On 1 May 2021 the Medical Devices Act entered into force, replacing the previous regulatory framework for Medical Devices in Taiwan.
Consequently, the Taiwan Food and Drug Administration (TFDA) is issuing a series of guidance documents to provide information and clarifications to the Manufacturers and to other stakeholders.
What are the main novelties of the Medical Devices Act?
The Medical Devices Act establishes a new regulatory framework for Medical Devices in Taiwan via a phased implementation schedule.
First of all, one of the novelties is the new classification scheme for Medical Devices. As opposed to the previous one, the latter introduces 68 new device codes, it removes two existing ones (E.0007 and F.3530) and it modifies the classification of a further two (N.3045 e N.3070).
This classification scheme is valid from 1 May 2021, with some postponements to 1 July 2022.
Furthermore, the Medical Devices Act confirms the main post-market surveillance measures, such as:
- Serious adverse events reporting;
- Medical Devices Recalls;
- Further measures for the surveillance of safety aspects.
Lastly, the Medical Devices Act outlines the UDI requirements related to the creation and application of the information on the unique identification of the Medical Device. According to these requirements, the UDI information must be affixed on the body of Class II and III Medical Devices or on the individual packages.
The UDI information must be uploaded to a dedicated database.
The proposed timelines for mandatory implementation of UDI requirements are the following:
- June 2021 – Class III high risk implantable devices;
- June 2022 – Class III non-implantable devices;
- June 2023 – Class II moderate risk devices.
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Sources:
Reporting serious adverse events
