Asia
The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field safety corrective actions, and also the ones that are not subject to change notification requirements. Table of...
Asia
The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be considered in this respect. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere...
Asia
The article provides a brief overview of Singapore’s regulatory requirements in the sphere of change notification for medical devices. Table of Contents The Health Services Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
EU MDR/IVDR
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto. Table of Contents The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device...
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),...
