Labeling Requirements for Medical Devices in India

When you start manufacturing your medical devices, labeling plays a major role afterwards. But are you aware that you must understand the labeling requirements for medical devices in India?

Labeling is vital in ensuring the safe and effective use of medical devices. The labeling requirements are governed by the Medical Devices Rules, 2017, under the guidance of the Central Drugs Standard Control Organization (CDSCO). 

The CDSCO rules and regulations mandate the specific details need to be displayed on the medical device labels, ensuring transparency, safety, and compliance.

Proper labeling is not only essential for healthcare professionals it is also valuable for users about the device’s intended use, specifications, and precautions but also aligns with global standards, boosting consumer confidence and market access.

Understanding these requirements is essential for manufacturers, importers, and distributors operating in India’s regulated healthcare sector.

Understanding Medical Device Labeling Regulations in India

When you need to obtain labeling rights then you must understand them first. The product labeling of the medical devices is done as per the Medical Device Rules 2017. These laws are implemented to show the transparency of the production of medical devices and other items.

Proper labeling provides critical information about the device, including intended use, safety precautions, and performance specifications, ensuring user safety and regulatory compliance.

What Does Labeling Requirements for Medical Devices Means? 

In simple words, medical device labeling exactly means all the essential details listed on the medical device, such as its intended use, content, precautions, and risks. Medical device labels also contain information like safety instructions and other details. These details can be found on the packaging, instructions for use (IFU), or other types of promotional details.

Do’s & Don’ts For Labeling Requirements for Medical Devices

Here we have mentioned all the do’s and won’t’s of medical device labeling, that you must follow, and read thoroughly:-

Do’s of Medical Device Labeling

• Clear & Concise Details – Easily understandable words
• Add Safety Information – Always list the safety instructions and warning mentioned on the label
• Provide Usage Instructions – Mention how to use the medical device
• Include Manufacturing Information – Add the manufacturing details on the label 
• Follow Legal Standards – Adhere the rules and regulations set by the respected authorities 

Don’ts of Medical Device Labeling

• Don’t Fool Users – Should avoid all kinds of misleading information and vague details.
• Don’t Overcrowd the Label – Too much unnecessary information can be confusing for the users, so try to add only important information on the label.
• Don’t Forget Language Requirements – Local language should be used for better understanding by the users. 

Important Labeling Requirements as Per the Legal Metrology Act, 2009

S.No	Requirements	Description
1.	Company Details	Must Include Name, Address, and Contact details of the manufacturer
2.	Language Details	Labels should be in the English language so that everyone can understand it
3.	Information of Product	Informative description of the device, model number, and intended use.
4.	Expiry Date/Shelf Life	The expiry date should be mentioned on the label in clear words
5.	Warning & Precautions	Must add the warnings on the label

What are the Labeling Format & Placement Guidelines For Medical Devices?

When you manufacture a product then understanding the Labeling Format & Placement Guidelines is necessary. So the points you must consider are:

• The label should be legible, indelible, and placed on the outermost packaging.
• The font size of the packaging must be easily readable (specify the minimum if rules define it).
• For small packages, a leaflet with information can be used.
• If space is limited then you must consider the internationally recognized symbols.

What Is The Language Requirement For The Medical Device Labeling?

As per the CDSCO + Legal Metrology require label in ENGLISH, but, as per the new update the local language preference is rising. You can consider the following points:

• Labels must be in English.
• Additionally, regional language(s) may be used for better understanding by patients (especially for over-the-counter or home-use devices).
• IFUs (Instruction for Use) must also be in a user-comprehensible format.

Barcodes & UDI Compliance Labeling Requirements for Medical Devices

For the labeling of medical devices, you must understand the Barcodes & UDI (Unique Device Identification) Compliance is mandatory for certain classes and aligns with global best practices. The points you must consider:

• As per CDSCO guidance, UDI must be included for Class C & D devices.
• Must contain Device Identifier (DI) and Production Identifier (PI).
• Helps in recalls, adverse event reporting, and inventory management.

