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

Shanghai has began to implement class Ⅲ medical device UDI since 2007, which provide precious experience for China medical device UDI regulation and implementation. Improving the quality of medical device and increasing communication between MAH and end user are two methods to improve end user safety for MAH to choose, which can be realized by medical device UDI (Meidical Device Unique Device Identification). To realize medical device UDI, which is 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 item (smallest sales item) 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 coding 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 China medical device compliance

Although China medical device UDI regulation is introduced years later than pharmaceutical Track & Trace regulation started in China, the experience from Shanghai implemented medical device UDI and the serious life threating caused by wrong usage of class Ⅲ medical device will push the medical device regulation implementation even quicker than pharmaceutical Track & Trace regulation to implement in China. 

Timeling from NMPA, 

• From October 1, 2020, manufacture need to implement medical device UDI on all of the medical product for the first batch of implemented product catalogs;

•  The Rules for Unique Identification System for Medical Devices and the deployment of the Pilot Work Plan for Medical Device Unique Identification System, the medical device unique identification database was officially launched on December 10, 2019, with functions opened to pilot enterprises to apply for related data of unique identification of pilot varieties.

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 - YOUR MEDICAL DEVICE INFORMATION MANAGER

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 both domestic and international UDI declaration and all-level of label design, and docking with production line (include code print on unit, camera, labeller, etc.) with user friendly interface. Supporting all types of serialization and aggregation to improve production efficience.

Serialization & Aggregation - YOUR MEDICAL DEVICE QUALITY SAFEGUARD

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 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 trace basic information with 4W (what, when, where, why). The TE Device to prevent illegal opening before it is opened by end user. Aggregation is assign 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 - YOUR MEDICAL DEVICE LOCATION TRACKER

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

The smallest sales unit is 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 code printing and inspection line of code printing, inspection, labeling, sealing whether semi-automatically or automatically under ISO standard.

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