State Institute for Drug Control (SUKL), the Ministry of Health (Ministry of Health) and the Coordination Centre for Departmental Medical Information Systems (KSRZIS) inform the public about the launch of the public Registry of Medical Devices (RZPRO).
On 1 May 2015 a new Registry of Medical Devices was launched. (RZPRO is a public administration information system specifically designed to collect data on medical devices registered and placed or made available on the market in the Czech Republic).
The public part of the databaze
The public part of the database is for informational purposes only. Anyone can easily verify whether a person has fulfilled the reporting obligation in relation to his activities or the requirement to report a medical device placed or made available on the market. A legal deadline of up to three years (depending on the risk class of the medical device) applies to the obligation to populate the database with information on medical devices. The public part of the database allows full-text searches of persons, medical devices and Field Safety Notices published since 1. 5. 2015. Previously published Field Safety Notices are available on the website of the State Institute for Drug Control here.
Access for notifiers and professionals
RZPRO aims to provide the competent authorities with rapid access to information (registered in the Czech Republic) about products, authorized representatives, importers, distributors, persons engaged in servicing medical devices, sponsors of clinical trials and Notified Bodies for medical devices, certificates issued by Notified Bodies, on incidents and corrective measures and to data on clinical trials, in order to increase the safety and effective sharing of relevant information between concerned government authorities in the field of medical devices in the Czech Republic.
Persons who notified the Ministry of Health according to the legislation effective before 1. 4. 2015, are considered as registered in accordance with § 26 of the new law on medical devices. If you have complied with this requirement, please wait until you receive the access information to your user account in the unified management of users EREG; access information will be sent on 30. 04. 2015 to data boxes and on 15. 5. 2015 by registered mail addressed to your own hands.
- Access to RZPRO for experts and notifiers (the "Login" in the upper left corner)
In case that you, as a handler of medical devices did not notify your activity to Ministry of Health under the legislation effective before 1. 4. 2015 or you carry out a new activity, ie. after 1. 4. 2015 continue to request access to RZPRO.
Technical support is provided by KSRZIS where you can address any questions regarding the application support through: helpdesk.registry@ksrziscz or by calling the telephone number +420 261 092 462.
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Relevant government authorities
- State Institute for Drug Control (SUKL) http://www.sukl.cz
- Ministry of Health http://www.mzcr.cz/
- Office for Standards, Metrology and Testing (ÚNMZ) http://www.unmz.cz
Updated information regarding the legislation on medical devices can be found here.
Medical Devices Branch
19 May 2015