Alshedwy Group introduces its Saudi Medical Devices Authorized Representative and more regulatory services in Saudi Arabia Search Alshedwy Group EGYPT and Saudi arabia Regulatory Consulting for Medical Device and IVD Companies Need assistance complying with Saudi FDA (SFDA) medical device regulations?
medical devices / ivD DRC is a licensed Authorized Representative. According to the Saudi FDA regulations, overseas medical manufacturers must appoint a local Authorized Representative. The Authorized Representative will act as a communication channel between the manufacturer and the Saudi FDA. ...
Medical Devices Natural Healthcare Products Aesthetic and Cosmetic Products Nationwide Distribution & Global Partnerships: Locations: Riyadh & Khobar, Saudi Arabia Logistic Partners: Houston, TX, USA & Ottawa, ON, Canada Saudi FDA Licensed: Partnering with leading multinational corporations. ...
There is particular congruence with the approaches of the US Food and Drug Administration (FDA) and the International Medical Device Regulators Forum (IMDRF), but the SFDA goes beyond those approaches to incorporate other best practices into its guidance. Additionally, the binding nature of the MDS...
Classifications in the KSA are based on the classification within the founding GHTF country on which you’re leveraging your approval. How your medical device or IVD is classified in your GHTF reference market will determine how the Saudi FDA classifies your device in Saudi Arabia. ...
Announced FDA-cleared Irregular Heart Rhythm Notification (IHRN) feature on Galaxy Watch Developed industry-first GDDR7 DRAM, driving future growth of graphics market Developed industry-first LPCAMM form factor, transforming the DRAM market Received highest level of global certification from the Alliance...
Noul, a Korean diagnostic solution provider, has announced that it received marketing approval from the Saudi Food & Drug Authority (SFDA) for its AI-powered software medical device and cartridge designed to assist in malaria diagnosis in Saudi Arabia.Th
With the start of Saudi FDA in the past 10 years, the regulation of medical devices’ import has helped to reduce many of the challenges facing the proper acquisition of medical technologies. However, there are still many challenges facing CE in KSA similarly to other countries to be addressed...
this digital health collaboration incorporates Roche's expertise in medical devices and IT solutions with Glytec's FDA-cleared insulin dosing decision support software, Glucommander. Glucommander will be the first software program available for Roche's Cobas pulse smart-device next-generation hospital ...
(EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded...