Labeling of medical devices

Labeling of medical devices is one of the important stages of production. This is how the consumer gets all the necessary information about the product and the manufacturer, and is guided by it when making a subsequent choice.

The rules of labeling of medical devices, namely its content and appearance are regulated by the internal rules of the manufacturer itself and state acts. In this case, it is the order of the CR DSM 11. 

Labeling of medical device packaging - is the necessary information, except for advertising, provided in a concise but sufficient form and including manufacturer's data, data on composition and physicochemical properties, methods of use, storage conditions. In other words, everything necessary for safe and proper use

What information should be included?

According to the order, the labeling of medical devices must contain the following the following information:

1.  Trade name. If the application area is less than 50 cm²If the label does not provide data in the Kazakh and Russian languages, the applicant shall approve the text of its design in a special form. If the label does not provide data in Kazakh and Russian languages, the applicant shall approve the text of its draft in a special form. Additionally, it is allowed to provide a separate sticker, which is applied over the original package.
2. Manufacturer's country.
3. Registered trademark of the manufacturer. Specified if relevant.
4. The address of the actual manufacturer or its legal manufacturer.
5. Basic Description. Specifies dimensions, volumes, quantities and other necessary properties for users.
6. Barcode (optional). This code is necessary for traceability and identification of goods and must be located in an easy-to-read place.
7. The period of storage or use after which use is not recommended.
8. The year of manufacture must be included as mandatory only for active devices.
9. Special storage conditions, temperature regimes, protection from moisture, light, etc.
10. The "sterile" symbol for sterile devices.
11. Batch or batch numbers shall be specified by the manufacturer in any format convenient to him.
12. For disposable products, a special warning is applied to avoid reuse or sterilization.
13. If the goods are custom-made, the relevant information must be labeled.
14. The "not for sale" mark is used for importation, for various research or for registration purposes.
15. Precautions. Detailed instructions for use, including precautions, contraindications and deciphering of all symbols and signs on the packaging are included in the instructions for use.
16. Trademark. If available.

Do medical devices also need to be labeled?

For technology, this also applies, however medical device labeling is slightly different, and it is called a label or "nameplate". This designation for machinery is provided in the original language and is not approved in the state register after registration.

What else is important to consider?

• All types of labels approved during examination are entered into the State Register, and the manufacturer is responsible for compliance with the approved data. Labeling of medical devices is one of the important quality indicators, non-compliance with which is equated with counterfeiting. In case of any correction of the label, the manufacturer is obliged to amend the dossier by submitting an application to the national center. Such amendments are one of the most frequent among our projects lcs-kz.
• If the product is double-packed and the outer package does not cover the information of the inner package, it is not necessary to duplicate the data on the outer package. And if the primary package is less than 50 cm²and it is unlabeled medical devices, then all necessary information is indicated on the secondary or group packaging.
• There are certain labeling requirements for medical devices regarding the quality and method of application. For example, holographic marks, braille, symbols and pictograms can be applied, and any application must be retained until the end of the shelf life of the product. And if some of the application materials are in direct contact with the device, the factory ensures that the quality is not affected by such contact.