Registration of medical devices with LIMI Consulting Service

We have been in the medical device registration business since 2018 and we can tell you something interesting from experience. Medical device registration service in our company is not about getting you a registration certificate at any cost in three months. Registration of medical devices quickly is a myth! We can say with certainty that quality will suffer with this approach. No, your RI will not be different from all others by color or lack of QR codes. But your dossier will be incomplete, illogical and minimal. Collecting and analyzing the registration dossier is our strong point, because we do it with post-registration risks in mind.

Stages of registration of medical devices

Registration of medical devices in Kazakhstan is divided into two main periods. The first is the collection of documents prior to submission to an expert body, and the second is the passing of an expert examination in that body. What other body is there? The National Center for Expertise of Medicines and Medical Devices under the Ministry of Health of the Republic of Kazakhstan. The collected dossier is submitted there and during the whole period of expertise it will be studied by the best experts of the RK in this field. We are waiting for 4 stages. The first one is the assessment of completeness of the collected dossier. Have we given everything on the list, have we missed anything, have we complied with all formats and requirements. The second is to assess the quality of this documentation. Are all the reports from the product we need, do they contain everything we need, are all the procedures and letters correct, do all the addresses and models match, do the documents not contradict each other. The third stage is laboratory testing of the finished product. This stage doesn't always happen. Whether you have it we will find out at the initial diagnosis in our company. The fourth stage is the conclusion on safety. It is considered that this stage is technical and not expert, but according to experience, it is not so. Data coordination is the most responsible thing, if we do not want to correct mistakes by making changes. As a result, we receive a registration certificate and can safely be on the market.
A slightly different procedure is followed for registration within the Eurasian Economic Union. This registration is subject to slightly different rules and can theoretically be carried out for five states: Kazakhstan, Russia, Belarus, Kyrgyzstan and Armenia.

Our advantages

What do we do? We accompany both periods. We collect and analyze the dossier together with the manufacturer, then we submit it to the state authority and follow the examination process until we receive the RI.
What else do we do? As needed, we offer document development, no middlemen, no outsourcing, no overpayments. And also selection of laboratories for product testing, when developing.
And of course, we are always on call to advise on registration.
The full cost of registration of medical devices can be found out by passing the initial diagnosis in our company on four documents absolutely free of charge!