The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the labeling rules for medical devices introduced by the Order of the Ministry of Healthcare of the Republic of Kazakhstan earlier in January 2021. The document prescribes the rules to be applied with regard to the labeling of medicines and medical devices allowed to be marketed in the Republic of Kazakhstan. The present order also replaces the previous medical device labeling rules dated April 16, 2015.
The present medical device labeling rules are based on the Code of the Republic of Kazakhstan “On public health and healthcare system” and determine the labeling requirements.
The document provides the definitions of the most important terms used in this regard.
- According to the rules, the packaging of medicine (medical device) constitutes a measure or a set of measures ensuring the turnover process by the virtue of protection against damages and losses and also protecting the environment from pollution. The packaging comprises the inner (internal), intermediate (if applicable), and secondary (outer or consumer) packaging.
- Batch number – a distinguishing combination of numbers, letters, and (or) symbols, allowing to identify the batch of products, the full consequence of manufacturing and control operations, and also to track further marketing of medical products.
- Sticker – a piece of bearer information containing the marking with the information for the customer in Russian and Kazakh languages added to the secondary packaging.
According to the rules, the samples of labeling and stickers should be registered with the state authority in the course of the initial registration of a medical product. The information about the establishment receiving the claims and proposals with regard to the quality of medicines marketed in the territory of the Republic of Kazakhstan should be indicated in the instructions for use.
Medical Device Labeling Rules
Besides the aforementioned terms, the new rules also provide the definitions of the terms to be used in the case of medical devices. According to the document, one of the most important concepts is an operational document of a medical device – a document to be developed by the medical device manufacturer for its consumers, containing the information about construction, the principal mode of actions, parameters, characteristics (features) of a medical device, its components; indications necessary to ensure the correct and safe use of medical devices (including the use for the intended purpose, as well as technical maintenance, storing and transporting); recycling information, details of the manufacturer, supplier, and their obligations. The new rules emphasize that the operational document of a medical device and also the instructions for use should contain complete and accurate information that would be not misleading in terms of composition, features, the manufacturing method, and other aspects that directly or indirectly characterizing the quality and safety of medical devices.
As in the case of medicines, the information on the establishment receiving the claims and proposals with regard to the quality of medical devices should be indicated in the instructions for use and operational document of a medical device.
The labeling should be placed directly on each item of a medical device, the packaging, label, and should be provided in a short form. However, it should be sufficient to communicate to the consumer the whole scope of necessary and accurate information. The information should be provided in the form of text, separate graphical or color signs and/or pictures, or their combination. In this regard, the following rules should be applied:
- The signs should be recognizable and distinguishable from other signs;
- The same signs placed on a medical device should have the same meaning irrespectively of their functions, purpose, and also the way they are placed;
- Symbols and indications, used in labeling, should be defined in the instructions for use for a medical device an operational document of a medical device.
The labeling should be the same for each batch of medical devices and should be in Kazakh and Russian languages.
In the course of the assessment, an expert organization shall verify the authenticity of translation of all the labeling, stickers, and instructions for use, as well their compliance with the requirements set forth by the present rules.
The labeling should remain readable within the whole intended term of use of a medical device, so the methods and approach to be applied for placing the information should ensure the necessary quality of images. The requirements with regard to the safety during storing, transporting, distribution, use, recycling of a medical device should be provided in a distinguishing way (e.g. via the use of another color or font).
In case if the packaging containing medical devices is being placed into the additional packaging, such an external packaging should not prevent the reading of the inner label, or the same label should be placed on the outer packaging. At the same time, should it be impossible to place all sufficient information due to the size of the labeling, the appropriate labeling should be placed on the general (group) packaging.
The labeling contacting the medical device itself should ensure the durability of the information during storing, transporting, distribution, and use, as well as under the impact caused by the climate-related factors. At the same time, they should not impact the safety and quality of the medical device.
The intactness of the labeling used in the conditions of the active impact of the environment or other special conditions (high or low temperature, aggressive environment, or other similar conditions) should be ensured by the application of some or several means listed herein below:
- The use of the durable basic material.
- The use of the appropriate method on placing.
- The use of durable shelling.
The new rules prescribe the regulatory requirements for the labeling of medical devices. According to the rules, the labeling for manufacturers placed directly on a medical device, its packaging, sticker, should contain the following information:
- The name of a medical device (in case of a small label, the name could be provided in Latin letters, or in the language of the manufacturer);
- The name of the country of origin;
- The name and(or) the trademark of the manufacturer;
- The name and location (legal address) of the manufacturer and/or the license holder, in case of a generic medical device,
- Main features and characteristics indicated in the metrical system (the International unit systems): weight, main measures, volume, and power,
- The details, necessary for the customer to identify the medical device (e.g. machine-readable code),
- The expiry date (month, year) till which the medical device could be safely used,
- The year of manufacturing of an active medical device (as per the state standards of the Republic of Kazakhstan), together with the batch or serial number,
- Specific storing and/or use (operation) conditions,
- Indication of sterility (if applicable),
- Batch number,
- Indication of a single-use medical device,
- Indication of a custom-made medical device,
- An indication that the medical device is intended for clinical trials only,
- Safety measures to be taken,
- Trademark (if applicable).
Summarizing the information provided here above, the new labeling rules set forth the regulatory requirements the labeling of the medicines and medical devices should comply with. In particular, the new rules prescribe the way the information should be provided.
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