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 (hereinafter referred to as the “ZoVZP”) shall be submitted through the Information System for Medical Devices (hereinafter referred to as “ISZP”).

Access to ISZP, settings and video manuals can be found on the UZP Important Links page.

Notifications are continuously processed according to Part Seven of the ZoVZP and the reported medical devices are classified into reimbursement groups according to the Categorisation Tree.

The Categorisation Tree is part of Annex No. 3 of the ZoVZP.

Processed and completed notifications are the basis for the generated List of all medical devices reimbursed on the basis of prescriptions by voucher („List of MD“).

According to Section 39s, paragraph 1 ZoVZP, the Institute publishes on the tenth day of a calendar month on the official electronic noticeboard of the Institute all notifications pursuant to Section 39r, paragraph 2 delivered to the Institute in the previous calendar month, provided that they contain all the data pursuant to Section 39r, paragraphs 5 and 8.

How often is the Institute publishing the List of MD?

The list of MD is published every month. The current List of MD is available:

• in a PDF version on the Institute’s official notice board (Czech only)
• 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 they can receive reimbursement as part of their inclusion in group 11 – uncategorized medical devices. To be included in this group, the Institute must submit a written consent from the Ministry of Health – medical devices will be reimbursed up to 50% of the final price or a risk-sharing agreement concluded with all health insurance companies – medical devices will be reimbursed in full. More information can be found here. Further information you can read on Group 11 – Non-categorised Medical Devices[MF2] .

How can patients participate in the updates of the categorization tree?

Through the Commission for the Categorization and Reimbursement Regulation of Medical Devices. The Patient Council of the Ministry of Health, the National Council of Persons with Disabilities and the Coalition for Health are represented here. This commission prepares an update of the categorization tree every year, which is subsequently approved by legislators in the form of an amendment.

How often is the categorization tree updated?

The law cannot determine the frequency of its own amendments, an amendment to the law is currently being prepared.

Where can I find the Categorisation Tree?

The Categorisation Tree is currently available in Annex No. 3 to the ZoVZP, Section C, Table No. 1. (Czech only)

Should the trade names of medical devices be translated into Czech?

The trade name once determined by the manufacturer should not be subsequently modified in any way or translated by him without authorization. Some trade names do not have a linguistic connotation, while others do. If the manufacturer himself creates various “linguistic mutations” of the trade name for different target countries, this is his full right (e.g. he names the same medical device differently, while the difference between these names is given by a simple translation). SÚKL will assess the compliance of the trade name specified 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 clinical evaluation report).

The declaration of conformity attached to the notification may be issued in Czech or English in accordance with the law. If the declaration of conformity is issued in English, its translation into Czech is not required.

However, the instructions for use must always be in Czech. Nevertheless, achieving agreement on the trade name should not cause difficulties for the notifiers.

Must translations of documents into Czech be officially verified?

The Institute accepts documents submitted in the official language (Czech, Slovak, tolerated English) and in other cases requires a simple translation into Czech (this does not apply to the instructions for use).

How long does the Institute have to process new notifications? The Institute must publish all notifications that meet the content requirements of the law received in one month, including attachments, by the 10th day of the following month. Subsequently, the general professional and lay public has enough time to point out any errors in the notification. This period is generally 45 days. After the deadline has expired without initiating administrative proceedings for the non-inclusion of the medical device in the reimbursement group, the Institute must include the given medical device in the next draft list of MD.