What you need to know about registration of medical devices

Any medical devices, including medical equipment, products for in-vitro diagnostics or as it is called worldwide "medical device", in order to enter the market for general use, must undergo a registration process. In the Republic of Kazakhstan it is possible to undergo state registration or under the rules of the EAEU.

Why do I need to register medical devices?

This is a prerequisite of the RK Health Code. To ensure that a medical device, medical equipment or software is guaranteed to be safe for the end user, i.e. for you and me in the long run. Agree, few people would avoid interacting with a polyclinic or a laboratory to take tests, right?
Registration is necessary for both domestic producers and foreign companies that want to enter our market or the common market of the EAEU.  

Which medical devices are subject to registration?

Medical devices subject to state registration are products for use in hospitals, homes, ambulances, and medical offices. So it is not only syringes, systems, bandages and gauze or pregnancy tests, it is also MRI machines, lights used in operating rooms, ECG machines, X-ray machines, software used in these machines and even entire dental offices. This is a partial list of what is subject to registration. And sometimes borderline products are also required to have a document of conformity as an MI. What are these borderline products? Well, for example, disinfectants used in operating rooms. Respirators with special protection class, hospital furniture, etc.

This, incidentally, is the peculiarity of the registration of medical devices. Some of them may or may not be subject to compulsory registration. More precisely, they may or may not belong to medical devices. That is, in this respect it is even a little easier with medicines, everything is subject to registration there, if it is actually proven that it cures. So in order to accurately determine whether your product should be registered, an expert body conducts a special expert examination of accessories. We accompany such applications too. There are some nuances there.

Procedure for registration of medical devices

Requirements for the registration of medical devices are determined by legislation, special orders in this area. There are several of them, but there are two main ones. The first is about the procedure for registering medical devices. It gives the basic regulations on the general process, which bodies are involved, who is responsible for what, at what stage, in terms of regulation. The second - it is now called CR-DSM 10 - is about the rules for the registration of medical products. These orders are common for medicines and medical devices in fact, and it is important not to get confused here, they are divided into blocks.

Registration of medical devices is carried out by two state bodies - the National Center for Drug and MI Expertise, where the examination of medical devices directly takes place, and the Pharmacy Committee, which issues a certificate of registration. And all these stages are accompanied by the manufacturer of medical devices, its authorized representative and proxy, such agencies as ours (lcs-kz). Ideally all together. We calmly, harmoniously collect the necessary documents for the registration of medical devices, which are compiled into a dossier, and then go through the stages of registration in NCELS. There are four such stages, sometimes one falls out, it all depends on the manufacturer of the products. During the examination, not only the completeness of the dossier is checked, but also the quality of the documents submitted for examination. Each report or letter must prove that the product being registered is effective, safe and properly tested. When we have four stages of examination, one of them is laboratory testing of finished products. This stage tests the technical and biological characteristics you claim for the product you are submitting for review.
And of course, at any stage of the examination, we may receive questions from the expert body. This is an absolutely normal phenomenon. This is why, by the way, the registration periods are so long. Legislatively, experts are given time to analyze the product qualitatively, and we are given time to answer questions. On average, the state registration period varies from five to eight months. Sometimes longer, depending on the difficulties arising in the process. When we register within the EAEU, the period can be as long as one and a half or two years, it's all about a slightly different procedure. But you have to bear in mind that within the union we register a medical device for five states, not one. Accordingly, more questions are inevitable here.

Registration certificate

In the end, having passed all the stages and steps, we receive a certificate of registration of the medical device. This document will be the final result of our work. In Kazakhstan and in the countries of the Eurasian Economic Union, it is called a registration certificate. It is issued for an indefinite period. Both in the case of state registration and in the EAEU. Previously, after five years it was necessary to re-register, now this requirement has been abolished.
This RU will then be amended when something changes in the dossier in the future. For example, the marking layouts will change, the authorized representative will change or the product itself will change. These are all subject to changes in the registration dossier. It is necessary to keep track of these moments and make the necessary changes in time, so that the registration certificate does not lose relevance and there are no problems on the market.