FDA officially issues regulatory rules for unique identification code of medical device UDI

September 22, 2013 source: minenet devices group minenet September 22 (Tang Ziqin) on Friday, FDA officially issued the world-renowned regulatory rules for medical devices, requiring relevant products to be marked with unique identification code (UDI) After the implementation of UDI rules, device products will be more easily tracked, monitored and recalled The UDI system consists of two core parts The first part is the unique identification number of the device, which is assigned by the global coordination group (GHTF) These numbers include batch number, model, production date, expiry date and other information They are in the form of number, scannable barcode and English text, and are managed by the device manufacturer The second part is a database that can be queried publicly, in which other data except patient information can be retrieved and managed by FDA Once the new rules are fully implemented, the products circulating in the market will be identified quickly and efficiently This means two aspects: 1 The patient's EMR will show which device is used This will improve the reporting quality of adverse events, accelerate product recall and ensure the safety of patients It also helps with the settlement of medical insurance 2 The distribution network of device products will be included in the database In case of problems, the products in stock can also be recalled quickly On the other hand, it can also prevent fake and inferior products from entering the market The FDA says the data on the distribution network will be global In the 2007 Revision of the federal food, drug and cosmetic law, UDI has been explicitly included in the regulatory agenda Due to the huge cost of compliance for some manufacturers, the government and the business side have been working for many years In July 2012, they issued a 120 day consultation draft, and then continue to postpone it FDA made some concessions in the final version of the rules Most high-risk implantable devices, such as pacemakers and defibrillators, will first be regulated by UDI Low risk products will be exempted from some or all UDI, such as bandages and other large packaging products will use a UDI code together (for detailed rules, please click https:// after the implementation of UDI, medical device supervision will enter a new era of informatization and traceability CFDA will fully implement the drug electronic supervision in 2015, which is similar to UDI rules The difference is that one is medicine, the other is more complex medical devices, and the UDI system can be publicly queried