Registration of maximum prices

There is a misconception that the life cycle of a medical device is completed by obtaining a registration certificate. However, after gaining access to the market, manufacturers face other procedures. And all of them are in one way or another related to the registration process. And in this article we will talk about the service - registration of price limits for medical devices.

This service is new relative to others in the post-marketing period and is provided by the national center of expertise according to the order KR-DSM-247/2020.

The purpose of this service is to determine the maximum allowable purchase price for items and equipment purchased with budgetary funds.

What's important to consider?

First of all, it is important to realize that, price caps on medical devices are set for a specific type of medical product version or unit of medical equipment. For this purpose, during the initial diagnosis, specialists LCS-kz It is mandatory to check the variations section of the state register, where all variations must be listed separately.

Secondly, only one item can be specified in one report, so in case of different prices, it is impossible to include several models in the general report. In such a case it is necessary to make changes in the reg dossier beforehand and only then to submit for approval of the price.

On the corporate website of the company in the section LCS blogThere is an article on the topic "How to prepare an application correctly", where there are recommendations on how to specify the execution options. The article will be useful both for the first time filling and for checking existing projects.