Asia
The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
Asia
The article provides an overview of the regulatory requirements related to the content of special communications to be issued by medical device manufacturers in order to inform about the issues associated with the products they are responsible for. Table of Contents...
Asia
The document highlights the key points related to the regulatory requirements for handling complaints associated with medical devices allowed for marketing and use in Singapore. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in...
Asia
The article provides an overview of the regulatory requirements for medical device recalls. Table of Contents The Health Sciences Authority (HSA) has published a guidance document dedicated to medical device recalls. The document provides additional clarifications...
Asia
The new article highlights the aspects related to field safety corrective actions including, inter alia, the record-keeping requirements, and publication of field safety notices informing the parties involved about the safety-related concerns identified and...
Asia
The new article highlights the aspects related to the risk management process for the supply of medical devices. Table of Contents The Health Sciences Authority (HSA),Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
