Global Medical Device UDI

All-in-one solution based on Track & Trace for global medical device UDI compliance 

Improving the quality of medical device and increasing communication between MAH and end user are two common methods that MAH to choose to improving end user safety, which can be realized by medical device UDI (Meidical Device Unique Device Identification). To realize medical device physical secure on production, transportation, management, and safe to use, Track & Trace solution/solution based on unique code on batch level with DI (Device Identifier) is the way of implement global medical device UDI compliance. Furthermore, implementing  PI (Production Identifier) on each unit (smallest sales unit) can provide more information about end user to form product and patient information integration. Combined JawaSoft's Track & Trace and NT-UDI is the solution for China medical device UDI compliance in one production line by code printing and aggregation on packaging. JawaSoft can provide all-in-one service in production which against lifescience threating; the production line upgrading or customized will improve competitiveness from brand reputation, production efficiency, future expansion and implement informatization under big data era.

Track & Trace project in global medical device compliance

The categories of medical device products involve a wide range, and the packaging forms are diverse in specifications, and various types / languages of use method and introduction need to post on the package. Although the traceability regulations related to medical devices have begun in 1990s, the development on medical device growth too quickly to finalize the regulation in few years and implemente the regulation as pharmaceutical compliance. Therefore, the medical device regulations issued by various countries are gradually implemented according to the classification of medical devices.

Medical device UDI is the solution for:

• Driven by interests, counterfeit products on the market cannot be effectively verified in time, and inferior products cannot be accurately recalled and processed;

• In the case of rapid product updates or different production countries and sales countries, many products cannot be used accurately, resulting in medical accidents;

• When the feedback from the end user cannot be obtained, the product quality cannot be accurately improved, similar use errors cannot be avoided, and the required product type cannot be developed in time.


NT-UDI is a solution of UDI management for global medical device UDI information interaction.

JawaSoft patented platform (SaaS) NT-UDI could manage huge amount of data in easy way. NT-UDI could provide international UDI declaration and all-level of label design, and docking with production line (include coding unit, camera, labeller, etc.) with user friendly interface. Supporting all types of serialization and aggregation to improve production efficience.


Serialization & Aggregation software is a solution for anti-counterfeiting on each sales unit/batch.

Global medical device UDI compliance is aim to avoid wrong usage and prevent the unqualified product cannot recall on time caused life threatening. Many countries require serialization and aggregation for each batch-level of medical device to be traceable from manufacture to end user as regulation required. 

Serial number (in form of barcode/Data Matrix/RFID) on each unit (e.g. item, bag, kit) package need be both AIDC and HRI, and it is unique in the world to be traceable basic information with 4W (what, when, where, why) . The TE Device to prevent illegal opening before it is opened by end user. Aggregation is assigned relationships between packaging levels (item/bag/kit, bundle, box, pallet), which from lower packaging level to higher level or through several packaging levels to ensure each item is tracable and the record about product can be traced for years.


Track & Trace is a solution for batch-level of product traceability and anti-channeling.

The smallest sales unit is required to code print and inspect under high speed to qualify traceability requirement and high volume production requirement. For any type of complicated production line, JawaSoft can provide efficient solution on coding and inspection line of code printing, inspection, labeling, sealing whether semi-automatically or automatically under ISO standard.

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