The SFDA has published MDS-G53, Guidance on Review and Approval of Artificial Intelligence (AI) and Big Data Based Medical Devices, which outlines the MDMA requirements relevant to AI-based medical devices. #TEXNICLE FILE SOFTWARE#Newly published guidance details evaluation of medical software using artificial intelligence (AI) and big data The SFDA additionally clarified that market authorizations issued under the GHTF route will remain valid until the assigned expiration date. However, the SFDA still reserves the right to request the Technical File (full or partial) if deemed necessary. This means that the Technical File Assessment (TFA) route remains optional at this time for products bearing such prior authorizations. The deadline for renewal and modification requests via the GHTF route, which was already set for January 1, 2022, has not been extended. The SFDA has again extended the date from which submission of Medical Device Marketing Authorization (MDMA) applications leveraging approvals from founding countries of the former Global Harmonization Task Force (GHTF) will no longer be accepted from Jto January 1, 2022. SFDA extends acceptance of MDMA applications using GHTF route to through 2021 The new regulation will take effect 180 days from the date of publication. It also allows the SFDA to exclude innovative medical devices from some of the conditions and procedures required to obtain market authorization. It reinforces the need for all medical devices to obtain market authorization, except certain devices identified by the SFDA to be demonstrably safe and not intended for commercial purposes. The new regulation retains most of the provisions of the interim regulation and serves as the fundamental basis of the SFDA’s authority to regulate medical devices. (M/54) (links in Arabic), approving the new overarching Medical Devices and Supplies Regulation to replace the Medical Devices Interim Regulation. The Saudi government issued Royal Decree No. Saudi royal decree establishes new medical device regulation Details follow in this roundup of recent Saudi regulatory developments. In related news, the Saudi Food and Drug Authority (SFDA) extended the use of the GHTF expedited market access route and published a guidance document on artificial intelligence in medical software and an updated classification guidance. The Kingdom of Saudi Arabia (KSA) officially introduced a new regulation governing medical devices, which is slated to take effect later this year.
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