Information for Notifiers
Notifications to the system of Categorisation and price and reimbursement regulation of medical devices prescribed on a voucher pursuant to Part Seven of Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended, shall be submitted through the Information System for Medical Devices (hereinafter referred to as “ISZP”).
How often is the List of medical devices covered by a voucher issued by the Institute?
The list of medical devices covered by a voucher is issued on a monthly basis. The current List can be found in a PDF version here, in machine-readable CSV data in the public part of the ISZP.
What is the procedure for medical devices for which there is no reimbursement group?
These are not reimbursed, but may receive reimbursement under the so-called non-categorised medical device group. To be included in the group of so-called non-categorised medical devices, the Institute needs to submit a written approval from the Ministry of Health – the devices will be reimbursed up to 50% of the final price or a risk-sharing agreement concluded with all health insurance companies – the devices will be fully reimbursed. Further information can be found here.
How can patients participate in updates to the categorisation tree?
Through the Commission for Categorisation and Reimbursement Regulation of Medical Devices. The MoH Patients’ Council, the National Council for Persons with Disabilities and the Coalition for Health are represented here. This Commission prepares an annual update of the categorisation tree, which is then approved by the legislators in the form of an amendment.
How often is the categorization tree updated?
The law cannot determine the frequency of the actual amendment; an amendment to the law is currently pending.
Should the trade names of medical devices be translated into English?
Once a trade name has been designated by the manufacturer, it should not be subsequently modified or translated in any unauthorised way. Some trade names do not have a linguistic colouring, others do. If the manufacturer itself creates different “linguistic mutations” of the trade name for different target countries, this is its full right (e.g. naming the same medical device differently, the difference between these names being due to a simple translation). The CMA will assess the consistency of the trade name given in the notification with the trade name in the attached regulatory documents issued by the manufacturer (e.g. declaration of conformity, instructions for use or final report of the clinical trial).
The Declaration of Conformity accompanying the notification may be issued in Czech or English, as required by law. If the declaration of conformity is issued in English, no translation into Czech is required.
However, the instructions for use must always be in English. Nevertheless, achieving conformity in the trade name should not cause difficulties for notifiers.
Do translations of documents into Czech have to be officially certified?
The Institute accepts documents submitted in the official language (Czech, Slovak, tolerated English) and in other cases requires a simple translation into the Czech language (does not apply to the instructions for use).