SFDA International Efforts to support countries in Medical Devices Regulation through Saudi FDA WHO Collaboration Centre for Medical Devices

4/12/2020
 
In the continuous international efforts for the SFDA WHO-Collaboration Centre of Medical Devices to help different countries in Medical Devices Regulation, Saudi FDA participated in a remote meeting with attendance of WHO-EMERO with WHO to discuss the potential opportunities of supporting the African medical devices forum (AMDF) and provide expertise in the medical devices area during this pandemic.
The meeting is chaired by WHO secretariat in Geneva with participation from different African countries (Ghana, Tenzania, Nigeria and South Africa) in addition to experts from Saudi FDA (Dr.Razan Assaly, Dr.Mohammed Majrashi and Ms. Fajer Alkusair). Saudi FDA participated in 4 working groups (WG1: COVID-19 IVDD tests (Mainly NAT assays), WG2 (Medical devices required during the COVID-19 outbreak including (PPE and ventilators)) ,WG3 (Medical devices Adverse events reports- Postmarket Surveillance) and WG4 (Guidance document in assessing MD and IVD tests donations during emergencies). Worth discussion and significant contribution was provided by Saudi FDA team including the sharing of SFDA approved IVDD tests list including EUA and MDMA, published guidance for medical devices reporting and Top 10 Risky medical devices based on the risk assessment approach.  Moreover, The SFDA will be in contact with the WGs and share any required documents or consultations through the WHO-CC.