Medical Device Labeling Requirements in India

Labeling for medical devices in India is very important for ensuring safety and compliance with regulatory standards set by CDSCO (Central Drugs Standard Control Organization). Global harmonization efforts, like those by the GHTF, recommend standardized labeling practices to simplify global distribution and usage. For medical device manufacturers and importers in India, ensuring precise and compliant labeling is not just about adhering to regulations like MD-14 but is essential for the safe and intended use of medical devices.

Contents of Labeling

Regulatory compliance to be followed by medical device manufacturers for India 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 labeling 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:

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.
Device Details: Provide sufficient information for users to identify the device or contents of the packaging.
Tracking Information: Indicate batch codes, lot numbers, or serial numbers to facilitate device traceability and recall actions.
Usage Timeline: Clearly state the date until which the device may be safely used, expressed in year and month.
Manufacturing Date: For applicable devices, indicate the manufacturing date, potentially within the batch code or serial number.
Storage and Handling: Specify any special storage or handling conditions on the external packaging.
Safety Information: Include warnings, precautions, intended performance, and potential side effects.
Operational Assurance: Provide information necessary to verify correct installation and operation, including maintenance, component replacement, and calibration requirements.
Preparation Requirements: Detail any treatments or handling needed before use, such as sterilization or calibration.

Where Applicable:

Sterilization: If the device is sterile, include instructions for handling damaged sterile packaging and re-sterilization methods.
Usage Restrictions: Note if the device is for single use, custom-made for individual use, or intended for clinical investigations, demonstrations, or presentations.
Compatibility and Interference: Detail any necessary information to ensure safe installation with other devices and potential interference risks.
Reusability: For reusable devices, provide cleaning, disinfection, and sterilization instructions, including any reuse limitations.
Radiation Emission: If applicable, describe the nature, type, intensity, and distribution of any emitted radiation.

Instructions:

Device Performance: Outline precautions to be taken if there are changes in device performance.
Environmental Exposure: Advise on precautions against exposure to magnetic fields, electrical influences, electrostatic discharge, and other environmental factors.
Medicinal Interactions: Provide information on any medicinal products the device administers, including substance limitations.
Disposal Risks: Highlight any special risks associated with the device’s disposal.
Incorporated Substances: List any medicinal substances incorporated into the device.
Accuracy and Usage Requirements: Specify the accuracy of devices with measuring functions and any special facility, training, or qualifications needed by the device user.

Introduction to Regulatory Frameworks in India:

In India, the labeling of medical devices is governed by two primary sets of regulations: the Legal Metrology Act, 2009, and the Medical Devices Rules, 2017. These regulations ensure that all medical devices are properly labeled with essential information to guarantee their safe and effective use.

Legal Metrology Act, 2009: This act focuses on standardizing weights and measures and ensuring that packaged commodities, including medical devices, are labeled with accurate and clear information. The aim is to protect consumer interests and ensure fair trade practices by providing transparency about the product’s quantity, price, and other critical details.

Medical Devices Rules, 2017: These rules were established under the Drugs and Cosmetics Act, 1940, to specifically address the regulatory needs of the medical devices sector. They cover various aspects of medical device regulation, including classification, registration, quality management, and labeling. The goal is to ensure that medical devices meet stringent safety, efficacy, and quality standards, thereby protecting public health and safety.

Key Labeling 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 Labeling 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 labeling-related violations, a general fine of two thousand rupees is imposed. These penalties emphasize the importance of adhering to labeling regulations to ensure transparency, consumer protection, and market fairness.

Additional Points from Medical Devices Rules, 2017:

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.
Labeling 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 conclusion, the labeling 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. Morulaa provides expert guidance and comprehensive services to ensure that your medical devices comply with all Indian regulatory 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].