Asia
The new article describes in detail the good assembly practice principles to be applied for medical devices and also provides additional clarifications regarding the traceability-related matters to be considered. Table of Contents The Health Science Authority (HSA),...
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 new article highlights the main points related to the secondary assembly of medical devices intended to be marketed and used in Australia. In particular, the document addresses the assembly area requirements, storage conditions, and labeling. Table of Contents...
Asia
The new article describes in detail the requirements associated with the special pathways to be used to make unregistered medical devices available for healthcare professionals and patients. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
Asia
The article describes in detail the aspects related to the delivery, installation, and servicing of medical devices and key points to be considered in this respect. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
