HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
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...
HSA
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
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),...
