Medical Device Labelling Requirements in India

Medical Device Labelling Requirements in India. Introduction to Medical Device Labelling Requirements in India Medical device labelling is an important aspect of ensuring both regulatory compliance and user safety. In India, the labelling of medical devices is governed primarily by the Central Drugs Standard Control Organization (CDSCO), under the Medical Devices Rules, 2017, and the Legal Metrology (Packaged Commodities) Rules, 2011. These rules are intended to provide consumers and healthcare professionals with accurate, comprehensive, and accessible information about the medical device. Manufacturers and importers must align their labelling practices not only to meet local legal requirements but also to support global harmonization efforts guided by international groups like the Global Harmonization Task Force (GHTF).
Regulatory Frameworks Governing Medical Device Labelling in India
There are two main sets of regulations that medical device companies must comply with for labelling their products in India:
Legal Metrology Act, 2009
The Legal Metrology Act, 2009, ensures standardization in weights and measures and governs the labelling requirements for packaged commodities. Medical devices, when sold as packaged commodities, must carry essential declarations such as the manufacturer’s details, product quantity, pricing, and other consumer-relevant information. This ensures transparency, consumer protection, and fair trade practices.
Medical Devices Rules, 2017
Formulated under the Drugs and Cosmetics Act, 1940, these rules are dedicated specifically to medical devices. The Medical Devices Rules, 2017, detail requirements regarding classification, registration, quality management, and especially labelling. These rules aim to ensure that medical devices available in the Indian market meet necessary safety and performance standards.
Contents of Medical Device Labelling
The labelling of medical devices in India must include detailed and standardized information that helps in identifying, handling, storing, and using the device appropriately. These labelling contents are grouped into three major categories:
General
1. Requirements Identification and Manufacturer Information
Each label must clearly state the name or trade name of the device along with the name and address of the manufacturer. For imported devices, the name and address of the authorized representative or importer in India must also be included. This ensures traceability and helps regulators or users to quickly reach the manufacturer in case of queries or complaints.
2. Device Details 
Labels must provide enough information for users to understand what the device is and what it contains. This includes the common name of the device and a description that can help distinguish it from other similar products.
3. Tracking Information 
Medical devices must carry batch numbers, lot numbers, or serial numbers. This information is vital for traceability and is used when recalls or quality control actions are necessary. It ensures that any faulty or compromised device can be quickly identified and addressed.
4. Usage Timeline and Manufacturing Date 
Labels must clearly state the expiration date or the period until which the device can be used safely. This date should be expressed as a combination of the month and year. In addition, the manufacturing date must be included, either explicitly or embedded within the batch number or serial code. 
5. Storage and Handling Instructions 
Proper storage and handling are important to maintain a device’s efficacy and safety. Labels must specify any conditions that need to be maintained, such as temperature range, humidity, or protection from light. This information helps users store the product correctly until use.
6. Safety Information 
Each label must include safety-related details such as warnings, potential side effects, and precautions. These elements are vital to inform the user about any risk factors or necessary protective measures while using the device.
7. Operational Assurance 
To ensure correct installation and operation, labels must include essential maintenance instructions. This may involve component replacement or calibration needs to ensure that the device performs as intended throughout its lifecycle.
8. Preparation Requirements 
For certain devices, specific pre-use preparations may be required. For example, if the device needs sterilization or calibration before use, this information must be clearly stated on the label.
Where is it applicable?
1. Sterilization Instructions 
If the device is supplied sterile, it must include handling instructions, especially what to do if the sterile packaging is damaged. Methods for re-sterilization should be included, if applicable.
2. Usage Restrictions 
If a device is for single use only, it must be prominently mentioned on the label. Similarly, custom-made devices, devices for clinical investigations, or those intended only for demonstrations must carry appropriate labelling statements.
3. Compatibility and Interference 
