Labelling plays a critical role in the regulatory oversight and safe use of medical devices. In India, medical device labelling is governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017, and the Legal Metrology (Packaged Commodities) Rules, 2011. These regulations aim to ensure that healthcare professionals and consumers receive clear, comprehensive, and accurate information about the medical device.
Manufacturers and importers must ensure that their labelling practices not only comply with Indian laws but also align with global standards such as those proposed by the Global Harmonization Task Force (GHTF), thereby supporting international trade and harmonized regulatory practices.
Regulatory Frameworks Governing Medical Device Labelling in India
India’s labelling requirements for medical devices are primarily defined under two legal frameworks:
1. Legal Metrology Act, 2009
This Act enforces uniformity in weights and measurements across packaged commodities, including medical devices. As per this law, medical devices marketed as packaged products must include essential details such as the manufacturer’s name and address, net quantity, maximum retail price (MRP), and other consumer-centric information. These labelling norms are designed to enhance transparency and uphold consumer rights.
2. Medical Devices Rules, 2017
Notified under the Drugs and Cosmetics Act, 1940, these rules specifically govern the classification, registration, and labelling of medical devices in India. The rules ensure that all medical devices in the Indian market meet prescribed safety, quality, and performance standards.
Mandatory Elements in Medical Device Labelling
Labelling of medical devices in India must include structured and standardized information to guide identification, handling, usage, and storage. The following categories highlight key labelling elements:
1. Device Identification and Manufacturer Details
Every label must prominently display the trade name or common name of the medical device along with the full name and address of the manufacturer. For imported devices, details of the Indian importer or authorized representative must also be included for traceability and accountability.
2. Product Description
The label should provide a clear description of the device, including its intended use, which allows users to distinguish it from similar devices on the market.
3. Batch or Serial Tracking Information
To enable effective traceability, each unit must carry batch numbers, lot numbers, or serial numbers. This is essential for quality control, inventory management, and effective recall, if required.
4. Manufacturing and Expiry Dates
Labels must indicate both the date of manufacture and either an explicit expiration date or the time period during which the device is considered safe and effective. The expiry should be shown as “MM/YYYY”.
5. Storage and Handling Instructions
Devices must carry instructions related to storage conditions such as required temperature ranges, humidity control, and protection from light. This ensures that the device remains functional until its intended use.
6. Safety Warnings and Precautions
Labels must list any warnings, side effects, or precautions users should be aware of, particularly for devices that could pose health risks if used improperly.
7. Maintenance and Operational Instructions
For devices requiring regular maintenance or calibration, the label should include operational guidance to ensure consistent performance and safety over its lifecycle.
8. Pre-use Preparations
If the device must undergo sterilization, calibration, or any form of pre-use processing, this requirement must be clearly stated on the label to inform the end user.
Where Do Medical Device Labelling Requirements Apply?
Beyond basic product details, medical device labelling in India must also address several specific conditions and operational factors. These additional labelling elements help ensure safe use, especially in specialized or high-risk contexts:
1. Sterilization Instructions
If the device is supplied in a sterile condition, the label must include clear instructions for handling. It should also mention precautions if the sterile packaging is compromised and provide re-sterilization methods, if applicable. This ensures sterility is maintained until the point of use.
2. Usage Limitations
Devices intended for single-use must have that clearly stated on the label to avoid reuse-related risks. Similarly, custom-made devices, investigational devices, or those for demonstration purposes must carry relevant disclaimers or labelling statements to restrict their use accordingly.
3. Device Compatibility and Interference
Labels must specify whether the device is compatible with other equipment and identify any potential risks related to electromagnetic or mechanical interference. For instance, if a device should not be used near MRI machines or radio-frequency emitting equipment, such warnings must be clearly highlighted.
4. Reusability Guidance
Reusable devices should be labelled with comprehensive cleaning, disinfection, and sterilization procedures. Additionally, the label must state the maximum number of reuse cycles to ensure both effectiveness and user safety are maintained.
5. Radiation Emission Details
If the device emits radiation, the labelling must specify the type, nature, strength, and distribution of the radiation. This information is critical for user safety, especially in clinical environments where radiation exposure must be controlled.
Mandatory Usage and Safety Instructions
To ensure proper use and prevent hazards, the following instruction-based elements must be included on medical device labels:
1. Device Performance Monitoring
The label must guide users on how to monitor the device’s performance and identify signs of malfunction. It should also recommend corrective steps to be taken in the event of performance degradation or unexpected behavior.
2. Environmental Safety Precautions
Medical devices may be sensitive to environmental factors such as magnetic fields, static electricity, humidity, or temperature variations. Labels must include instructions or warnings related to such exposures to prevent operational failures.
3. Interaction with Medicinal Substances
If a device is intended to administer or interact with medicinal products, its label must clearly describe the medication involved, its dosage, and any relevant contraindications or usage restrictions.
4. Safe Disposal Instructions
Post-use disposal instructions must be clearly outlined to prevent risks to human health or the environment. This is especially important for devices containing biohazardous, radioactive, or chemically reactive materials.
