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Talking about UDI of Medical Devices
Release: Hexiang Packaging  Time:2021-09-14

1. What is a medical device traceability system?


The unique identification system for medical devices refers to a unified identification system for medical devices that is composed of a medical device's unique identification, a unique identification data carrier, and a unique identification database.


The so-called traceability system includes three parts: data information, information carrier and information storage.



Second, the unique identification of medical devices


Unique Device Identification (UDI) is an electronic ID card for medical device products.


01 DI (Device Identifier) ​​product identification


The product identification contains the information of the labeler and the product model. The product identification is a unique code that identifies the registrant or filing person of the medical device, the model, specification and packaging of the medical device.


02 PI (Production Identifier) ​​Production Identifier


The production identification includes the medical device serial number, production batch number, production date, expiration date, etc. The production identification is a code that identifies data related to the production process of a medical device.


(1) The manufacturer identification code consists of 7-10 digits, and the China Article Numbering Center is responsible for the distribution and management. The prefix assigned by the International Article Numbering Association to the Chinese Article Numbering Center is 690-699.


(2) The company compiles codes for products according to relevant requirements and product types, generally according to specifications/models.


(3) The check code is derived from the standard algorithm.


(4) PI production label is an optional item, and the content is determined by the enterprise based on the risk of medical device use and regulatory traceability requirements.


03 Preparation of UDI


The standards for the preparation of the unique identification of medical devices may include code-issuing agencies recognized by the State Food and Drug Administration or relevant standards formulated by the State Food and Drug Administration.


UDI is not compiled arbitrarily, and the UDI of the device is different due to the difference between the risk of medical device products and the regulatory traceability requirements.


Usually, the code issuing agency assigns a unique prefix to the medical device manufacturer, and on this basis, the manufacturer assigns a complete medical device unique identifier to the medical device product according to the standard of the code issuing agency.


 1) Mark to the specification model


UDI is only identified by DI and can be traced back to a certain model/specification of a medical device of a certain company.


2) Mark to batch


UDI is realized by the production date/expiry date and batch number in DI combined with PI. It can be traced back to XX batches of XX model/specification medical devices of XX company. One-dimensional barcodes are available.


3) Mark to single product


UDI is realized by DI combined with the production date/validity period and serial number in PI. It can be traced back to XX company XX model/specification XX medical devices.


For medical devices, most devices generally require traceability to batches. For high-risk products, such as pacemakers, traceability to a single product is required.


04 Basic principles of UDI


Uniqueness: The unique identification of medical devices should be consistent with the requirements for medical device identification.


 Stability: The unique identification of a medical device should be related to the basic characteristics of the product. If the basic characteristics of the product have not changed, the product identification should remain unchanged.


Scalability: The unique identification of medical devices should be adapted to the continuous development of regulatory requirements and practical applications.



Three, uniquely identify the data carrier


 The medical device unique identification data carrier is a data medium that stores and/or transmits the unique identification of a medical device.


Requirements are as follows:


01 The carrier can take the form of one-dimensional code, two-dimensional code or radio frequency tag. Currently, one-dimensional codes are still the mainstay.


02 When using one-dimensional codes, product identification and production identification can be connected in series, or multiple lines can be connected in parallel. When using radio frequency tags, one-dimensional code or two-dimensional code should be provided at the same time. At present, the one-dimensional code method in which product identification and production identification are connected in parallel is basically adopted.


03 The data carrier needs to be marked on the packaging or medical device products of the medical device sales units at all levels on the market, and the unique identification data carrier must be firm, clear and readable during the operation and use of the medical device.



Fourth, the only database


 01 Definition of medical device unique identification database:


The database contains the product identification and related data of medical devices.


02 Requirements for submission of unique identification data:


The registrant or recorder shall provide the product identification of the declared product in the registration/recording management system when applying for medical device registration or filing.


The registrant or the filing person shall upload the product identification and related data to the medical device unique identification database within 30 working days after the product is approved for registration, filing or modification.


During product registration/filing, the product identification of the declared product must be submitted at the same time, and the registration certificate must be obtained or it will be entered into the identification database after obtaining the filing. This means that the UDI of the product needs to be filed, just like the model specification, and cannot be changed at will. 

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