ablcc_newsletter-4th-edition-2021_A5_04

33 SAUDI ARABIA: NewSFDA (Saudi Food and Drug Authority) rules regarding market access procedure New medical Devices Regulation was approved in February 2021 by the Royal Decree No.(M/54) and entered effect in July 2021. According to the new directives, any national or foreign manufacturers of medical devices will have to register or renew their licenses on the new GHAD platform (https:// ghad.sfda.gov.sa/en) . Those new measures are followed by an increase in registration fees. There will also be more technical files to provide to prove the conformity of medical devices. You can find more information about required documents and procedures on the following two links: • (SFDA Recognized Standards) https://old.sfda.gov.sa/ar/medicaldevices/ regulations/DocLib/MDS%E2%80%93G44.pdf • (MDS-G43. Guidance on Innovation Medical Devices) https://old.sfda.gov.sa/ar/ medicaldevices/regulations/DocLib/MDS-G43.pdf Sources: https://www.thema-med.com/en/saudi-arabia-new-market-access-procedure-medical-devices- coming-soon/ and https://www.s-ge.com/fr/article/actualites/20211-c3-arabie-saoudite-nouvelles-regles- medtech-limportation EGYPT: Nominee to host the 27th edition of the UN COP27 in 2022 As one of the largest and most important international events, the 27th edition of COP27 will be held in Sharm-el-Sheikh, where more than 10.000 thousand participants will be represented. This choice is to award Egypt for its effort in preserving the environment and fighting climate change. Some of the areas that where targeted included the power generation projects from renewable and green sources, rationalization, and enhancement of energy efficiency activities. Egypt is strongly working on a plan for climate change adaptation and implementation of sustainability standards. Sources: https://dailynewsegypt.com/2021/10/04/egypts-sharm-el-sheikh-to-host-un-climate-summit- cop27-in-2022/