SFDA’s Announcement For Extending Of Work Procedures For Medical Device Marketing Authorization (MDMA) requests
May 5, 2021
SFDA has recently published Extending Of Work Procedures For Medical Device Marketing Authorization (MDMA) requests; Click hereto read the official document.
Published on: 01st April, 2021
Highlights from this Document
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 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.
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