Medical Device Labelling Compliance – Regulatory Requirements to Follow

Importers and Manufacturers of medical devices must satisfy many requirements regarding the data supplied with their devices. Medical device Label compliance in India ensures that health professionals and patients can find the needed information by looking at the label.

They need not look elsewhere to determine the quality and safety of the device. If you don’t follow the labeling guidelines set out by the Medical Devices Rules, 2017, you cannot sell them.

For instance, every device should have the information required to identify the device. The end user should also be able to identify the manufacturer and any important safety and performance information. This blog focuses on medical device labeling compliance and requirements, so you know what needs to be done before placing your devices in the Indian market.

 

What Is A Medical Device Label?

Medical device labeling or labelling is the information that a manufacturer provides that is linked to or affixed to a medical device container or device. It can also be information that is part of the wrapper for accurate, safe, and efficient use of a device by the end user.

So, a medical device label can be marketing materials like leaflets and brochures, product packaging, medical product descriptions, user manuals, or safety instructions. It can also be software that accompanies another system or a document that shows the operation of a medical device.

 

What Is Medical Device Label Compliance?

A medical device is an instrument, apparatus, or machine that is intended to diagnose diseases and prevent or cure them. Labelling medical devices implies attaching data or information to the devices. Medical device label compliance means that a manufacturer’s product fulfils all the quality standards according to the guidelines and rules laid out by the Central Drugs Standard Control Organisation (CDSCO) or the concerned Medical Device Regulatory Agency of any Country worldwide.

The necessary information should be printed in ‘indelible ink.’ The major details comprise symbols, instructions, warnings, and control data. Besides, manufacturers should adhere to specific rules related to label size, placement of the label, and product information.

 

Requirements for Medical Devices Labelling in India

The requirements for labelling medical devices can be categorized into three major categories. These include general requirements, special requirements that are applicable in certain cases, and special instructions that manufacturers need to follow. We have described these requirements in detail below.

General Medical Device Label Compliance Requirements

1. The labels should have clear information about the manufacturer along with their address. The importer’s name address, and medical device import license number are essential to be mentioned on imported devices.
2. Information about the contents of the device should be there. Users should be able to identify the specific medical device easily.
3. Batch codes, lot, and serial numbers should be there on the label to trace the device.
4. The shelf life of the safe usage of the device should be a part of the label.
5. If the device has a date of manufacturing, it should be a part of the label.
6. Storage or handling requirements should be mentioned on the external device packaging.
7. Safety information on the label is another important requirement. It includes any crucial warnings, precautions, and side effects.
8. The label should have information about the correct installation and functioning of the device. Mention the need for maintenance, replacing a part of it, or the need for calibration.

 

Special Medical Device Labelling Requirements for Special Cases

Special labelling requirements majorly comprise the need for sterilization, usage restrictions, and compatibility. It also includes the reusability of the device and whether it emits radiation.

1. The label should have information or instructions about handling the sterile package of the device. Besides, mention the process of re-sterilization.
2. Mention for whom the device is intended for. It can be for specific people (custom-made) or for one-time use only. The device can also be used for specific presentations or examinations. This should also be mentioned in the packaging.
3. Mention instructions about installing the device and potential conflict with other devices.
4. If the device is intended for multiple uses, mention the process to re-sterilize, clean or disinfect it.
5. If the device gives radiation, it is crucial to mention the type and intensity of that radiation.

Special Instructions to Follow While Labelling Medical Devices

Special instructions outline precautions, interactions with other products, and risks (if any). The device’s label should have the following information:

1. If the device’s performance changes after a certain period, mention the precautions that the user should take.
2. Mention the precautions that should be taken if the device is exposed to environmental elements, magnetic fields, electrostatic discharge, or any other similar thing.
3. Include information about medicinal interactions. This involves substance limitations.
4. The label should have complete details related to the disposal of the device if it poses any risks.
5. If the device has any medicinal substances in it, those substances should be a part of the label.
6. The device’s preciseness for measuring anything should be mentioned. This should be followed by the qualifications necessary for the user to use the device for measuring something.

 

Some Additional Points to Note

Medical devices are diverse in nature. It’s why there are also many instructions for labelling it. Given below are some special instructions that may be applicable to you as a manufacturer.

1. Every label should be in permanent or indelible ink.
2. If your device is made from a material that does not have an expiry date, like stainless steel, you don’t need to mention it.
3. The labelling ‘Physician’s Sample – Not to be Sold’ is a must if your device is to be distributed as a free sample.
4. Always use the metric system to show the overall quantity, such as weight, measure, volume, units, and devices in the package.
5. The manufacturing license number for devices produced in India should be mentioned after the words ‘Manufacturing Licence Number,’ ‘Mfg. Lic. No.’ or ‘M. L.’
6. If the devices are imported into India, mention ‘Import License number, ‘Imp. Lic. No.’ or ‘I. L’ for devices Imported into India.
7. If the device is compact and cannot legibly have all the information, include all the essential data on the label.
8. Approved medical devices should have Unique Device Identifiers or UDIs for their traceability. This is under a voluntary phase for now in India.
9. If the label cannot bear important information but is authentic and meets quality standards, it should have symbols by the Bureau of Indian Standards (BIS) or the International Organisation for Standardisation (ISO).
10. Importers can stick the label on the imported medical device or the retail pack. It counts as labeling.

 

How Can Dueran Consultant Help You?

According to CDSCO, every importer or manufacturer of the medical device must follow all the labeling conditions specified above. If the requirements are not met according to the stipulated guidelines, your license will be canceled. Dueran Consultant is a trusted regulatory solutions provider. We help manufacturers and importers satisfy the guidelines by CDSCO so you get a license for your medical devices without any difficulties.

Our experts are fully aware of the results of non-compliance. So, we diligently work with you to navigate the regulations. Our experts have helped thousands of importers/manufacturers get their licenses approved. Now, it’s your turn. Contact us today.