Registry of Medical Devices

Notice on the upcoming end of the third transitional period according to the Act on Medical Devices

The State Institute for Drug Control informs on the upcoming end of the third transitional period according to Act No. 268/2014 Coll., on Medical Devices and on Amendments to Act No. 634/2004 Coll., on Administrative Fees, as amended i.e. March 31st, 2018.

According to Section 97 par. 5 letter c) of the Act No. 268/2014 Coll., on Medical Devices and on Amendments to Act No. 634/2004 Coll., on Administrative Fees, as amended (further referred to as "Act on Medical Devices"), a distributor or importer who fulfilled its notification duty set forth by Act No. 123/2000 Coll. and intends to continue to place on or supply to the market in the Czech Republic a medical device placed or supplied on the market in the Czech Republic thereby prior to the date of the coming into force of this Act and who is subjected to the notification duty pursuant to Section 33 shall be obliged to submit an application for notification of the said medical device no later then within three years of the date of coming into force of this Act where a risk class IIa medical device or a medical devices intended for self-testing is concerned, i.e. March 31st, 2018. 

Medical Device Branch 
6. 3. 2018

Registry of Medical Devices manuals:

 

Launch of the new Registry of Medical Devices, 04.05.2015

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...