Requirements of Labeling of Medical Devices in India w.r.t. MDR 2017 & Amendments

In India, for the manufacture, import, and sale of medical devices, one must adhere to the Medical Device Rules, 2017, of the Central Drugs Standard Control Organization (CDSCO). The rules ensure that medical devices meet safety and quality standards. Labeling is one of the important elements in following the standards as it provides critical information to healthcare professionals and patients.

The Legal Metrology Act, 2009, further requires that all pre-packaged goods, such as medical devices, comply with the prescribed labeling standards. It is essential to comply for both legal and transparency and accountability to consumers.

This blog delves into the most important labeling requirements for medical devices under the Medical Device Rules, 2017, and why manufacturers and importers in India must strictly adhere to them.

What is a Medical Device Label?

A medical device label is an exhaustive list of all the vital information regarding the device, which includes its name, intended use, safety measures, manufacturer details, risks involved, precautions taken, expiry date, and many more, with the aim to safeguard the end-users and patients.

Important Labeling Requirements of Medical Devices in India

Medical devices, under the Medical Device Rules, 2017, are required to have certain labeling on the label, including but not limited to:

• Device Name: Clear identification of the medical device.
• Usage Details: The details that ensure users fully understand how and for what purpose the device is used.
• Manufacturer's Details: The manufacturer's name and address, and the address of the manufacturing location.
• Net Quantity: The exact quantity in terms of weight, volume or number of units, depending on the case.
• Date of Manufacture/Expiry: The month and year date of manufacture and expiration or shelf life of the device.
• Sterilization Information: For items that are sterile, date sterilized and method.
• Biological/Medicinal Product: If the item contains a medicinal or biological product.
• Storage/Handling Instructions: Other specific storage and handling instructions.
• Warnings/Precautions: Any caution or information related to hazards.
• Batch or Lot Number: Traceability in form of batch or lot number.
• UDI: As required by Central Government
• Single-Use Devices: Mark single-use devices as such.
• Regulatory Numbers: Manufacturing license number (for domestic devices) or import license number and details for imported devices.

Additionally, labels may include recognized symbols from the Bureau of Indian Standards or ISO, to provide further clarity and standardization.

Why is Medical Device Labeling Crucial?

• Patient Safety: Proper labeling ensures safe usage, reducing the risks of misuse or adverse events.
• Regulatory Compliance: Failure to comply with labeling standards may result in penalties, recalls or market withdrawal.
• Traceability: The labels have batch and lot numbers and UDI to help track devices at the time of defects.
• Risk Management: Labels contain warnings and precautions to reduce potential risks.
• Storage & Handling: Proper guidelines for maintaining and storage keep the devices working.

How Regulatory Solutions India Can Help You?

Regulatory Solutions India is an affiliation that has been a reliable partner to a host of medical device manufacturers and importers since 2011. The leading role in the CDSCO labeling regulations can guide you all through preparing, submitting, and ensuring labels meet the right criteria to get to approval.

Partner with RSI to navigate the complex labeling requirements for the medical devices in India, ensuring compliance, safety, and success in the market.

Visit our blog on Legal Metrology Compliance for Medical Devices in India to know more about labeling and compliance.