Labels must indicate compatibility with other devices and highlight any potential interference risks. For example, electromagnetic interference risks should be noted if the device is used near MRI machines or other electronic devices.
4. Reusability 
Reusable devices should come with detailed cleaning, disinfection, and sterilization procedures. The label must also mention how many times the device can be reused safely.
5. Radiation Emission 
If the device emits any kind of radiation, the nature, type, intensity, and distribution of the radiation must be clearly described on the label. This helps users take necessary precautions.
Instructions
1. Device Performance 
Monitoring Instructions must explain how to monitor changes in device performance. If any sign indicates that the device is malfunctioning, users should know what action to take.
2. Environmental Exposure 
Labels should include precautions against magnetic fields, electrical interferences, and other environmental conditions that may affect the device’s functionality.
3. Medicinal Interactions 
If the device administers any medicinal substance, the label must include information about the medicine, its quantity, and any usage restrictions.
4. Disposal Risks 
Proper disposal is essential to avoid harm to health or the environment. Labels must include guidelines on how to safely dispose of the device after use.
5. Incorporated Substances 
If the device includes any medicinal substances or other materials, they must be listed along with any usage limitations.
6. Accuracy and Usage Requirements 
Devices with measuring functions must specify their accuracy limits. Moreover, labels should mention if any special training, qualifications, or facilities are required for correct usage.
Additional CDSCO Guidelines from Medical Devices Rules, 2017
The following are some additional CDSCO guidelines from Medical Devices Rules, 2017:
Indelible Ink
Requirement All labelling information must be printed using indelible ink to prevent tampering and ensure durability throughout the device's shelf life.
Shelf Life and Expiry
Medical devices must display both the date of manufacture and the date of expiry. For devices that are sterile, the date of sterilization may serve as the manufacturing date. In certain cases like stainless steel or titanium non-sterile devices, expiry dates may not be required.
Batch/Lot Numbers
Each device must carry a unique batch or lot number to maintain accountability and support any future corrective actions.
Storage Conditions
Any special requirements for storage, such as refrigeration or light-sensitive handling, must be noted on the label to ensure product stability.
Sterile State and Sterilization Method
If the device is sterile, the label must indicate its sterile state and specify the method of sterilization, whether it be EO gas, gamma radiation, or steam.
Warnings and Precautions
All necessary warnings and precautions, especially those pertaining to safe usage, must be highlighted clearly on the label.
Single-Use Indication
Devices that are meant for single use must be labeled with statements like "Single Use Only" or "Do Not Reuse."
Labelling of Physician Samples
Medical devices provided as free samples must be labeled as "Physician’s Sample—Not to be sold."
License Information
For domestic devices, the manufacturing license number must be mentioned. For imported devices, the import license number, name and address of the importer, and the overseas manufacturing facility must be included.
Use of Symbols
Internationally accepted symbols can replace text if they are universally understood by the intended users. This allows for multilingual accessibility.
Labelling for Small Devices
In cases where the device is too small to carry all the required information, only essential information such as product name and batch number should be included on the device, with full details on the outer package.
Export Labelling
Devices intended for export must comply with the labelling requirements of the importing country. However, Indian regulations still require labelling of critical elements such as device name, manufacturer details, lot/batch/serial number, expiry date, and license number.
UDI (Unique Device Identification)
Compliance As of January 1, 2022, all registered medical devices in India must carry a Unique Device Identifier (UDI). This includes a Device Identifier (DI) specific to the product and a Production Identifier (PI) that provides traceability.
Shelf Life Restrictions
In general, medical devices should not have a shelf life exceeding 60 months unless justified with evidence. Shorter shelf-life devices may have additional import requirements.
Labelling for Clinical Evaluation Devices
For devices used in clinical investigation or performance evaluation, the label must include specific information like product name, batch/lot number, date of manufacture, expiry date, storage conditions, and manufacturer’s details.
Labelling Requirements as Per the Legal Metrology Act, 2009
The following are some important lebaling requirements as per Legal Metrology Act, 2009:
Principal Display Panel
All essential labelling details should appear on the principal display panel of the device packaging. This ensures users can quickly access necessary information.
