Medical Device Manufacturers the world over are striving to stay abreast of developments as regulatory bodies other than the US FDA release details concerning their approach to Unique Device Identification for medical devices. Taiwan is progressing in the area of UDI, having produced a guidance document late last year.
Within this guidance information it is clear that Taiwan’s Unique Device Identification:
- References both the US FDA UDI Rule and the IMDRF UDI Guidance
- Will use a Taiwanese version of the FDA GUDID which will be called the UDID
- Provides guidance on combination products
- Targets Medical Devices that are manufactured in Taiwan and ones that are imported
- Allows various forms of AIDC and recommends the use of human readable characters
- References the use of GS1, HIBCC and ICCBBA
- Recommends direct marking for medical devices which are to be reprocessed
- Provides guidance that applies to software as a medical device (SaMD)
Although the tone has been set and many details are available, there is still much information that is yet to be put forth. Specifics about UDI attributes to uploaded and maintained as well as standards for the transfer of attribute information will go a long way towards helping the medical device manufacturing community assess the magnitude of the regulatory challenges that lie ahead.