As a "new thing", the relevant policies, standards and specification documents of UDI are not only numerous, fast updated and complicated to fill in, but also some provisions are not very clear. It is difficult for enterprises to comprehensively master and accurately interpret them in a short time through self-learning.

First, the national regulatory punishment is severe. In case of UDI non-compliance, a fine of up to 100,000 yuan may be imposed according to relevant regulations; second, UDI is linked to the production and sales of enterprises. Once the problem occurs, it may bring immeasurable economic losses.

Device companies generally have "small batches and many varieties," and some companies may even have thousands of SKUs, and need to design labeling and coding schemes for different product categories and packaging material characteristics. If the enterprise implements it by itself, it will not only take a long time, but also be extremely complex to manage.

The enterprise's UDI database is huge and the data will accumulate continuously, so the enterprise must establish a suitable data management system instead of relying solely on manual work, and need to connect with other systems to achieve unified data management.

The underlying framework of the UDI traceability system must be designed from the overall perspective, rather than focusing on the most basic compliance requirements at present; otherwise it will lead to uncontrollable costs and risks in the future.

As a professional traceability service provider deeply engaged in medicine for 16 years, Acctrue provides customers with intelligent services in the whole process from product production to patient use, and helps to improve enterprise management efficiency and digital upgrade.