Czech Republic Medical Device Regulation

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Czech Republic: New rules adopted for medical devices

https://www.lexology.com/library/detail.aspx?g=ccb9b415-555d-4768-9a19-c5940bfb15d0

Czech Republic March 2 2021 March 2021 – The Czech parliament has adopted local rules to implement the anticipated entry into force of a new EU Regulation on Medical Devices. The main...

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 …

Things for Registering your Medical Device …

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 …

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 …

Legislation of the Czech Republic, State Institute for …

https://www.sukl.eu/sukl/legislation-of-the-czech-republic

Decree No 54/2008 Coll., on the method of prescribing medicinal products, particulars to appear on medical prescriptions, and rules governing the use of medical prescriptions, as …

Czech Republic - Medical Equipment - International …

https://www.trade.gov/country-commercial-guides/czech-republic-medical-equipment

The Czech healthcare system is predominantly financed by the public sector through mandatory insurance contributions, private expenditures amount only around 2.8 …

Transformation of the Czech medical devices laws

https://www.peytonlegal.cz/en/transformation-of-the-czech-medical-devices-laws/

The proposed act regulates, inter alia, the powers of administrative authorities in the exercise of state administration in the field of medical devices, the National Information …

Czech Republic: Plans to regulate medical device …

https://insightplus.bakermckenzie.com/bm/healthcare-life-sciences/czech-repulic-plans-to-regulate-medical-device-advertising-over-and-above-the-mdrs-requirements

In relation to the adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive …

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