers to support traceability, as outlined in the SUGAM portal. The content of labelling is organized into three sections: General, Where Applicable, and Instructions, each addressing specific aspects necessary for clear, comprehensive information to ensure the device’s safe and effective use.
General:
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- Identification and Manufacturer Information: Labels should clearly display the name or trade name, and address of the manufacturer. For imported devices, also include the importer or authorized representative’s name and address within the importing country.
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- Device Details: Provide sufficient information for users to identify the device or contents of the packaging.
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- Tracking Information: Indicate batch codes, lot numbers, or serial numbers to facilitate device traceability and recall actions.
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- Usage Timeline: Clearly state the date until which the device may be safely used, expressed in year and month.
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- Manufacturing Date: For applicable devices, indicate the manufacturing date, potentially within the batch code or serial number.
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- Storage and Handling: Specify any special storage or handling conditions on the external packaging.
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- Safety Information: Include warnings, precautions, intended performance, and potential side effects.
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- Operational Assurance: Provide information necessary to verify correct installation and operation, including maintenance, component replacement, and calibration requirements.
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- Preparation Requirements: Detail any treatments or handling needed before use, such as sterilization or calibration.
Where Applicable:
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- Sterilization: If the device is sterile, include instructions for handling damaged sterile packaging and re-sterilization methods.
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- Usage Restrictions: Note if the device is for single use, custom-made for individual use, or intended for clinical investigations, demonstrations, or presentations.
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- Compatibility and Interference: Detail any necessary information to ensure safe installation with other devices and potential interference risks.
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- Reusability: For reusable devices, provide cleaning, disinfection, and sterilization instructions, including any reuse limitations.
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- Radiation Emission: If applicable, describe the nature, type, intensity, and distribution of any emitted radiation.
Instructions:
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- Device Performance: Outline precautions to be taken if there are changes in device performance.
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- Environmental Exposure: Advise on precautions against exposure to magnetic fields, electrical influences, electrostatic discharge, and other environmental factors.
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- Medicinal Interactions: Provide information on any medicinal products the device administers, including substance limitations.
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- Disposal Risks: Highlight any special risks associated with the device’s disposal.
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- Incorporated Substances: List any medicinal substances incorporated into the device.
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- Accuracy and Usage Requirements: Specify the accuracy of devices with measuring functions and any special facility, training, or qualifications needed by the device user.
Legal Metrology India medical device labelling requirements
In India, the labelling of medical devices is governed by: the Legal Metrology Act, 2009, and the Medical Devices Rules, 2017. These ensure that all medical devices are properly labeled with essential information to guarantee their safe and effective use.
Key Labelling Requirements as Per the Legal Metrology Act, 2009:
Label Content Requirements: Labels must include the manufacturer’s, packer’s, or importer’s name and address, the common or generic name of the product, net quantity, manufacturing or packaging date, and retail sale price.
Label Placement and Size: All required information should be visible on the principal display panel of the packaging, with specific requirements for the size of numerals and letters to ensure they are easily readable.
Additional Declarations: Labels must also provide details such as the dimensions of the product if they are relevant to the consumer’s use or the product’s price. The method of quantifying the product—whether by weight, volume, length, or number—must be appropriate and clear.
Special Labelling Provisions: There are detailed rules for commodities that require the declaration of volume or weight and for those that need to indicate dimensions or numbers. The label must give consumers a clear understanding of the product’s quantity and characteristics.
Principal Display Panel: Required information must be grouped together on the package’s principal display panel, ensuring it is easily accessible and comprehensible to consumers.
Consumer Contact Information: Every package must bear the name, address, telephone number, and email address (if available) of the person or office to be contacted in case of consumer complaints.
Prohibition on Sticker Use: It is not permissible to affix individual stickers on the package for altering or making declarations required under these rules, except for reducing the Maximum Retail Price (MRP). A sticker with the revised lower MRP may be affixed, provided it does not cover the original MRP declaration.
