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Establishing the Medical Devices Act and Creating a New Industry Era 【Date:2018-11-28】 unit:醫療器材及化粧品組

Medical devices have become highly related to the lives of people across Taiwan. In addition to shouldering the responsibility of ensuring the safety, effectiveness, and quality of medical devices, the Taiwan Food and Drug Administration (TFDA) is also one of the vital enablers for the development of medical device industry in Taiwan. With the rapid progress of science and technology and the advent of population aging around the world, demand for medical devices is increasing substantially, thereby driving a boom in the global medical device industry. In response to international trend and in line with Taiwan’s five-plus-two industrial innovation program and New Southbound Policy, the Medical Devices Act was drafted at an opportune time, with a view to opening a new chapter for Taiwan’s medical device industry to enter the international arena.

The benefits of establishing the Medical Devices Act are threefold-internationalization, soundness, and specialization. As the separate management of drugs and medical devices has already become an international trend, this Act is harmonized with laws and regulations in various countries around the world, so that Taiwan’s medical device industry is able to connect seamlessly with global countries. To address a diverse range of medical devices and a wide variety of research and development (R&D) and manufacturing processes, regulatory mechanisms would be enhanced based on the life cycles and risk management principles of each type of product. For instance, new systems such as a registration system to be implemented for low-risk medical devices, and the flexible approval of permit validity period, will not only accelerate the time to market for products and bring benefits to patients, but also drive the development of industry. In addition, the new Act will list those who design medical devices and launch such devices to the market in their own names as manufacturers. This not only protects the interests of designers, but also encourages the industry to invest in R&D. Using the Medical Devices Act as a single source of law would allow for the planning of medical device regulatory system as a whole and the governance from design, manufacturing, and all the way to distribution and use.

Establishing the Medical Devices Act not only improves various measures that enhance the safety, effectiveness, and quality of medical devices for safeguarding the health and safety of the public, but also serves as an endeavor to improve the quality of domestic medical device industry, strengthen international cooperation, as well as offer regulatory consultation and counseling of industry projects, thereby assisting businesses in going international. At present, the draft has been reviewed by the Legislative Yuan. The TFDA will strive to improve the Act and actively communicate with all sectors. It looks forward to garnering support from all stakeholders in the hope that this Act can be officially implemented as soon as possible, and that a new era can be created for the development of Taiwan’s medical device industry.