Mandatory Information
Labels must include the manufacturer, packer, or importer's name and address, product's common or generic name, net quantity, manufacturing date, packaging date, and retail price.
Font Size and Placement
The size of the letters and numerals used in labelling should meet visibility standards to ensure readability. The font should be clear and legible.
Consumer Contact Details
All packages must include contact details such as the manufacturer’s address, telephone number, and email for consumer complaints or queries.
Prohibition on Stickers
The use of stickers to modify labelling content is strictly prohibited, except in cases where the MRP is being reduced. Such stickers must not cover any mandatory declarations.
Handling Multi-Component Packages
If the product contains multiple items sold together, either the outer package should contain complete labelling information, or the inner packages should carry it with a note on the main package.
Old Packaging Material
Manufacturers are allowed to use outdated packaging materials if corrections as per the latest labelling rules are made. However, this is only allowed until a specified deadline.
Penalties for Non-Compliance
Violations of labelling regulations may attract a penalty of INR 2,000 under the Legal Metrology rules. This emphasizes the importance of accurate and honest labelling practices.
Conclusion
Medical Device Labelling Requirements in India are detailed and complex, aimed at safeguarding public health, ensuring product traceability, and enabling informed usage. By complying with the Medical Devices Rules, 2017, and Legal Metrology Act, 2009, manufacturers and importers can avoid penalties and ensure market acceptance. Partnering with regulatory experts such as Compliance Calendar LLP can help companies meet all the labelling requirements with confidence.
For assistance with your medical device labelling compliance, contact info@ccoffice.in or call +91 9988424211.
FAQs 
Q1. What are the key regulations governing medical device labeling in India?
Ans. The labeling of medical devices in India is primarily regulated by two frameworks: the Medical Devices Rules, 2017, and the Legal Metrology (Packaged Commodities) Rules, 2011. The Medical Devices Rules ensure that all medical devices meet safety, efficacy, and quality standards, while the Legal Metrology Rules mandate accurate and transparent declarations related to packaging, quantity, and pricing for consumer protection.
Q2. What basic information must be included on a medical device label in India?
 Ans. Every medical device label must include the product name, manufacturer’s name and address, batch or lot number, date of manufacture and expiry (or shelf life), net quantity, storage conditions, usage instructions, and safety warnings. Imported devices must also include the importer's name and address along with the import license number.
Q3. Is it mandatory to include a Unique Device Identifier (UDI) on the label?
 Ans. Yes. As per the Medical Devices Rules, all registered medical devices in India must carry a Unique Device Identifier (UDI) from January 1, 2022. The UDI includes both a device identifier (specific to the model) and a production identifier (e.g., batch or serial number) for traceability.
Q4. Can manufacturers use stickers to update MRP or other information on labels?
 Ans. Stickers cannot be used to alter mandatory labeling information except for reducing the Maximum Retail Price (MRP). Even in that case, the revised sticker must not cover or obscure the originally printed MRP or other essential label content.
Q5. Are there special labeling provisions for small-sized or reusable medical devices?
 Ans. Yes. For small-sized devices where full label information cannot be printed, essential details like product name, batch/lot number, and expiry must still be present. The outer package must contain full labeling details. For reusable devices, detailed instructions for cleaning, disinfection, and sterilization must be included on the label.
Q6. What are the labeling requirements for devices meant for export?
 Ans. Medical devices intended for export must meet the labeling regulations of the importing country. However, the label must still mention essential details such as the name of the device, batch or serial number, expiry date, manufacturer’s details, and the Indian license number.
Q7. What is the penalty for non-compliance with labeling rules in India?
 Ans. If a manufacturer or importer fails to comply with the labeling provisions under the Legal Metrology Act or Medical Devices Rules, a general penalty of ?2,000 may be imposed. Repeated violations can lead to stricter action by regulatory authorities, including product recall or cancellation of licenses.
Q8. How are clinical investigation or performance evaluation devices labeled?
 Ans. Devices meant for clinical trials or performance evaluation must be labeled distinctly. The label should include the device name, batch/lot number, manufacturing date, use-by date, storage conditions, and a clear statement that it is for clinical investigation or research use only.

