EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
Asia
The new article describes in detail the aspects related to registration that combination products should undergo in order to be allowed for marketing and use in the country. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the...
COVID-19
The article provides an overview of the existing regulatory framework and highlights the key points to be considered. Table of Contents Regulatory Background The present guidance covers the matters related to the 510(k) submissions for photobiomodulation (PBM)...
Saudi Arabia
The article provides an overview of the applicable regulatory requirements and highlights the key points associated thereto. Table Of Contents: The Saudi Food and Drug Administration (SDFA), a country’s regulating authority in the sphere of healthcare products, has...
Saudi Arabia
The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...
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