switzerland The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
FDA The first article provides an overview of the approach applied by the FDA to applications for marketing approval for new medical devices in terms of determining their substantial equivalence to the products that are already present on the market. Table...
FDA The article describes in detail the way the medical device manufacturer may apply for exemptions from general reporting requirements, as well as the information to be included in the appropriate request. Table of Contents The Food And Drug Administration (FDA...
Asia The first article highlights the most important aspects related to the application for medical device registration and the way it should be submitted. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
Africa The second article in our series covering EDA guidance on unique device identification, this article focuses on aspects related to the importation and delivery of medical devices. It also provides the definitions of the most important terms and concepts used in the...
