“One code for one device” - the general trend

The unique identification (UDI) of medical devices is the "ID card" of medical devices, the "international language" and "common language" of medical devices, and is also a global policy trend. Major countries and regions including China, the United States and Europe are actively promoting the construction of the unique identification system of medical devices, and creating a "new infrastructure" for medical device management and security.
Based on 16 years of excellent advantages and rich experience in the field of medical traceability, Acctrue Technology can help the majority of medical device enterprises to build a “one code for one device” UDI traceability system, which not only meets the national regulatory requirements and realizes the whole life-cycle management of medical devices, but also enables enterprises to upgrade the digital lean management of the whole supply chain.

Why is it recommended to choose Acctrue professional service provider to implement UDI?

Difficulty in policy learning

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.

High risk of implementation trial and error

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.

Complex coding label design

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.

Difficulty in data management

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.

Uncontrolled future risks

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.

High added value of digital intelligence application

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.

Medical device UDI overall scheme planning

More compliant, convenient and versatile one-stop service

Compliance consulting service

Provide UDI professional compliance consulting and training services for domestic and overseas medical devices in China, the United States and Europe

DI filing and uploading

Customized coding scheme, PI batch generation, connection to the UDID database of the National Medical Products Administration of China, DI one-key declaration, data two-way synchronization

Connection to overseas database

Support the connection to the US GUDID platform and the EU EUDAMED platform to meet the UDI compliance requirements for products exported to Europe and the United States



Label cloud printing

UDI label template online design, online printing, label database batch maintenance

Production line coding association

Provide software and hardware integrated coding products with independent intellectual property rights, customize the coding landing scheme, and verify the rich experience and strength of 20000+ production lines transformation

IT system connection

Support the connection to ERP/WMS/MES and other internal information systems of enterprises, break the data islands, and achieve unified data management

Convenient stock-out/in management

Provide the handheld terminal scanning stock-out/in APP, and realize the scanning and convenient stock-out/in management in the whole process of production, circulation and sales based on the UDI coding information

Anti-counterfeiting and anti-channeling management

Accurately control product flow data based on UDI, more effectively implement anti-counterfeiting and anti-channeling management, and improve channel control

Computer system verification (CSV)

Fully meet the regulatory requirements of GMP/GSP, 21CFR Part 11, Annex 11, etc. on computerized systems

Connection to the national medical insurance platform

Connect to the medical insurance platform to realize the function of automatically uploading the medical insurance consumables classification and code database

Terminal enabling control

Provide diversified terminal services such as stock-sell-storage management, code scanning inventory, code scanning settlement based on UDI, and enable enterprises to improve terminal marketing power through various digital strategies

Patient digital service

Support the connection to Tencent Medical Kit, reach patients efficiently through WeChat "Super Entrance", and provide authoritative medical services for drug use, drug inquiry and drug purchase

Data report visualization

Provide diversified data reports based on DI product master data and dynamic service data to support enterprise decision-making

Patient anti-counterfeiting traceability query

Support diversified patient query functions such as anti-counterfeit verification and tracing

Scheme advantages

Multi-code compatibility, medicine and device tracking

Acctrue Technology is a GS1-based traceability cloud platform service provider in the medical industry in China, and can manage multiple products in a unified way based on the same platform, and realize the collaborative management of multi-code coexistence and drug and device tracing;

Open up medical insurance for authentication and verification

It can be connected to the medical insurance authentication and verification system, open up the hospital HIS system, realize medical insurance premium control, and traceable flow;

Connection to overseas platforms and global tracing

It can be connected to US GUDID and EU EUDAMED platforms to provide overseas compliance guarantee for export products;

Open up WeChat and serve patients

Acctrue Technology cooperates with Tencent Intelligent Medicine strategically, supports to connect to "Tencent Medical Kit" products, and provides patients with diversified pharmaceutical services based on the WeChat "Scan" super entrance, laying a good foundation for enterprises to open up the patient-side data path.

Connect us to start "one code for one item" digital and intelligent growth

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