Handling Multi-Component Packages: For packages containing multiple components sold as a single commodity, the declaration required must appear on the main package. The main package must also carry information about the other accompanying packages, or this information can be provided on the individual packages with a note on the main package.
Expiry of Packaging Material: Any packaging material or wrapper that could not be exhausted by the manufacturer or packer may be used for packing material up to a specified date, after making necessary corrections required under these rules.
For any labelling-related violations, a general fine of two thousand rupees is imposed. These penalties emphasize the importance of adhering to labelling requirements to ensure transparency, consumer protection, and market fairness.
Additional Points Regarding India medical device labelling requirements from CDSCO:
Indelible Ink: Labels must be printed in indelible ink to ensure permanence.
Expiry and Shelf Life: The month and year of manufacture and expiry must be indicated, or the shelf life must be stated. For sterile devices, the date of sterilization may be used as the manufacturing date. Certain materials like stainless steel or titanium devices that are supplied non-sterile do not require an expiry date.
Batch/Lot Number: Labels must provide a distinctive batch or lot number.
Storage Conditions: Any special storage or handling conditions must be indicated.
Sterile State: If the device is supplied as sterile, its sterile state and sterilization method must be specified.
Warnings and Precautions: Any relevant warnings or precautions must be included to draw the user’s attention.
Single-Use Indication: Devices intended for single use must be labeled as such.
Free Samples: If a medical device is intended for distribution as a free sample to medical professionals, it must be labeled “Physician’s Sample—Not to be sold.”
Manufacturing License Number: For domestic devices, the manufacturing license number must be included.
Import Details: For imported devices, labels must include the import license number, the name and address of the importer, and the actual manufacturing premises.
Symbols: Internationally recognized symbols can be used in lieu of text, provided they are understood by the user.
Small Devices: Small-sized devices that cannot bear all information legibly should include essential information for product identification and safety.
Export Exemptions: Labels for exported devices should meet the specific requirements of the importing country but must still display the device name, batch/lot/serial number, expiry date, manufacturer’s name and address, and license number.
Unique Device Identification (UDI): From January 1, 2022, all approved medical devices must have a unique device identification, including both a device identifier and a production identifier.
Shelf Life Limits: The shelf life should not exceed 60 months, except where justified with evidence. Specific conditions apply to devices with shorter shelf lives regarding their import.
Labelling for Clinical Evaluation: Devices used for clinical investigation or performance evaluation must have labels indicating the product name, batch/lot number, date of manufacture, use-by date, storage conditions, and manufacturer’s details.
Conclusion:
In addition to these requirements, CDSCO’s Rule 109A (amendment to the Drugs and Cosmetics Rules, 1945) highlights a few specific labelling obligations. Labels must carry the words “FOR CLINICAL INVESTIGATION ONLY” if the device is intended for trials, or “Physician’s Sample—Not to be sold” if supplied free of cost to healthcare professionals. Where devices are custom-made for an individual patient based on a practitioner’s prescription, the label must clearly state “custom made device.” Furthermore, for certain stable non-sterile devices made of stainless steel or titanium, an expiry date is not mandatory. Imported devices must display the import license number, importer’s details, and manufacturing site address. Rule 109A also permits the use of symbols recognized by BIS or ISO in place of text, provided safety and understanding are not compromised.
In conclusion, the labelling requirements set forth by the Legal Metrology (Packaged Commodities) Rules, 2011, and the Medical Devices Rules, 2017, are essential in ensuring that medical devices meet the highest safety and performance standards in India. Accurate labeling is just one element of India’s broader registration framework. You can see how it connects to the full CDSCO import license process in our detailed registration guide for medical devices in India. Morulaa provides expert guidance and comprehensive services to ensure that your medical devices comply with all Indian requirements, minimizing the risk of penalties and supporting your commitment to deliver safe, effective, and high-quality medical products to the market. By leveraging Morulaa’s expertise, medical device companies can focus on innovation and growth, confident in their compliance and market readiness. To know more about how we can support you, Click Here or email us on [email protected]