The Health Science Authority (HSA) has published updated versions of several pre-market registration-related guidance and technical reference documents. These documents pertain to all general and in vitro diagnostic medical devices. Specifically, there was an added requirement as listed in the Common Submission Dossier Template (CSDT) of the ASEAN Medical Device Directive (AMDD). The mentioned documents are:

  • - GN – 15 Guidance on Medical Device Product Registration (R7.5)
  • - GN – 17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT (R1.1)
  • - GN – 18 Guidance on Preparation of a Product Registration Submission for In – Vitro Diagnostic Medical Devices using the ASEAN CSDT (R1.1)
  • - TR – 01 Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT (R1.3)
  • - R – 02 Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT (R1.2)

For GN-15, 17, 18, TR-01, and TR-02, the evidence to support the cybersecurity was added to the requirements in the summary of design verification and Validation, design verification and validation reports, and risk analysis report.

In summary, the major updates to the documents are all about the addition of cybersecurity requirements. As advancements in medical devices become more relevant and the industry of Software as Medical Device (SaMD) continues to grow rapidly, it is very important that these devices are cyber-secure.

References: 

GN – 15 Guidance on Medical Device Product Registration

GN – 17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

GN – 18 Guidance on Preparation of a Product Registration Submission for In – Vitro Diagnostic Medical Devices using the ASEAN CSDT

TR – 01 Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

TR – 02 Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices   using the ASEAN CSDT

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