Re-registration of medical devices

When to do

This procedure is gradually becoming a thing of the past, but still requires clarification. It is a process that requires updating the current data in the registry and re-registration of the MI certificate. For quite a long time in Kazakhstan the rule was that the registration certificate after the first receipt is valid for 5 years, after which it is necessary to re-register. Re-registration of medical equipment was required after 7 years. With the introduction of general rules on registration within the EAEU and their harmonization with the national procedure, the registration certificate is issued indefinitely. However, all medical devices and equipment registered prior to the updated legislation still require this procedure.

Previously, re-registration of medical devices required almost as much labor-intensive work as the initial registration. This was because the list of documents for the dossier was almost identical to the registration list. Now, re-registration of medical devices in Kazakhstan is carried out using only four documents.

What's the procedure

In general, the submission of documents is carried out in the same way as for registration. A dossier is collected, a contract and payment are created on the portal, and then the documents are uploaded. The re-registration of medical devices does not require the submission of samples or re-audit.

However, while seemingly simple, there are two most important rules. First, absolutely nothing must be changed. Neither the address, nor the name, much less the manufacturer. That is, the expert organization is ready to conduct the procedure on a simplified and accelerated version to confirm the relevance of the dossier, but only with the guarantee that nothing has changed there. Accelerated, because the whole term of re-registration, including all stages, is thirty days. Previously, the process could take as long as registration. And second, re-registration must begin before the expiration of the valid certificate.

Therefore, before starting the procedure, you should make sure that all data in the dossier and the RI are up to date. If something has changed, but you did not pay attention to it, make sure that it does not require any changes. Because very often, the re-registration is remembered when the RI expires in a month, and when you start the process, it turns out that a lot of things have changed and it is necessary to make a VIRD. But while you do it, there is a risk that the certificate will expire and you will not have time for re-registration. Which means you'll have to re-register. Don't take that risk, go for analyzing .

What is VIRD

VIRD is the amendment of the registration dossier for a medical device. In other words, making corrections or replacing outdated data with current data. At the moment there are 11 types of amendments. That is, 11 different possibilities to update the RI in the part where the data has been replaced. Sometimes, if you do not find the item you need, the actualization can be done through another type, you just need to find the right one. Making changes is carried out with a minimum package of documents. Most often these are just documents proving that the change you are making was actually initiated by the manufacturer and it does not affect the quality of the final product.

Some VIRDs involve the provision of samples and a phase of analytical expertise. These are cases where there have been adjustments in the manufacturing process or other process related to the quality of the product. For example, the shelf life of the product, the color, or the method of sterilization may have changed. All of these require a VI.

On average, this process takes from 2-4 months, depending on the type. The timeframe is also affected by the completeness of the documents submitted, the presence or absence of comments from the experts, and the speed of your response. Before the VIRD, it is necessary to thoroughly review the original file and the impact of the amendments. Because some seeming amendments are not amendments at all. For example, a change of address of the production site or a change of the legal manufacturer will be a reason for a new registration. Therefore, everything is not so clear-cut when it comes to VIRD. As is the case with re-registration.

Registration certificate

After the examination, you will need to renew your RI upon re-registration. You will now have an indefinite RI. But this does not mean that it is no longer necessary to keep it up to date. So, on the licensing portal we apply for the issuance of the RI, all the same as when registering. The term of issuance is up to five working days, but the fee is half as much, 5 MRP. By the way, the issuance of a reg. license when making changes is free of charge. The data will come in electronic format, and the information in the register will be updated within 1-2 days. Do not forget about timely changes!