What does the cost of MI registration depend on?

How is the cost generated?

During the initial diagnosis, we always outline the approximate costs for the registration of medical devices. Because in addition to the standardized costs for services, there are always additional costs that need to be anticipated. The final cost of registration depends on the type of your product, of course. It also depends on which country it was manufactured in, which CE certificate the manufacturer has and even the address of the production site. Let's calculate together, so how much does it cost to register medical devices? We will talk on specific examples. So, the total cost will be formed from several components. The first is the price of the registration support service and the second is the fee for the registration of medical devices. Now let us understand what this consists of.

Let's break down the numbers

Let's take, for example, a more complicated product. Let's assume a sterile implantable MI, risk class 3, imported into the Republic of Kazakhstan for the first time. Let's assume that it is also produced in Kazakhstan. For comparison, we will quote the price for a foreign client as well

Support

The price includes initial consultation, complete collection of dossier up to readiness, submission of samples and project management in the state body, as well as obtaining a registration certificate. The cost of the service itself to support the registration work is approximately 2000 dollars (at lcs-kz)

Duties

The cost of the fee for the services of the National Center for Expertise of Medicinal Products and MI can be found in the service calculator on their website. The price can also be seen in the price list, in the section "Medical Devices". We choose expertise according to the national procedure, type - expert work for registration of MI, implantable products, without additional modification. We choose the cost for a domestic manufacturer. For our product the amount will be 77465.92 including VAT. If we choose a foreign manufacturer as an example, the price will increase many times and will be 472612.00 tg. Significant difference
Sites entering the market for the first time are subject to inspection by an expert body in certain cases. According to the price list at the moment, for risk class 3 the cost including VAT is 2,327,086 tenge. Plus, the host organization provides travel, accommodation, interpreter (optional) and daily expenses for at least two experts at its own expense. If we are talking about OTP, then these are some expenses, but if we are talking about a foreign manufacturer, then these are other expenses. Let us denote these costs as X
At the time of issuance of the registration certificate, the Committee's fee awaits us, which is 11 MRP for all.

Other unavoidable costs

Other unavoidable costs
Further, our product will require the provision of samples. The cost of this expenditure we cannot guess. But for domestic manufacturers, it is the cost of about 20 pieces. For a foreign manufacturer, it is the additional cost of obtaining a one-time import, as well as the cost of the samples themselves. Samples are provided with original markings, fully ready for consumption, having passed the entire cycle of the production process. Sometimes it is additionally required to provide standard samples and strains. Let us denote the cost as Y.
When collecting a dossier there are costs for notarization of some documents, as well as translation of instructions, layouts and for foreign - the dossier itself. Translation into the state language of instructions and layouts of MI costs in NCELS 2893 tg (including VAT), for one page. Foreign manufacturers translate dossiers also into Russian (provisions specified by the Order). On average, translation from English costs 2000-2500 Tg per translation page. For foreign producers it should be taken into account that apostilization/legalization of documents is also a paid service and varies from 300 to 1000 USD per document. Let us assume that these costs will be labeled as Z

What's the bottom line?

Total, we get, without economic accuracy, for OTP the price of 3,367,552+X+Y+Z, for foreign 3,762,698+X+Y+Z. The total cost is, of course, approximate. It depends on the factors mentioned above. But now you know what to base it on. The price will vary depending on the type of product, whether there will be an audit, whether there will be samples, etc. Another important point is that these rates are given for state registration, where the cost of laboratory testing is included in the examination. If we talk about the process within the union (EAEU), then the prices can safely be multiplied by two or three. In this case, product testing will have to be carried out separately, and this is a different story.