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Announced the Guidance for the Management of Additive Manufacturing (3D Printing) Medical Devices 【Date:2018-01-18】 unit:醫療器材及化粧品組

Recently 3D printing technique has been widely discussed in the manufacturing of medical devices in the world, and Taiwan is no exception. For the health and safety concern, Taiwan Food and Drug Administration (TFDA) has announced a guidance "Guidance for the Management of Additive Manufacturing (3D Printing) Medical Devices" on January 12 in 2018 to clarify the scope of managing 3D printed medical devices and regulations, and to promote the development of related industries. This guidance is referred to all relevant regulations in the world and a deep consideration of the current development of related industries in Taiwan. The guidance includes the scope of application and the principles of regulatory classification for 3D printed medical devices. In particular, considerations for software workflows, quality control, process control and final product test of 3D printed medical devices are specified in the content. The guidance could also help manufacturers in the aspect of providing technical data of 3D printing, often referred to as Additive Manufacturing, for example, what information TFDA would recommend manufacturers to include on submissions for 3D printed medical devices.

As a new type of manufacturing skills, 3D printing has the great advantage of the ease in fabricating complex geometric structures and facilitating the creation of anatomically matched devices and surgical instrumentations. According to the reports of medical devices development in the world, many countries have started to approve 3D printed medical devices in the fields of orthopedics, dentistry, supportive device and accessory. 3D printing could help manufacturers bring their products to market more efficiently when a transparent process for future submissions is provided. For all submissions, a principal concept for TFDA’s consideration is that 3D printing is just the processing method and it should not alter the function of final products. Final products ought to comply with all the requirements of existing relevant laws and regulations of the Pharmaceutical Affairs Law.Although there is a huge diversity of 3D printing, this guidance firstly provides a principled management suggestion to ensure the safety and effectiveness of medical devices. TFDA expects to accelerate 3D printed medical devices into the market through the regulatory announcement, and aims to establish a quality environment for industrial development to promote Taiwan's medical devices worldwide.