Introduction to Medical Device Labelling Requirements in India Medical device labelling is an important aspect of ensuring both regulatory compliance and user safety. In India, the labelling of medical devices is governed primarily by the Central Drugs Standard Control Organization (CDSCO), under the Medical Devices Rules, 2017, and the Legal Metrology (Packaged Commodities) Rules, 2011. These rules are intended to provide consumers and healthcare professionals with accurate, comprehensive, and accessible information about the medical device. Manufacturers and importers must align their labelling practices not only to meet local legal requirements but also to support global harmonization efforts guided by international groups like the Global Harmonization Task Force (GHTF).

Regulatory Frameworks Governing Medical Device Labelling in India

There are two main sets of regulations that medical device companies must comply with for labelling their products in India:

Legal Metrology Act, 2009

The Legal Metrology Act, 2009, ensures standardization in weights and measures and governs the labelling requirements for packaged commodities. Medical devices, when sold as packaged commodities, must carry essential declarations such as the manufacturer’s details, product quantity, pricing, and other consumer-relevant information. This ensures transparency, consumer protection, and fair trade practices.

Medical Devices Rules, 2017

Formulated under the Drugs and Cosmetics Act, 1940, these rules are dedicated specifically to medical devices. The Medical Devices Rules, 2017, detail requirements regarding classification, registration, quality management, and especially labelling. These rules aim to ensure that medical devices available in the Indian market meet necessary safety and performance standards.

Contents of Medical Device Labelling

The labelling of medical devices in India must include detailed and standardized information that helps in identifying, handling, storing, and using the device appropriately. These labelling contents are grouped into three major categories:

General

1. Requirements Identification and Manufacturer Information

Each label must clearly state the name or trade name of the device along with the name and address of the manufacturer. For imported devices, the name and address of the authorized representative or importer in India must also be included. This ensures traceability and helps regulators or users to quickly reach the manufacturer in case of queries or complaints.

2. Device Details

Labels must provide enough information for users to understand what the device is and what it contains. This includes the common name of the device and a description that can help distinguish it from other similar products.

3. Tracking Information

Medical devices must carry batch numbers, lot numbers, or serial numbers. This information is vital for traceability and is used when recalls or quality control actions are necessary. It ensures that any faulty or compromised device can be quickly identified and addressed.

4. Usage Timeline and Manufacturing Date

Labels must clearly state the expiration date or the period until which the device can be used safely. This date should be expressed as a combination of the month and year. In addition, the manufacturing date must be included, either explicitly or embedded within the batch number or serial code.

5. Storage and Handling Instructions

Proper storage and handling are important to maintain a device’s efficacy and safety. Labels must specify any conditions that need to be maintained, such as temperature range, humidity, or protection from light. This information helps users store the product correctly until use.

6. Safety Information

Each label must include safety-related details such as warnings, potential side effects, and precautions. These elements are vital to inform the user about any risk factors or necessary protective measures while using the device.

7. Operational Assurance

To ensure correct installation and operation, labels must include essential maintenance instructions. This may involve component replacement or calibration needs to ensure that the device performs as intended throughout its lifecycle.

8. Preparation Requirements

For certain devices, specific pre-use preparations may be required. For example, if the device needs sterilization or calibration before use, this information must be clearly stated on the label.

Where is it applicable?

1. Sterilization Instructions

If the device is supplied sterile, it must include handling instructions, especially what to do if the sterile packaging is damaged. Methods for re-sterilization should be included, if applicable.

2. Usage Restrictions

If a device is for single use only, it must be prominently mentioned on the label. Similarly, custom-made devices, devices for clinical investigations, or those intended only for demonstrations must carry appropriate labelling statements.

3. Compatibility and Interference

Labels must indicate compatibility with other devices and highlight any potential interference risks. For example, electromagnetic interference risks should be noted if the device is used near MRI machines or other electronic devices.

