Requirements

SFDA has recently published Extending Of Work Procedures For Medical Device Marketing Authorization (MDMA) requests; Click here to read the official document. Published on: 01st April, 2021 Highlights from this Document Introduction Further to the previous Announcement (1) 12/2020, Receiving newmarketing authorization requests via the GHTF route will be extendeduntil (01/07/2021) AD. According to Royal…

SFDA has recently published Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices; Click here to read the official document. Published on: 27th April, 2021 Highlights from this Document Scope This guidance applies to the standalone software type of medical devices, to which machinelearning-based AI technology is applied, that…

SFDA has recently published Requirements For Mammography; Click here to read the official document. Published on: 12th January, 2021 Highlights from this Document Introduction Mammography is an effective method for screening breast cancer. However, there are safety implications of mammography equipment as they utilize X-rays, which are potentially dangerous, to produce images. Screening mammography services…

SFDA has recently published Requirements For Safe Use Of Medical Ultraviolet Radiation; Click here to read the official document. Published on: 12th January, 2021 Highlights from this Document Introduction Ultraviolet radiation (UVR) is the band of non-ionizing radiation that lies between the ionizing radiation and the visible radiation (light) electromagnetic spectrum. The UVR wavelength range…