It is common for entrepreneurs to work with Contract Research Organizations (CROs), to conduct clinical investigations of digital medical devices if these cannot be conducted in house. Such cooperations might contribute to speeding up the processing of applications for the authorisation to conduct clinical investigations for the development of new digital health solutions. A-Pharma and Cepha are the main CROs in the country. 

Click here to obtain more information on clinical assessments through CROs

The State Institute of Drug Control registers and performs checks of subjects active in medical devices, including manufacturers, importers, distributors and entities providing service of the devices. You can access the registry online. This is a public administration information system intended for the collection of data about medical devices placed on the market in the Czech Republic.

There are various procurement and purchasing models for medical devices. However, if the device is expected to be reimbursed by the public insurance fund, you must submit your application to the General Health Insurance Company (VZP) that performs all assessments and authorizes the reimbursement. To validate your application for reimbursement, you must submit different documents to the department of medical devices.