FDA
The new article highlights the aspects related to design considerations in the part of risk management. The document also provides an overview of the most important terms and concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
HSA
The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...
FDA
The article highlights the key points related to the regulatory status of the products in question and describes the approach to be followed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Canada
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