5. Embedded Substances and Material Disclosure
If the device incorporates any medicinal agents, antimicrobial coatings, or other biologically active materials, the label must disclose these components along with associated safety and usage guidelines.
6. Measurement Accuracy and Usage Requirements
For devices that perform measurement functions (e.g., thermometers, blood pressure monitors), the labelling must define accuracy limits and tolerances. If specialized training, infrastructure, or clinical expertise is required to operate the device safely and effectively, this must also be disclosed on the label.
Additional CDSCO Labelling Guidelines under the Medical Devices Rules, 2017
Medical device labelling in India must strictly adhere to the specifications laid out by the Central Drugs Standard Control Organization (CDSCO). These supplementary guidelines ensure product safety, user clarity, and regulatory accountability.
1. Use of Indelible Ink
All printed label information must be in indelible ink to avoid tampering and ensure durability throughout the device’s shelf life.
2. Shelf Life and Expiry Date
Manufacturers must indicate both the date of manufacture and the expiry date. For sterile devices, the sterilization date may act as the manufacturing date. However, non-sterile devices made of materials like stainless steel or titanium may be exempt from the expiry date requirement.
3. Batch and Lot Numbers
Each unit must bear a unique batch, lot, or serial number for traceability. This supports effective recall management and post-market surveillance.
4. Storage Instructions
If a product requires special storage conditions—such as temperature control, refrigeration, or protection from light—it must be explicitly stated on the label.
5. Sterility and Sterilization Method
Sterile devices must clearly state their sterile condition and the method of sterilization used (e.g., gamma radiation, EO gas, or autoclaving).
6. Warnings and Precautions
Labels must present all necessary safety warnings and usage precautions to minimize risk during use.
7. Single-Use Devices
For single-use products, statements like “Single Use Only” or “Do Not Reuse” must be prominently displayed.
8. Physician’s Samples
Devices provided as free samples should be labelled with “Physician’s Sample – Not to be Sold” to prevent commercial misuse.
9. License Information
- For domestically manufactured devices, the manufacturing license number is mandatory.
- For imported devices, the label must include the import license number, details of the importer, and the foreign manufacturer’s name and address.
10. Use of Symbols
Internationally recognized pictograms or symbols may replace text where appropriate—provided they are universally understood by the intended users, improving multilingual accessibility.
11. Labelling on Small Devices
For compact devices with limited space, essential identifiers such as the product name and batch number should appear directly on the device, with full labelling details provided on the outer packaging.
12. Export Packaging
Medical devices meant for export must comply with the destination country’s labelling rules, but must still display critical information including:
- Device name
- Manufacturer’s details
- License number
- Batch/lot number
- Expiry date
13. Unique Device Identification (UDI)
Effective from January 1, 2022, all registered medical devices in India are required to bear a UDI, consisting of:
- A Device Identifier (DI) — unique to the product
- A Production Identifier (PI) — providing manufacturing and batch information
This enhances traceability and helps in effective post-market surveillance.
14. Shelf Life Limitation
Medical devices should not typically have a shelf life exceeding 60 months, unless such duration is scientifically justified. Devices with shorter shelf lives may face additional regulatory scrutiny during import.
15. Labelling for Clinical Trial Devices
Devices used for clinical investigations or performance evaluation must include specific data such as:
- Device name
- Lot/batch number
- Manufacturing and expiry dates
- Storage conditions
- Manufacturer’s identity
Labelling Requirements under the Legal Metrology Act, 2009
The Legal Metrology (Packaged Commodities) Rules, 2011, enforced under the Legal Metrology Act, 2009, govern labelling standards for packaged medical devices from a consumer protection standpoint.
1. Principal Display Panel
All key declarations must appear on the principal display panel of the packaging for easy visibility and consumer understanding.
2. Mandatory Declarations
Medical device labels must include:
- Name and address of the manufacturer, packer, or importer
- Generic or common name of the product
- Net quantity
- Manufacturing/packaging date
- Maximum Retail Price (MRP)
3. Font and Clarity
All text and numerals on the label must meet minimum size requirements and be legible to ensure clarity and consumer readability.
4. Consumer Support Details
Manufacturers must include contact information such as:
- Postal address
- Telephone number
- Email ID
These help consumers raise concerns or complaints regarding the product.
5. Sticker Usage Restrictions
Using stickers to change mandatory declarations (except for MRP reduction) is prohibited. Even in such cases, stickers must not obscure original information.
6. Handling Multi-Component Packages
If multiple items are sold as a unit:
- Either the outer package should carry full declarations, or
- Each individual inner component must be properly labelled, with the outer pack mentioning that such details are inside.
7. Use of Old Packaging
Manufacturers may temporarily use older packaging materials by updating the label to reflect new compliance requirements, but only within approved transitional timelines.
8. Penalties for Non-Compliance
Failure to meet labelling rules under the Legal Metrology framework may result in a penalty, reinforcing the need for transparency and strict adherence.