4. Reusability

Reusable devices should come with detailed cleaning, disinfection, and sterilization procedures. The label must also mention how many times the device can be reused safely.

5. Radiation Emission

If the device emits any kind of radiation, the nature, type, intensity, and distribution of the radiation must be clearly described on the label. This helps users take necessary precautions.

Instructions

1. Device Performance

Monitoring Instructions must explain how to monitor changes in device performance. If any sign indicates that the device is malfunctioning, users should know what action to take.

2. Environmental Exposure

Labels should include precautions against magnetic fields, electrical interferences, and other environmental conditions that may affect the device’s functionality.

3. Medicinal Interactions

If the device administers any medicinal substance, the label must include information about the medicine, its quantity, and any usage restrictions.

4. Disposal Risks

Proper disposal is essential to avoid harm to health or the environment. Labels must include guidelines on how to safely dispose of the device after use.

5. Incorporated Substances

If the device includes any medicinal substances or other materials, they must be listed along with any usage limitations.

6. Accuracy and Usage Requirements

Devices with measuring functions must specify their accuracy limits. Moreover, labels should mention if any special training, qualifications, or facilities are required for correct usage.

Additional CDSCO Guidelines from Medical Devices Rules, 2017

The following are some additional CDSCO guidelines from Medical Devices Rules, 2017:

Indelible Ink

Requirement All labelling information must be printed using indelible ink to prevent tampering and ensure durability throughout the device's shelf life.

Shelf Life and Expiry

Medical devices must display both the date of manufacture and the date of expiry. For devices that are sterile, the date of sterilization may serve as the manufacturing date. In certain cases like stainless steel or titanium non-sterile devices, expiry dates may not be required.

Batch/Lot Numbers

Each device must carry a unique batch or lot number to maintain accountability and support any future corrective actions.

Storage Conditions

Any special requirements for storage, such as refrigeration or light-sensitive handling, must be noted on the label to ensure product stability.

Sterile State and Sterilization Method

If the device is sterile, the label must indicate its sterile state and specify the method of sterilization, whether it be EO gas, gamma radiation, or steam.

Warnings and Precautions

All necessary warnings and precautions, especially those pertaining to safe usage, must be highlighted clearly on the label.

Single-Use Indication

Devices that are meant for single use must be labeled with statements like "Single Use Only" or "Do Not Reuse."

Labelling of Physician Samples

Medical devices provided as free samples must be labeled as "Physician’s Sample—Not to be sold."

License Information

For domestic devices, the manufacturing license number must be mentioned. For imported devices, the import license number, name and address of the importer, and the overseas manufacturing facility must be included.

Use of Symbols

Internationally accepted symbols can replace text if they are universally understood by the intended users. This allows for multilingual accessibility.

Labelling for Small Devices

In cases where the device is too small to carry all the required information, only essential information such as product name and batch number should be included on the device, with full details on the outer package.

Export Labelling

Devices intended for export must comply with the labelling requirements of the importing country. However, Indian regulations still require labelling of critical elements such as device name, manufacturer details, lot/batch/serial number, expiry date, and license number.

UDI (Unique Device Identification)

Compliance As of January 1, 2022, all registered medical devices in India must carry a Unique Device Identifier (UDI). This includes a Device Identifier (DI) specific to the product and a Production Identifier (PI) that provides traceability.

Shelf Life Restrictions

In general, medical devices should not have a shelf life exceeding 60 months unless justified with evidence. Shorter shelf-life devices may have additional import requirements.

Labelling for Clinical Evaluation Devices

For devices used in clinical investigation or performance evaluation, the label must include specific information like product name, batch/lot number, date of manufacture, expiry date, storage conditions, and manufacturer’s details.

Labelling Requirements as Per the Legal Metrology Act, 2009

The following are some important lebaling requirements as per Legal Metrology Act, 2009:

Principal Display Panel

All essential labelling details should appear on the principal display panel of the device packaging. This ensures users can quickly access necessary information.

Mandatory Information

Labels must include the manufacturer, packer, or importer's name and address, product's common or generic name, net quantity, manufacturing date, packaging date, and retail price.

