The Legislative Yuan passed the 3rd reading of the “Medical Device Management Act”, which separates the regulations on medical devices from the Pharmaceutical Affairs Act. The Medical Device Management Act also includes new regulations about the track-and-trace system, the electronic registration of low risk devices, flexible license periods, manufacturers’ obligation of reporting, etc. The Act aims to accelerate the launch of new products, benefit patients, support the development of the industry and create a robust management system for medical devices.
Wu Hsiu-Mei, Director General of the TFDA, expressed that, as the technology advances and the society is ageing, the high demand on medical devices has pushed the development of the industry. In Taiwan, medical devices are within the scope of the government’s “5+2” Policy and the new Southbound Policy. This Act will usher the medical device industry into the global markets.
The Act contains 85 Articles. The highlights are:
- To encourage the R&D and innovation of the industry: New medical device designers will be considered to be medical device manufacturers and entitled to R&D and innovation incentives. The Act provides the legal basis for the accelerated launch and other supporting measures for advanced medical devices.
- To improve the management of diversified technologies: Providers of medical device maintenance services and the suppliers of certain medical devices are brought into the scope of the Act.
- To improve the management of medical device manufacturers: The Act not only regulates the manufacturing and the selling of medical devices, but also demands the establishment of the track-and-trace system, the QA system and the distribution management system.
- To implement the risk-based management: Some low-risk medical devices are subject to electronic registration, of which the validity can be extended via the submission of annual reports.
- To protect trial subjects’ rights: The Act regulates the clinical trials of medical devices. Investigators should report adverse reactions detected during a trial, and suspend or terminate the trial if there are safety concerns. The Act also stipulates that it would not be necessary to apply for an approval for clinical trials of non-significant risk devices as specified by the competent authority.
- To strengthen post-marketing safety monitoring: Certain high risk medical devices are subject to post-marketing safety surveillance in order to ensure the quality and safety of medical devices. Healthcare providers should comply with this requirement. Manufacturers should carry out a risk management program on every product on the market, and take corrective or preventive measures if necessary.
【2019-12-13 / MOHW】
