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Regulatory requirements of IVD and SaMD

Regulation of Software as a Medical Device

In today’s digital world, technologies and software play an increasingly important role in healthcare management - diagnosis, treatment, patient monitoring and utility of Real World Evidence. Some of these innovative technologies include softwares and health applications that either work independently or support a medical device. The unique features of these Software as Medical Device (SaMD) set the differentiation on how it should be regulated compared to traditional medical devices.  This course aims to provide a better understanding of the regulations for SaMD, including requirements for safety assessments, that will aid in the development, market entry and utility of SaMDs.  

Programme Overview

  • Relevant regulations, guidelines and standards for managing SaMD in the region
  • Concepts on the testing and technical document requirements for SaMD, as well as the concerns and challenges
  • Key considerations for SaMD development and change management[/ACCORDION]

Regulation of In Vitro Diagnostic Devices

In Vitro Diagnostic (IVD) devices are a key component of healthcare, and pivotal to advancing technology solutions for patient centric care, such as personalized medicine. These devices are not limited to only healthcare professionals’ use, but some are also widely and directly available for consumers. This highlights the importance of effective regulation of IVD, ensuring their safety, quality and performance in supporting the healthcare system, patients and consumers. This course will provide a fundamental understanding of the principles behind effective regulation of IVD devices, and cover an overview of the technical documentation and available international standards. This enables an informed decision when planning for the development, market entry and management of IVD devices.

Programme Overview

  • Risk classification profiles of IVD by key regulatory bodies - IMDRF, EU IVDR, ASEAN and US FDA.
  • Requirements, standards and regulations applicable for IVD
  • Key considerations for IVD development and change management[/ACCORDION]

Post-market vigilance: Regulatory activities for monitoring IVD and SaMD

As new medical devices and technologies enter into the healthcare system at an exceedingly fast speed, it is important that the safety, quality and effective performance of these innovations comply with required standards throughout their product life cycle. Coverage of safety starts from the designing of the medical devices. Thus, having good post-market vigilance practices is essential to safeguard the public health. This course aims to provide an overview of the post-market processes for monitoring the safety and effective performance of medical devices, including healthcare softwares and applications, as well as complying with requirements for changes and updates to the products after regulatory approvals. Participants will have an insight into the interactions among regulatory organisations that guide professionals for good practices in post-market surveillance.

Programme Overview

  • Managing field safety corrective actions (FSCA) and adverse events
  • Relevant standards and guidance required in post-market vigilance
  • Documentation requirements in supporting good practices for post-market activities