Asia
The article highlights the key points related to internal audits and outsourcing activities. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the...
Asia
The new article highlights the approach to be applied concerning counterfeit medical devices, as well as the way the parties involved should handle complaints related to medical devices they are dealing with. Table of Contents The Health Sciences Authority (HSA),...
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...
