Digital healthcare in the Czech Republic

Key figures

10.5 M

inhabitants

7.8 %

of GDP earmarked for healthcare spending in 2019

7

public health insurance funds

The State supports advances in medical technology to ensure the sustainability of its healthcare system

The government's multi-year e-health strategy 2016-2026 supports the digitalization of the healthcare system

How do I access the Czech market?

1. Perform a clinical assessment (optional)

It is common for entrepreneurs to work with contract research organizations (CROs) to conduct clinical investigations on digital medical devices if these cannot be carried out in-house. These cooperations could help to accelerate the processing of authorization applications, to conduct clinical investigations for the development of new digital health solutions. A-Pharma and Cepha are the country's leading companies.


Click here for more information on clinical evaluations through CROs.

2. Register the medical device with the National Institute for the Control of Medicines.

The National Institute for Drug Control registers and verifies manufacturers, importers, distributors and entities that supply medical devices. A public administration information system is available online, designed to collect data on medical devices placed on the market.

3. Submit an application for reimbursement of the device to the VZP's Department of Medical Devices (ODZP).

There are different methods for obtaining reimbursement for a medical device. However, if the device is to be reimbursed by the public insurance fund, you must submit your request to the general health insurance company (VZP), which carries out all assessments and authorizes reimbursements. To validate your claim, you must submit different documents to the medical devices department.

Test and experimentation structure (TEF)

The University of Brno is one of the European partners in TEF-Health, which aims to enable large-scale testing of artificial intelligence software and robots in realistic environments

.