August 17,as held in Hangzhou,the eighth China Medical Device Supervision and Management International Forum (CIMDR) one of the main sub-forum,the only device logo and the global medical device nomenclature forum to attract the relevant regulatory authorities, Industry experts and a large number of multinational companies and related areas of business leaders concerned.

In the Forum,the State Food and Drug Administration Director of the Department of Medical Device Registration Management,said the national medical device unique identification project is a significant work, in order to successfully promote and implement the need for the parties to its necessity and importance  to form a correct cognition.

Countries concerned the UDI

UDI(Unique Device Identification) is the identity of the medical device in its entire life cycle,is its product supply chain in the only "identity card."In addition to meeting the visible requirements,UDI must meet the form of plain text and have automatic recognition.

UDI consists of the device identification code (DI) and the production identification code (PI).DI is a static information,it is the medical device products in the supply chain identity,can be used as a database query the product to trace the basic information keyword;and PI is a dynamic information,which includes medical device product serial number,batch number,The date of production and the validity period,etc.is the dynamic information of medical device products,which is used in conjunction with DI to point to specific medical device products.

At present,some international regulators issued UDI regulations,the use of UDI to carry out supervision of medical devices.According to reports,in 2013 the US Food and Drug Administration (FDA) issued a UDI regulations,requiring the establishment of UDI logo medical device regulatory system.

All Class II medical devices and packaging entering the US market prior to September 24,2016 must have a UDI logo and must be entered in the Global Device Identification Database (GUDID) for data on Type II medical devices.

In May 2017 the EU issued a new version of the MDR regulations,introduced the concept of medical devices using UDI and the requirements of the European Medical Device Database (EUDAMED) registration and uploading documents.Some countries,such as Turkey,South Korea,India,have put UDI regulations on the agenda.

2016 Director General on the promotion of food and drug manufacturers to improve the traceability of the system pointed out that to encourage drugs, medical device manufacturers on the product of the smallest sales unit assigned to a unique identity,so that operators, consumers identify to ensure that Product traceability.In the unique logo on the legal system to reach a consensus to encourage the medical device manufacturers to give a unique product logo.

UDI promotes global standardization management.

UDI identification is being gradually accepted,although it will increase investment for medical device manufacturers,but it can not be ignored that its important protection for patient safety and the regulatory role of internationalization of medical devices are increasingly being influenced by Attention.

The main significance of using UDI is the identification of products and the establishment of traceability system.If the world can adopt a unified,standard UDI,can greatly improve the industry chain transparency and operational efficiency,effectively reduce the operating costs of multinational companies to achieve the information in the product life cycle sharing and exchange,but also conducive to business Events to monitor and recall the product, to ensure the safety of patients with medication.

In the product trade has long been a breakthrough in the national and regional boundaries of the international trade environment, the instrument unique logo for patients and businesses around the world are of great benefit.