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.
- 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