What is the state register of medical devices?

The database of all drugs and medical devices authorized for use in the Republic of Kazakhstan is called the State Register. It is replenished and updated as orders for new names are issued, and is monitored by an authorized body of the Ministry of Health. 

What is its purpose?

State Register of Medical Devices has several important purposes:

1- Ensuring patient safety. The registry helps ensure that only tested and authorized products are used in healthcare facilities

2. Keep records of medical products admitted to the market

Where is the registry located?

It is publicly available and anyone can find it on the website of the expert body ndda.kz in the online services section.
One frequent question is how to find and check the registration certificate for a medical device. It's very simple, go to the website www.ndda.kz - then "online services" - "medical devices" - "state register of medical devices". After clicking on the link you will be presented with fields for entering keywords. You can search by trade name, by RU number or by manufacturer's name and country. There is also an opportunity to set different filters: by dates of RI issuance, expired, active or all issued RIs for the whole time. The fields related to medicines are not filled in

How to use it properly?

After displaying the results, fail by clicking on the trade name you are looking for. A card of 8 tabs will open in front of you. Each tab contains relevant information. 

Let's dwell on each tab in more detail:

1. "Basic data" is the most informative section of the medical equipment register and articles, which contains information on the dates of receipt and expiry of the RI, expiration dates, trade name, purpose and field of application, and description of technical characteristics. Also, there is an indication of the risk class and nomenclature code. This section is often used by users or distributors when making purchasing decisions.

It is for this reason that this information is extremely important, and it is laid down when the dossier is collected, which is why we at the company lcs-kz we pay a lot of attention to that.

2. The "Orders" section will show the entire history of the types of procedures and orders passed. The information is important to understand in which year the first medical device registrationThe following are the dates on which adjustments were made to the dossier.

3. Manufacturer" tab - name and country of the main plant, its production site and authorized representative in Kazakhstan.

4. "Completeness" provides information on registered models, sizes, accessories and consumables. The information is very important for distributors, as it is related to such procedures as quality assessment and price limit examination. When receiving a quality certificate, the delivery notes are checked against the completeness, and discrepancies may be the reason for a reasoned refusal to issue an opinion.

5. "Performance Options". At first glance, the section is very similar to the previous one, but this section has its own role, and it is no less important. The point is that it is the variants of performance that are used to issue the conclusion on marginal prices. The prices of individual execution variants are recorded in the opinion. For this purpose, the information is entered in the approved forms of tables in the dossier and further gets into the state register of medical equipment and devices. In case of improper execution of tables, employees of the authorized body may recommend changes in the dossier, which may take additional 2-3 months. 

6. In the section "Instructions" approved instructions are available in Russian and Kazakh languages. The instructions necessarily include sections with a general description, purpose, rules of use and contraindications. Also, information about the manufacturer, its representative in the country and deciphering the symbols that are printed on the original packaging. The instructions for medical equipment are slightly different. It is bulkier in terms of the number of pages and often has a lot of graphic and schematic images, as a result, documents can take up a lot of space on servers and other storage media. In order not to burden the system as a whole, instructions for medical devices are not included in the state register of medical devices. However, they are always available in the dossier archive.

7. "Certificates". All quality certificates received (dates and numbers) for imported or domestically produced lots and series are recorded in this section.

8. "Packaging. This is one of the important sections, as all approved packaging and label layouts are located here. And any medical product, which is on the market of the Republic of Kazakhstan, must comply with the approved layouts. The regulator conducts annual sampling of goods from the market, according to an agreed schedule, and if such a violation is detected, it can regard it as a counterfeit product, which is subject to withdrawal from the market. When laying down post-registration risks, it is very important to explain to the manufacturer or his representative about the importance of providing up-to-date layouts, exactly those that will be put on the market after receiving the RI.

The register of registration certificates for medical devices is necessary for both consumers and state organizations. The register provides information about the registered trade name. Consumers can check which manufacturers have certain products included in the unified register of medical devices, their status and available models. The National Center of Expertise in turn uses it during amendments, quality assessment procedures and re-registration. These databases are often used to form technical specifications for tenders and competitions of medical organizations and SK Pharmacy.

Is there access to RI through the med product registry?

Since in order to obtain an RI, interested companies incur certain costs, both time and financial. And accordingly, many are interested in the issue of security and confidentiality of the issued RI. We often hear about the fact that in the Russian Federation, for example, the database of registration certificates for medical equipment and products has such a function as downloading a copy of the RU with watermarks. Since for importation of medical devices it is enough to provide a copy of the original RI, it seems that the confidentiality of the document is in question. However, firstly, it should be noted that customs services know how to distinguish between a copy of the original and a copy downloaded from a website, and secondly, the register of registered medical devices in Kazakhstan does not have such a function, there is access only to the information described above. Accordingly, there is no risk of third parties obtaining a copy of the RI through a publicly accessible website. RIs can be downloaded only through the personal cabinet of the e-license portal using an electronic key.