Some of you may remember the Taiwan Food and Drug Administration (TFDA) Unique Device Identification (UDI) Guidance published on 30 October 2015 which kick started the voluntary UDI pilot programme.

On 05 November 2020, the TFDA published a new draft guidance document for public consultation. The guidance ​​document, “Requirements for the Single Identification Code to be Published on the Labels of Medical Devices”, outlines new requirements for the creation and application of UDI information for the medical devices and in vitro diagnostics under TFDA regulation. As the draft document is open to public consultation, concerned parties now have until 04 Jan 2021 to provide feedback via the channels listed below:

  • Webpage of the “Health and Welfare Law Search System” or “Public Policy Network Participation Platform-Zhongkai Talking”
  • Food and Drug Administration, Ministry of Health and Welfare

No. 161-2 , Kunyang Street , Nangang District, Taipei City

Tel: (02)27878289

Fax: (02)26532006

  • Email: vv741121@fda.gov.tw

The draft guideline pronounces the following requirements:

  • The single package or device body of Class II and Class III medical devices should be marked with a unique device identifier (UDI); if the single package or the device is too small, the UDI should appear on the smallest saleable unit.
  • The owner or registrant of the medical device license shall upload the product corresponding information (see below Table I) of the identification code to the TFDA medical device identification system database
  • The following medical devices are exempt from marking UDI:
    • Personalised devices
    • Special devices for export only
    • Medical devices and in vitro diagnostic medical equipment that are non-implantable medical equipment components for single use only and are not used separately and sold.

The draft also states that the coding principles will generally follow the International Medical Device Regulators Forum (IMDRF) recommendations.

Similar to other regional UDI database requirements, the owner or registrant of the medical device license shall register on the UDID platform before the device enters the market. If a device change results in an updated DI, the owner or registrant of the medical device license, must upload the new DI and corresponding information into the UDID prior to the new product entering circulation.

Mandatory implementation for Class III implantables to begin 01 June 2021.

Table I: Information to be provided to TFDA UDID

Timelines and data exchange requirements to meet the ever evolving global UDI obligations must be captured in your regulatory assessment and regulatory strategy communications.

kimyoung@instem.com

K Young

References

Photo by Charlie Solorzano on Unsplash