CDSCO-Specific Import Labeling Requirements for Medical Devices

Before sale in India, CDSCO mandates additional declarations for Importers. Imported medical devices must have:

• Importer name & address
• Manufacturing country
• Import license number
• MRP with all-inclusive taxes

Provisional labeling accepted with the undertaking at the time of import (to be replaced with the final label before sale).

Penalties for Non-Compliance Of Labeling Standards For Medical Devices

If you are making errors in the labeling of medical devices or any other product then you must understand the seriousness of labeling errors first as follows:

• Fines, product recalls, or cancellation of license.
• Action under the Legal Metrology Act, 2009 or D&C Act, 1940 for false/misleading labels.

Device-Specific Labeling Requirements (Explained)

Not all medical devices are alike – different classes and types of devices serve unique functions and pose different risks. Hence, labeling requirements vary depending on the device’s intended use, risk class, and mode of application. Here’s a breakdown of specific labeling needs by device type:

Sterile Medical Devices

These are devices that are sterilized before use, such as syringes, surgical gloves, or catheters. Label must include:

• Sterility Method – You must add the sterility method such as “Sterilized using Ethylene Oxide (EtO)” or “Gamma Irradiated. This indicates the users about the sterilization technique while using.
• Date Of Expiry After Opening – A few of the sterility devices lose sterility once opened, so it is important to indicate the timeframe for safe use after the first opening.

Symbols: Internationally recognized symbols like:

• ❌ “Do Not Reuse” — for single-use items
• 🔄 “Sterilized Using…” symbol — to specify sterilization method
• 🧴 “Keep Dry” — if moisture can compromise sterility

It is important to update because prevents contamination and ensures patient safety by guiding proper handling and disposal.

Implants Devices

Devices that are meant to be placed permanently in the human body such as hip implants, pacemakers, and dental implants. The labeling of the product must include:

• MRI Compatibility – You have to mention whether the device is safe for magnetic resonance imaging (MRI) environments.
• Material Composition – Titanium, ceramic, or other materials must be declared to avoid allergic reactions or surgical complications.
• Lot/Batch Number – For long-term traceability in case of recalls or adverse event investigations.

It ensures that surgeons and hospitals understand the compatibility of the imaging equipment and potential risks due to material sensitivities.

Electronic Medical Device

The Electronic Medical Devices are the devices such as ECG monitors, infusion pumps, defibrillators, etc. Label must include:

• Safety Class – Defines insulation type and risk of electric shock. E.g., “Class II, Type BF” indicating protection level and body-contact type.
• Voltage and Frequency Requirements – To inform users of operating limits (e.g., “Input: 230V, 50Hz”).
• EMC Compliance Statement – Confirms the device won’t interfere with or be affected by electromagnetic devices. Often includes the symbol or reference to IEC 60601 standards. 

It is required because helps to prevent electric hazards, device malfunction, or EMI issues in hospitals where multiple devices operate simultaneously.

Labeling Checklist for Manufacturers Of Medical Devices

Label Element	Mandatory?	Notes
Device Name	✔	Same as on IFU
Batch/Lot No.	✔	For traceability
Manufacturing & Expiry Date	✔	Format: MM/YYYY
CDSCO License Number	✔	For all licensed devices
UDI (if applicable)	✔	For Class C & D
Country of Origin	✔	Especially for imports
Storage Instructions	✔	If temperature sensitive

Additional Points For Labeling Requirements for Medical Devices As Per Medical Devices Rules, 2017

• Unique Device Identification – Most of the high-risk medical devices require unique device identification codes for better repellent and tracking.
• Regulatory Approval – The label should consist of regulatory approvals by the Central Drug Standard Control Organization (CDSCO)
• Storage Condition – If a medical device needs to be stored in the refrigerator, it should be written on the label.

Conclusion

Labeling plays very much of an important role in marketing the product. It is required to check that the medical devices are meeting the standards set by the high authorities. Manufacturers must follow strict guidelines and make the medical device safe and effective for the consumers. By following these rules manufacturers make it clear that devices can be used nationwide without any kind of harm to life. 

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