Font Size and Placement

The size of the letters and numerals used in labelling should meet visibility standards to ensure readability. The font should be clear and legible.

Consumer Contact Details

All packages must include contact details such as the manufacturer’s address, telephone number, and email for consumer complaints or queries.

Prohibition on Stickers

The use of stickers to modify labelling content is strictly prohibited, except in cases where the MRP is being reduced. Such stickers must not cover any mandatory declarations.

Handling Multi-Component Packages

If the product contains multiple items sold together, either the outer package should contain complete labelling information, or the inner packages should carry it with a note on the main package.

Old Packaging Material

Manufacturers are allowed to use outdated packaging materials if corrections as per the latest labelling rules are made. However, this is only allowed until a specified deadline.

Penalties for Non-Compliance

Violations of labelling regulations may attract a penalty of INR 2,000 under the Legal Metrology rules. This emphasizes the importance of accurate and honest labelling practices.

Conclusion

Medical Device Labelling Requirements in India are detailed and complex, aimed at safeguarding public health, ensuring product traceability, and enabling informed usage. By complying with the Medical Devices Rules, 2017, and Legal Metrology Act, 2009, manufacturers and importers can avoid penalties and ensure market acceptance. Partnering with regulatory experts such as Compliance Calendar LLP can help companies meet all the labelling requirements with confidence.

For assistance with your medical device labelling compliance, contact info@ccoffice.in or call +91 9988424211.

FAQs

Q1. What are the key regulations governing medical device labeling in India?

Ans. The labeling of medical devices in India is primarily regulated by two frameworks: the Medical Devices Rules, 2017, and the Legal Metrology (Packaged Commodities) Rules, 2011. The Medical Devices Rules ensure that all medical devices meet safety, efficacy, and quality standards, while the Legal Metrology Rules mandate accurate and transparent declarations related to packaging, quantity, and pricing for consumer protection.

Q2. What basic information must be included on a medical device label in India?

Ans. Every medical device label must include the product name, manufacturer’s name and address, batch or lot number, date of manufacture and expiry (or shelf life), net quantity, storage conditions, usage instructions, and safety warnings. Imported devices must also include the importer's name and address along with the import license number.

Q3. Is it mandatory to include a Unique Device Identifier (UDI) on the label?

Ans. Yes. As per the Medical Devices Rules, all registered medical devices in India must carry a Unique Device Identifier (UDI) from January 1, 2022. The UDI includes both a device identifier (specific to the model) and a production identifier (e.g., batch or serial number) for traceability.

Q4. Can manufacturers use stickers to update MRP or other information on labels?

Ans. Stickers cannot be used to alter mandatory labeling information except for reducing the Maximum Retail Price (MRP). Even in that case, the revised sticker must not cover or obscure the originally printed MRP or other essential label content.

Q5. Are there special labeling provisions for small-sized or reusable medical devices?

Ans. Yes. For small-sized devices where full label information cannot be printed, essential details like product name, batch/lot number, and expiry must still be present. The outer package must contain full labeling details. For reusable devices, detailed instructions for cleaning, disinfection, and sterilization must be included on the label.

Q6. What are the labeling requirements for devices meant for export?

Ans. Medical devices intended for export must meet the labeling regulations of the importing country. However, the label must still mention essential details such as the name of the device, batch or serial number, expiry date, manufacturer’s details, and the Indian license number.

Q7. What is the penalty for non-compliance with labeling rules in India?

Ans. If a manufacturer or importer fails to comply with the labeling provisions under the Legal Metrology Act or Medical Devices Rules, a general penalty of ?2,000 may be imposed. Repeated violations can lead to stricter action by regulatory authorities, including product recall or cancellation of licenses.

Q8. How are clinical investigation or performance evaluation devices labeled?

Ans. Devices meant for clinical trials or performance evaluation must be labeled distinctly. The label should include the device name, batch/lot number, manufacturing date, use-by date, storage conditions, and a clear statement that it is for clinical investigation or research use only.