NMPA “Rules for Unique Device Identification (UDI) System” Issued on August 27, 2019 mandates that the China UDI system for the first group of devices will take effect on October 1, 2020.. Timeline. In this paragraph, we will talk about the update of ISO 15223-1 that will introduce new symbols to add in the labelling of medical devices. The UDI system aims to improve patient safety, modernize postmarket device surveillance, and facilitate medical device innovation. a UDI applied to a medical device anywhere in the world should be able to be used globally and to meet the UDI requirements of its regulatory authority, c. national or local identification numbers should NOT be a substitute for UDI, d. regulatory authorities should not specify the procedure for modifying these UDI … Following the global trend in handling the traceability of medical devices, the EU Commission has clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, published at the beginning of May. Unique Device Identification (UDI) The U.S. Food and Drug Administration (FDA) created unique device identification, often abbreviated UDI, a rule that requires medical device manufacturers to update their products with a unique device identifier that includes both device and production identifiers (such as expiration date and lot or serial number). Aggregation refers to creating a parent-child hierarchy between different levels of product packaging, starting from a product unit up to a pallet. Medical device classes are defined by the FDA as Class I, Class II, and Class III to indicate lowest to highest risk should a device … The UDI must be both human-readable and in a form that uses automatic identification and data capture (AIDC) technology. The EU, as chair of the International Medical Device Regulators Forum (IMDRF) working group on UDI, strongly contributed to the preparation of the international guidance on a unique device identification system for medical devices, which was adopted in December 2013.. Aggregation of Medical Devices. Reprocessed and Single-Use Devices. Other countries are adopting the UDI system as well. Moreover, the manufacture needs to keep up-to-date a list of all UDIs that is has assigned. The UDI Final rule requires medical device labels to contain a UDI, unless exempt or provides for an exception or alternative placement. Although not mandated by UDI requirements, aggregation of medical devices is another pillar of optimal medical device traceability. The manufacturer should ensure that all information required is correctly submitted to the UDI database (European Database on Medical Devices – EUDAMED). The Unique Device Identification (UDI) System intends to assign a unique identifier to medical devices within the United States and Europe. ISO 15223-1:2020 new symbols for medical devices. An UDI shall be attributed to a medical device created before placing such device on the market. The FDA is establishing the unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use. Specifically, along with ISO 20471, the new ISO 15223 is a fundamental standard to support the manufacturers in preparation of labelling and accompanying documents. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI)..
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