Nov 17, 2020
The Taiwan Food and Drug Administration (TFDA) published a draft guidance document (link in Chinese) for public consultation on November 5. The guidance outlines new requirements relating to the creation and application of Unique Device Identification (UDI) information for medical devices and IVDs.
Under the new requirements, Class II and III medical devices and IVDs will need to be labeled with UDI information on the body of the product itself or on individual packages. In cases where the product is too small for this condition to be feasible, the UDI labeling may be applied to the smallest unit of bulk packaging used for sale. The guidance also lists certain types of products that are exempt from UDI labeling requirements, including personalized medical devices.
The TFDA will require UDI information for products to be uploaded to a dedicated database, here referred to simply as the UDI Database or UDID. Two annexes to the guidance provide details on the composition of product numbers and bar codes, along with requirements for their inclusion in the UDID.
The proposed timelines for mandatory implementation of UDI requirements are as follows:
The TFDA will be accepting public feedback for 60 days from the date of publication of the draft guidance. Contact information is provided in the announcement.
The Taiwan Food and Drug Administration announced that it will cease conducting on-site inspections for overseas companies during the COVID-19 health crisis, replacing previously scheduled inspections with document reviews.
The TFDA documents provide information on submitting Periodic Safety Update Reports and serious adverse event reports, and are offered for public consultation.
Other countries that plan to adopt the legislation or align elements of their own regulatory systems with it must now decide how to proceed.