The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
On 05 November 2020, the TFDA published a new draft guidance document for public consultation.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”.
On 10 August 2020 the NMPA launched Unique Device Identification (UDI) Database on its website.
UDI data compliance adds an additional layer of complexity to an already resource stretched team. Managing the regulatory data across regions, languages, timezones and facilities without a robust and efficient process is not sustainable. Non-compliance is not an option.
Human families come in all shapes, sizes, colours, genders and ages. However; in the case of medical device categorisation, the definition of a “family” of product codes is entirely up to you…