{"id":18266,"date":"2021-05-26T09:29:01","date_gmt":"2021-05-26T07:29:01","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18266"},"modified":"2023-01-24T14:58:59","modified_gmt":"2023-01-24T13:58:59","slug":"taiwan-implementation-new-medical-devices-act-1-may-2021","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/05\/26\/taiwan-implementation-new-medical-devices-act-1-may-2021\/","title":{"rendered":"TAIWAN: implementation of the new Medical Devices Act on 1 May 2021"},"content":{"rendered":"\n

On 1 May 2021<\/strong> the Medical Devices Act<\/strong> entered into force, replacing the previous regulatory framework for Medical Devices<\/strong> in Taiwan<\/strong>.<\/p>\n\n\n\n

Consequently, the Taiwan Food and Drug Administration (TFDA)<\/strong> is issuing a series of guidance documents to provide information and clarifications to the Manufacturers and to other stakeholders.<\/p>\n\n\n\n

\"Taiwan
Implementation of the new Medical Devices Act on 1 May 2021<\/figcaption><\/figure>\n\n\n\n

What are the main novelties of the Medical Devices Act?<\/strong><\/h2>\n\n\n\n

The\nMedical Devices Act establishes a new regulatory framework for Medical\nDevices<\/strong> in Taiwan via a phased implementation schedule. <\/p>\n\n\n\n

First\nof all, one of the novelties is the new classification scheme for Medical\nDevices<\/strong>. As opposed to the previous one, the latter introduces 68 new device\ncodes, it removes two existing ones (E.0007 and F.3530) and it modifies the\nclassification of a further two (N.3045 e N.3070).<\/p>\n\n\n\n

This classification scheme is valid from 1\nMay 2021<\/strong>, with some postponements to 1 July 2022.<\/p>\n\n\n\n

Furthermore,\nthe Medical Devices Act confirms the main post-market surveillance measures,\n<\/strong>such as:<\/p>\n\n\n\n