Peculiarities of registration of imported medical devices in Kazakhstan

Is there a difference?
Kazakhstan, as one of the largest countries in Central Asia, strives to ensure the availability of modern and effective medical devices for its citizens and to maintain high standards in healthcare. This means that the rules for registration of medical devices in Kazakhstan are quite strict and require compliance with certain procedures (LCS-kz).

Which type of registration is easier - domestic or imported products? In fact, none of them. Both domestic and foreign manufacturers provide the same package of documents, which requires careful preparation on the part of the manufacturer. However, the registration of imported MI has its own peculiarities in the preparation of the dossier. Let's break down which ones.

Choice of representative

To successfully register an imported medical device in Kazakhstan, the manufacturing company must also take into account specific requirements and rules established by the country's legislation. This includes the need to have an acting representative of the manufacturer in Kazakhstan, who will control the quality and safety of the product after registration. This is the first thing a foreign manufacturer will have to take care of.

The selection of an Authorized Manufacturer's Representative (AMR) is a very important aspect and should be taken seriously. Since this legal entity will not only have access to the registration certificate, but will be able to dispose of it on an equal footing with the manufacturer. You can check the registration certificate for a medical device in the state register of medicinal products and medical devices, where the relevant section specifies who is the authorized representative of this RU.

Our blog already had an article on the topic of post-registration risks, where the choice of PPM was also considered to be a risk that should be thought about in advance (LCS Blog). When the product is already on the market, the last thing a manufacturer wants is to have problems due to unresolved paperwork or other issues with the representative. Therefore, it is recommended to conclude a contract detailing the obligations of the parties. After all, having access to the RI is not only a right, but also a responsibility.

Official certification

The next thing producers face is notarization according to international norms. Fortunately, this is not a requirement for all dossier documents. There are official types of documents such as license, free sale certificate, declaration of conformity and others, depending on the producer's country, which are provided in an approved form. 

And if the CIS countries can do with just notarization of copies, then with other foreign countries everything is a bit more complicated.

Registration of medical devices in Kazakhstan begins with the conclusion of an agreement with an expert organization. For this purpose, a foreign manufacturer issues a power of attorney to its authorized representative with the right to carry out manipulations with its product on the territory of the Republic of Kazakhstan. This power of attorney must be drawn up in accordance with the form of the current requirements of the regulatory body and certified according to the norms of the country where the manufacturer is located.

There are two main types of approval. These are apostille and legalization. Apostille is used by countries that are members of the Hague Convention. The rest go through the procedure of legalization through the embassy. In different countries, this process has its own peculiarities. Therefore, it is necessary to start certifying documents in advance, taking into account the rules of the country of origin of the product.

Samples
As a rule, when it comes to a domestic manufacturer, the registration of medical devices in Kazakhstan involves a laboratory stage (except in special cases). Imported MIs, depending on the country, sometimes do without providing samples. It is all about the paragraphs of the Order, which specify the cases when laboratory tests are not conducted. For example, the countries of the European Union are exempt from the analytical stage of examination, as well as manufacturers who have a certificate of full compliance of the quality system with European directives. And this is not the entire list of exemptions.

However, if the plant does not fall under any of the points stipulated in the Order, the expert body obliges to submit samples of the product for testing together with the dossier. This not only extends the examination period by a couple of months, but also requires a special permit to import an unregistered product into the country. For this purpose, the expert organization itself calculates the samples for free, it is only necessary to provide a quality standard, with requirements and methods for the product. But it should be borne in mind that if there are doubts about the quality of the product during the examination process, additional samples may be requested for retesting.

Site Audit

Among the additional costs beyond those outlined above, it should be kept in mind that there are a number of conditions when manufacturers are inspected. This does not mean that this requirement applies only to foreign manufacturers. Local factories are also subject to it. In order for auditors to visit the site, it is necessary to provide them with an interpreter, transfers, flights, accommodation and daily expenses. As a rule, at least two inspectors will visit, but depending on the scale of production, there may be as many as three. These costs are borne entirely by the applicant. A routine inspection is also required every three years.