PMCF is a continuous process that updates the manufacturers' clinical evaluation during the Post-market surveillance....
IMDRF guide on Post Market Clinical Follow-up Studies (PMCF)
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Medical Device Registration in Saudi Arabia
Medical Device Registration Saudi ArabiaMinistry of Health: Ministry of Health Regulatory Authority: ...
UDI DI
UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally...
Cosmetics Registration in Saudi Arabia
Cosmetics Registration in Saudi ArabiaRegulatory Authority: Saudi Food and Drug Authority (SFDA) Link for RA:...
Saudi Arabia
Saudi ArabiaSaudi Arabia Medical Device Regulations Regulatory Authority: Medical Device Sector, Saudi Food & Drug...
April Newsletter 2023
Germany Database for In vitro diagnostics medical devices notification | 25 April 2023 In Vitro Diagnostic Medical...
Regulatory Services in China
OMC MedicalRegulatory ServicesSubscribeEU MDREU MDR, or the European Union Medical Device Regulation, is a new set of...
SFDA Classification of Medical Devices
The medical devices regulatory framework has a classification system for medical devices as per the classification...
March Newsletter 2023
EUROPEAN UNION (EU) Guidance on MDR transitional period extension | 28 March 2023 The amendment of the MDR and of the...
Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices
According to European Union Medical Device Regulation (EU MDR) the term “Vigilance” is the identification, reporting...
Translation
Global Translations ServiceTypes of Translation OMC offersTranslation Overview The world does not speak one language,...
February Newsletter
EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The MDCG 2023-3...