Replacement of the registration certificate for a medical device

When is replacement necessary?

In previous articles, we have repeatedly talked about the registration-related processes and how they affect the registry certificate. All of these procedures, conducted in the future with the RI or dossier, are inherent post-registration risks, the laying of which is important during the initial registration process. The more thoroughly the dossier is prepared, the more calmly the amendments, re-registration and quality assessment of the product is carried out. And being on the market is not limited to these manipulations, of course. If you look at these expected processes in the key of replacement of registration certificates, you can more clearly understand what the RU is in general. Let's look at each point in more detail, from practice lcs-kz.

Amending

How to replace the registration certificate for medical devices if you do not have registration?So, when it comes to VIRD, there are two options regarding RIs. This is the introduction, when there is a replacement of registration certificates for medical devices or without issuing an updated document. The introduction process itself ends with the issuance of an order to update the data in the registry. Regardless of whether you have a replacement of the registration certificate form or not. If the amendments concern only the data in the register and are not reflected in the document itself, you do not need to issue an updated form. For this purpose, when submitting on the licensing portal, you need to select the option "entering without issuance of RI". If, however, you have expanded the set, changed or adjusted the trade name or any change reflected in the certificate itself, the document itself must be replaced. In both cases, the issuance service will be free of charge and will take up to five working days.

Re-registration

As we recall, the validity of the registration certificate for some MIs is limited to a period of five years. These are almost all products, including machinery, that have been examined before February 2021. After the new rules came into effect, all MIs are issued indefinitely. To this day. This means that until about 2026, we will still have to go through the re-registration process for some products. And it also means that these registration certificates for medical devices are subject to renewal. Unlike VIRD, there's no option here to renew without issuance. And the cost of this service from the committee is 5 MRP. 

Why change the registration certificate for medical devices? Why is it so important to go through the re-registration procedure if your RI has an expiration date? It is necessary to ensure that your authorization document does not lose the status of national registration. The whole point is that regulation in the field of registration is moving from the national level to the all-union level, within the framework of the Eurasian Economic Union. According to the latest updates, from January 2026, the national registration in the countries of the union completely ceases, and new registration will be possible only under the rules of the EAEU. That is, from January 2026 in countries such as Kazakhstan, Russia, Belarus, Armenia and Kyrgyzstan, applications will be accepted only under the new rules. This procedure is more complicated and lengthy if compared to the national one. And if it is important for you to retain the national status, you should remember that this is possible when replacing the registration certificate for medical devices before its expiration date. That is, you need to go through the procedure of prolongation of this document. 

At the moment, re-registration is not a complicated process. It has been simplified to four necessary documents and by order, the terms of this service are thirty days. But, in practice, most often, the whole procedure takes 2-3 months. However, care should be taken to ensure that even before the start of re-registration, there is confidence that there have been no changes in the dossier. Neither in the names, nor in the number of components, nor in the layout and instructions. Since there is nothing more unpleasant than finding out in the process that a VIRD should have been made. Therefore, analyze the dossier before submission. You can do this by lcs-kz.

Another good point is that you do not have to wait until your authorization certificate expires. You can apply for re-registration any time you decide you need indefinite status. And we even recommend doing so right now. The fact is, the longer a product is on the market, the more likely it is that the manufacturer is already making changes. And probably forgets to warn you about it. There is even such a practice, when you know that you need to make a VIRD, but you decide to re-register with the old data to get an indefinite RI. And after that you can do the RI in peace. Yes, this is also possible. The main thing, then consistently do all the actualization and calmly stay on the market. You will need up-to-date information when registering price caps, participating in tenders, quality assessment, reaudits, withdrawal from the market and even in case of identified incidents.