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Registration and Notification | NISZP
- https://www.niszp.cz/en/registration-and-notification
- Registration of persons handling Medical Devices and notification of Medical Devices in the Czech Republic after the date of application of MDR until fully functional EUDAMED …
Registry of medical devices | NISZP
- https://www.niszp.cz/en/registry-medical-devices
- The registry of Medical Devices shall mean pursuant to Act No. 268/2014 Coll. on Medical Devices and on Amendments to Act No. 634/2004 Coll., on Administrative Fees, as …
Things for Registering your Medical Device in Czech …
- https://www.regdesk.co/important-things-to-know-before-registering-your-medical-device-in-czech-republic/
- The State Institute for Drug Control, or Státní ústav pro kontrolu léčiv (SUKL) in Czech, is the …
Czech Republic Medical Device Registration - SUKL …
- https://arazygroup.com/medical-device-registration-czech-republic/
- In the Czech Republic devices are regulated by the SUKL – State Institute for Drug Control. CLASSIFICATION SYSTEM: Medical devices are classified according …
Czech Republic: New rules adopted for medical devices
- https://www.lexology.com/library/detail.aspx?g=ccb9b415-555d-4768-9a19-c5940bfb15d0
- At the EU level, on 26 May 2021, Regulation No. 2017/745 on Medical Devices (“MDR”) will enter into force. The MDR was adopted to increase both the safety …
Registry of Medical Devices, State Institute for Drug Control - SUKL
- https://www.sukl.eu/medical-devices/registr-zdravotnickych-prostredku
- 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, …
Act on Medical Devices, State Institute for Drug Control - SUKL
- https://www.sukl.eu/medical-devices/act-on-medical-devices
- This Act is a complex legal regulation which covers issue of Medical devices in the Czech Republic. Act covers following areas: TITLE I – INTRODUCTORY PROVISIONS TITLE …
Czech Republic - medecorp.cz
- https://medecorp.cz/en/placing-on-the-market-of-the-medical-device-czech-republic/
- Act No. 89/2021 Coll., on medical devices, is a regulation directly related to Regulation (EU) 2017/745 (MDR) and specifies the areas where Regulation (EU) 2017/745 gives …
Medical Device Registration in Czech Republic - Elsmar Cove …
- https://elsmar.com/elsmarqualityforum/threads/medical-device-registration-in-czech-republic.64608/
- Re: Cezech Republic medical device registration Dear Pads38, I've called the Directorate of Medical Devices in Czech Republic and told me that the …
Notification procedure of medical devices in Slovakia | ŠÚKL
- https://www.sukl.sk/en/medical-devices/instructions/registration-notification-procedure-of-medical-devices-in-slovakia?page_id=1718
- The manufacturer of medical devices class IIa, IIb and III, or authorized representative, who under his own name places medical devices on the market and/or puts them into service …
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