Welcome to Medical Regulations Gate
Medical Regulation GateMedical Regulation GateMedical Regulation Gate
(Sat - Thursday)
Kingdom of Saudi Arabia
Medical Regulation GateMedical Regulation GateMedical Regulation Gate

Requirements

  • Home
  • Tag: Requirements

SFDA’s Announcement For Extending Of Work Procedures For Medical Device Marketing Authorization (MDMA) requests

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…
Read More

SFDA’s Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices

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…
Read More

SFDA’s Requirements For Safe Use Of Mammography

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…
Read More

SFDA’s Requirements For Safe Use Of Medical Ultraviolet Radiation

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…
Read More