Poland Medical Device Registration

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The Office | Urząd Rejestracji Produktów Leczniczych, …

https://www.urpl.gov.pl/en/office

In accordance with the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Journal of Laws 2011, No …

New Polish Act on medical devices - Part Three - Taylor …

https://www.taylorwessing.com/en/insights-and-events/insights/2022/05/new-polish-act-on-medical-devices-part-3

Local registration of economic operators and medical devices. The current Polish regulations provide for a fairly broad system of local registration of medical …

Medical devices - PCBC S.A. - Polish Centre for Testing …

https://www.pcbc.gov.pl/en/services_/product-certification/medical-products

We are a notified body with the identification number 1434 assigned by the European Commission, in the field of medical devices, among others. We have the …

Polish Regulation on Medical Devices: an …

https://www.regdesk.co/polish-regulation-on-medical-devices-an-overview/

Jul 7, 2020. The Office for Registration of Medicinal Products, Medical Devices, and Biocidal …

Poland Medical Device Registration and Approval

https://arazygroup.com/medical-device-registration-poland/

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities.The Polish Ministry of Health (MOH) must also be notified of all …

New Polish Act on medical devices - Part Two - Taylor …

https://www.taylorwessing.com/en/insights-and-events/insights/2022/04/new-polish-act-on-medical-devices-part-2

Part Two of our guide to the Poland’s Act on Medical Devices takes a practical look at the most important detailed regulations which go beyond the scope of …

Medical Device Registration in Poland - omcmedical.com

https://omcmedical.com/medical-device-registration-in-poland/

Medical device registration in Poland is carried out according to general and simplified procedures. The approval for a drug, medical equipment and medical methods …

Regulatory, Pricing and Reimbursement Overview: Poland

https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-poland/

Act of 7 April 2022 on Medical Devices (“Act on Medical Devices“), as well as a number of supplementary laws thereto, establish the main regulatory framework for …

Registration under national procedure | Urząd Rejestracji …

https://urpl.gov.pl/en/biocidal-products/biocidal-products-registration/registration-under-national-procedure

Payments from Poland: 21 1030 1508 0000 0005 5000 0070 All documents in foreign languages require a sworn translation into Polish, as Polish language is the …

Pharmaceutical & medical device advertising regulation …

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/poland

The Polish legislator has decided to regulate the advertising of medical devices more broadly than the regulations adopted by the EU. Rules relating specifically to the …

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