Aug 18, 2022
FDA
The new article provides the details regarding the troubleshooting information to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
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Aug 17, 2022
Asia
The article provides an overview of the regulatory requirements in the sphere of distribution practices for medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a...
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Aug 17, 2022
FDA
The new article highlights the key points related to the reports of prior investigation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
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Aug 16, 2022
Africa
The present article describes in detail the decision-making process to be followed when determining the regulatory nature of the changes and further steps to be taken. In particular, the document addresses the aspects related to the changes to the design of a medical...
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Aug 16, 2022
FDA
The present article provides additional information regarding the details to be reflected in medical device patient labeling for operations of the product. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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Aug 16, 2022
EU MDR/IVDR
The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the existing regulatory framework. In particular, the article addresses the matters related to the pre-assessment...
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