UDI system (Ramz) aims to documenting unique devices codes for medical devices based on accredited international standards, in purpose to allow all stakeholders to identify medical …

2022年6月16日 · SFDA in vision 2030 . Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; ... (UDI) for Medical Devices (MDS – REQ …

This document aims to identify SFDA requirements of Unique Device Identification (UDI) for medical devices. The purpose of UDI requirements and its database is to provide standardized …

The DM UDI may be: Identical to the UDI that appears on the label of the device, or A different UDI used to distinguish the unlabeled/unpackaged device. You can choose more than one …

UDI system (Saudi- DI) aims to record and document the identifier codes for medical devices based on international standards. Device (DI) codes will help the users and stakeholders to …

2020年9月17日 · The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of medical devices in Saudi Arabia, has published a guidance document dedicated to the …

2024年6月11日 · SFDA 要求沙烏地阿拉伯的所有醫療器械公司都遵守唯一設備標識 （UDI） 法規。 他們必須在 SFDA UDI 系統中註冊其商品的 UDI 資訊。 這些法規根據設備風險等級逐步執 …

2019年11月12日 · UDI Parts. 1. Device Identifier (UDI-DI): a unique numeric or alphanumeric code specific to a device and that is also used as the "access key" to information stored in a …

2023年10月19日 · 在沙特阿拉伯，自 2023 年 9 月 1 日起，制造商必须实施唯一设备标识 (udi) 要求，才能将 b、c 和 d 类设备投放到该地区的市场上。 对于 A 类设备，该义务将于 2024 年 9 …

2024年6月8日 · SFDA requires compliance with the Unique Device Identification (UDI) regulations on all medical device companies in Saudi Arabia. They must register their product’s UDI …