Early December last year, the Saudi Food and Drug Authority (SFDA) released the Announcement (1) 12/2018 containing the latest updates on Medical Device Marketing Authorization (MDMA) procedures. Being effective January 1st, 2019, Medical Devices Marketing Authorization (MDMA) certificates will be valid for a maximum period of three (3) years, considering the validity of the conformity certificates issued by recognized international bodies if it is less than three years. However, new products will not be able to be added when applying for a Medical Devices Marketing Authorization (MDMA) certificate renewal.
Furthermore, with the aim of ensuring appropriate demonstration of safety and effectiveness of Medical Devices and IVDs, and as a result of the SFDA undertaking the issuance of approval for conducting Clinical Investigations and Clinical Evaluation. The Saudi Food and Drug Authority (SFDA) has been recently working on guidance documents for Medical Devices Clinical Investigations (Guidance on Requirements for Clinical Investigations of Medical Devices, issued December 26th) and IVDs Performance Evaluation Studies (Project of Guidance on Requirements for Performance Evaluation Studies of In Vitro Diagnostics Medical Devices, published as a draft and under consultation since December 26th, too), in order to clarify the requirements for conducting Clinical Investigations of Medical Devices (CIMD) and Performance Evaluation Studies of IVD Medical Devices (PESIVD) within the Kingdom of Saudi Arabia (KSA).
Also, later before the end of the year, a Project of Guidance on Post-Market Clinical Follow-Up Studies was released as a draft and under consultation, with the purpose of providing assistance on planning to prepare and design Post-Market Clinical Follow-Up studies related to collect and submit clinical data for Medical Devices, in order to investigate and assess the residual risks of devices already placed on the market.
Besides, the SFDA recently touched base on another hot topic, Patient-matched Medical Devices using 3D printers, and adopted the document “Handbook for Approval of Patient-matched Medical Devices Using 3D Printers (AHWP/WG1/F001:2017)” published by AHWP on November 21st, 2017, to provide recommendations related to the approval process and procedures for Patient-matched Medical Devices using 3D printers.
Magellan Device Compliance Platform is abreast of the latest updates in the Medical Device and IVDs sector worldwide, please contact our team and join us at Arab Health, the Largest Healthcare Exhibition in GCC (Dubai World Trade Centre, from 28 – 31 January 2019), to know more details on how Magellan can assist you implementing all of them!