Presentation (CTI)

OBJECTIVES: Medical devices are increasingly important in Vietnam as healthcare demand rises alongside population ageing and non-communicable diseases. Despite recent developments, assessment and processes for management of medical device remain complex, especially for external stakeholders. This project aimed to provide an initial overview of the current landscape and identify opportunities for more value-based and evidence-informed decision-making.
METHODS: A descriptive synthesis was conducted, combining a focused review of publicly available legal, policy, technical, market, and international reference documents with qualitative insights from expert engagement. Thirteen individual consultations were conducted with experts from regulatory agencies, health insurance, hospitals, procurement, academia, and the medical device industry. A multi-stakeholder roundtable was convened to validate and contextualize emerging findings.
RESULTS: The pathway can be understood as a lifecycle process involving market entry, technical and clinical introduction, approval of new procedures, procurement, reimbursement assessment, and post-market surveillance. Key challenges include lack of a sufficiently detailed identification system and integrated whole lifecycle database, which constrain traceability, reimbursement management, and value-based decisions; lack of clear criteria and methods for value-based assessment in procurement and reimbursement; and complex management of repeatedly used or reprocessed devices. Strategic solutions include (i) a comprehensive, standardized unique device identification system and integrated database; (ii) value-based evaluation methods and criteria, clearly distinguishing between procurement objectives and reimbursement objectives, with a tiered and flexible approach tailored to different technology groups and implementation capacities of institutions; (iii) selective use of international evidence; (iv) strengthening central management and coordination while allowing sufficient regional flexibility; (v) transitioning from document-based management toward digital system management, and (vi) specialized unit for health technology assessment.
CONCLUSIONS: A more integrated, lifecycle, and value-based approach could support transparent, evidence-informed decisions while improving access to innovation, affordability, safety, and sustainability.