Current development in medical devices postmarket surveillance in Taiwan

Current development in medical devices postmarket surveillance in Taiwan

The Taiwan Food and Drug Administration, Ministry of Health and Welfare (hereinafter referred to as the “TFDA”) ensures consistent and improvedmanagement ofmedical device safety. Medical devices usually refer to any equipment, software, or material intended to be used in the diagnosis, prevention, monitoring, or treatment of diseases or injuries [1]. Because of the increasing complexity of medical devices and the variability of usage environments, the concept of “total product life cycle” has been introduced during the product development phase [2]. Besides the strict regulatory framework to ensure the safety of both patients and health care providers, sustained monitoring and information collection are also crucial tasks to evaluate the safety and risk of marketed medical devices. Postmarket surveillance of medical devices includes reporting of adverse reactions and obligatory periodic safety update report for highrisk medical devices in the monitoring stage. All the current efforts on postmarket surveillance in Taiwan are aimed at implementing effective risk management and assessment controls and improving the protection for our citizens. Two online reporting systems are being established for sustained monitoring and collecting the safety information on marketed medical devices, namely, Adverse Events of Medical Device Reporting System and Defective Product Reporting System. In 1988, a nationwide reporting system of adverse drug reaction was set up. This network included one national center and four regional centers located in northern, central, southern, and eastern Taiwan. In 2001, the Adverse Events of Medical Device Reporting System was integrated into this system. To further harmonize data processing and enhance operational efficiency, the reporting network was subsequently centralized to establish the National Adverse Drug/Device Reaction (ADR) Reporting Center in 2005. In the same year, an online reporting system for medical product defect was also established. The defects may be attributed to manufacture, transportation, storage, distribution, and/or handling of the product, with the distinction that a product defect may or may not result in an adverse event (e.g., improper labeling). For the purpose of ensuring the quality of medical devices and preventing end users from possible hazards, voluntary reporting is encouraged when a product defect is found prior to use.