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...
Asia
The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be considered in this respect. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere...
Asia
The new article provides additional clarifications regarding the regulatory matters related to post-market obligations, and distribution records, and also summarizes the regulatory requirements associated thereto. Table of Contents The Health Sciences Authority (HSA),...
Asia
The present article provides an overview of the regulatory requirements to be applied for the premises used for the distribution of medical devices. In particular, the article addresses the aspects related to the storage conditions required to ensure medical devices...
Ethiopia
The new article describes in detail certain specific aspects related to the labeling for medical devices intended to be marketed and used in Ethiopia, including the way the labeling should be placed and the information it should contain. ...
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
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