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...
Asia
The new article highlights the aspects related to the specific associated with certain types of medical devices, including consumer-level and implantable ones. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
Asia
The new article covers the aspects related to the application of the reliance approach to specific categories of healthcare products and also provides an overview of the reliance procedures. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a...
Asia
The new article highlights the aspects related to the content of reports to be submitted by the parties involved at different stages of the process. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare...
