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

Further to the previous Announcement (1) 12/2020, Receiving new
marketing authorization requests via the GHTF route will be extended
until (01/07/2021) AD. According to Royal Decree No. (M / 54) dated
06/07/1442 AH and the Council of Ministers’ Resolution No. (377)
dated 04/07/1442 AH which approved the medical device law

SFDA would like to inform about the following:

• Extending work procedures for medical device, the fulfillment of the technical file requirements for medical device Marketing Authorization (MDMA) for a period of six months from the previous announcement (until 1/1/2022 AD), Please note that SFDA has the right to request the technical file or part of it whenever needed.
• The validity of Medical Device Marketing Authorization (MDMA) issued in accordance with the current Medical Devices Interim Regulations will be valid until its expiration.