Registration certificate for a medical device

For what?

Any process of legalization, whether it is national registration or under the rules of the EAEU, logically ends with the issuance of an authorization document. Such a document gives the right to import and distribute a medical product on the territory of the country or a number of countries. For Kazakhstan and EAEU countries such authorization is called a registration certificate, abbreviated RU. It is issued by the authorized body in the field of health care, after a positive conclusion of an expert organization. So what is a registration certificate for a medical device and how to obtain it? Let's start at the beginning.

Where to start?

If you thought in the previous paragraph that there are two service providers involved in this process, you did not. Indeed, when we ask who issues a registration certificate for medical devices, the direct answer is the Committee for Pharmaceutical and Medical Control. But the committee relies on an expert opinion, namely the National Center for Expertise of Medicinal Products and MI. Obtaining a registration certificate for medical devices begins with the examination process. A dossier is collected for the product and submitted through the portal to the expert body. This is how the registration process begins. And it will last from 4 to 8 months, depending on the risk class of the product, on the need to pass laboratory tests and on the quality of the dossier itself, of course. During the examination stages, the applicant will go through a full review of the collected documents, receive comments and questions from the competent persons, respond to all these requests and supplement the dossier as necessary. The importance of the examination process cannot be underestimated, because without its successful completion, the RI will not be issued to you. During this process, you need to consider all the potential risks awaiting the medical device on the market. After all, obtaining a reg. authorization is only the first step. It is much easier to handle on the market with a normally conducted registration. By the way, we can help you with this at lcs-kz. If, based on the results of the examination, you are denied further registration, you need to reconstruct your dossier taking into account the identified comments and reapply. And yes, go through the whole process again, step by step.

What's next? National rules

When the registration has been completed with a positive result, it is possible to apply for a registration certificate for medical devices. This takes place on a different portal, as this service is provided by a different body. In case of national registration, the submission takes place online, on the e-licensing website through the personal cabinet of the applicant's company. The fee for one registration certificate for medical devices for the Republic of Kazakhstan is 11 MRP for registration. After payment and successful submission, the review period is 5 working days. Sometimes, issuance may take place earlier. In any case, we recommend checking the office every 2-3 days. As the application status will change as it moves towards issuance, you should also keep an eye on it. Because there are cases of motivated refusal. This is most often due to errors in the technical plan. Incorrectly specified application number, incorrectly paid amount, etc. If you received a rejection, it's okay, you can reapply again. But again you will have to wait up to five working days. You will receive the RU in electronic form. The data on the product are included in the unified register of medicinal products and MI.

What's next? EAEU rules

When registration is carried out under Union rules, it is necessary to obtain a registration certificate for medical devices through a different procedure. Yes, here the issuance will not be online at all. The point is that when we register under the EAEU rules, the expert bodies of the countries discuss the results within the expert information system and exchange their decisions with the authorized body themselves. When the expertise on the part of the reference state is completed, its results are transmitted to the country of recognition. The expert body of the country of recognition conducts its examination and makes a decision - either it recognizes the results of the reference country or not. After receiving the answer, the reference country transmits the information to the authorized body, which in turn draws up the EAEU RI on paper. There, in addition to the referrer country, the country/countries of recognition are indicated. Therefore, the number of the registration document looks like a series of country designations and a number. For example, KZRUKGZ 008. Further, the data get into the unified register of the Union.

Staying in the market

The registration certificate for a medical device applies to the trade name and site specified in it. If you want to introduce new models or modifications, as well as sizes, colors and smells of the original product, you will have to go through the procedure of making changes. During this procedure, the validity of the RI is not suspended. But the import of new models will be possible under the valid certificate only after the new data is reflected in the registry. It is necessary to make changes to the registry certificate in time to ensure that the data on your MI are always up to date. There are currently 11 types of amendments, which is quite extensive. 

Under current regulations, a registration certificate for a medical device is issued indefinitely. This applies to national regulations and the EEU. Previously, it was issued for 5 years, after which re-registration and re-issuance of the registration certificate was required.