Mar 6, 2023
Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
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Mar 2, 2023
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...
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Feb 28, 2023
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...
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Feb 28, 2023
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...
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Feb 23, 2023
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...
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Feb 20, 2023
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...
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