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Saudi Arabia: Updates on GHTF route acceptance, MD Regulation, MD advertising
- ARQon
- Jul 8, 2021
- 1 min read
Extension for acceptance under GHTF route applications
Submissions of MDMA (Medical Device Marketing Authorization) applications that depend on approvals from the GHTF (Global Harmonization Task Force) route has been extended to 1 July 2021.
The fulfillment of the technical file requirements for MDMA has been extended until 1 January 2022 6 months from the previous announcement.
Medical Device Regulation
The Medical Devices Interim Regulation has been replaced by the new Medical Devices and Supplies regulation.
It emphasizes the importance of obtaining market authorization for all medical devices. The authority may exempt some medical devices from the requirement to obtain a marketing permit, after ensuring their safety and not for commercial uses. The date of its implementation is 180 days from the date of publishing of the regulation.
Medical Devices Advertising Requirements
SFDA posted a guidance on Medical Devices Advertising Requirements (Arabic) on 18 May 2021.
Sources:
Contact us at info@arqon.com for more info
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