MRG

Unlocking the Future of Regulatory Compliance in Saudi and MENA region with MRG! MRG is excited to exhibit at the China International Import Expo (CIIE) from November 5th to 10th at Booth SA16. Join us to discover our latest regulatory services and solutions designed to stay compliant and ahead in today’s fast-evolving global marketplace. #CIIE2024 #RegulatoryExcellence #MRG #ComplianceSolutions #GlobalTrade

Egyptian Drug Authority (EDA) Announces an 18-Month Extension for Certain Human Pharmaceutical Products. The Egyptian Drug Authority (EDA) is granting an 18-month grace period for specific human pharmaceutical products that have exceeded the required timelines for submitting their complete final registration files. These products will not be eligible for further extension and must meet production requirements in line with Ministerial Decisions No. 296 of 2009 and No. 425 of 2015. Companies have 60 days from the date of this announcement to submit an application to the General Administration for Human Drug Registration to request approval for the extension. Extension Details: A grace period of 18 months will be granted, provided the full CTD (Common Technical Document) file is submitted according to WHO and ICH requirements, along with the service fee. Products failing to submit the extension request within the 60-day timeframe will have their registration process cancelled. Read the official announcement: https://lnkd.in/d73WTbhz EDA Submission link: https://lnkd.in/dVQ7aKc4

We are thrilled to have had such an amazing last day at the #globalhealthexhibtion. A huge thank you to all our clients, partners, and visitors who stopped by our booth. Connecting with each of you, sharing insights, and discussing future opportunities was the highlight of our event. We are excited about the possibilities that lie ahead and look forward to continuing our journey together. #medicaldevices #globalhealth #regulations #consultation #success #mrg

Marking the first day at the #globalhealthexhibition, we are pleased to invite you to visit us at Booth H1B-Z20. Our team of experts is available to provide strategic insights and regulatory support, reflecting our role as a leading healthcare consulting firm. We look forward to discussing how our services can drive your organization’s growth and success in the ever-evolving healthcare industry. #globalhealth #medicaldevices #events #informa #regulations

MRG is thrilled to announce that we will be exhibiting at the Global Health Saudi Exhibition! Visit us at Booth H1B-Z20 to explore our services and solutions and connect with our experts. 📅 Event Dates: 21to 23 October 2024 📍 Location: Malham, Riyadh, Saudi Arabia We look forward to seeing you there! #MRG #GlobalHealthSaudi #SFDA #MEDICALDEVICES 

The Saudi Food & Drug Authority (SFDA) has issued key updates to the Clearance Conditions & Requirements Guidelines (V2.0) for pharmaceutical and health products. Key Highlights: FASAH Document Retention: Importers must now retain FASAH documents for 5 years. Packaging Size: Registered medicines cannot be released if their packaging size differs from the registered specifications. Sample Analysis: When samples are taken for analysis at the importer's expense, the importer must cover the testing costs to avoid shipment delays, violations, or fines. Shelf Life Reduction: The SFDA has reduced the minimum acceptable shelf life from 70% to 50% to meet market demand. However, this update does not apply to tender shipments and direct purchase orders, which follow their own regulations. kindly find below announcement: https://lnkd.in/dMhWh9x3 #MRG #SFDA #RegulatoryUpdates #Pharmaceuticals #Compliance #MedicalDevices

The Saudi Food and Drug Authority (SFDA) is proud to announce joining the International Medical Device Regulators Forum (IMDRF). This strategic move reflects the SFDA's commitment to fostering collaboration and alignment with international standards and practices in the regulation of medical devices, based on its Fourth Strategy, which aims to enhance international leadership. Read the full announcement here: https://lnkd.in/grewr5fW #MRG #MedicalDevices #Regulation #SFDA #IMDRF #RegulatoryAffairs #MedicalDeviceRegulation

Announcement from the Egyptian Drug Authority (EDA) The Central Administration for Biological Products and Innovative Medicines, along with Clinical Studies, is pleased to announce the release of the first edition of the "Guideline for Preclinical Testing and Clinical Investigation for Medical Devices." This initiative reflects EDA's commitment to continuously align with the latest scientific advancements, ensuring the availability of innovative products with advanced technologies while guaranteeing their quality, effectiveness, and safety. The official announcement: https://lnkd.in/d7Rk5sxt The guideline: https://lnkd.in/dkaJpuGS #MRG #MedicalDevices #RegulatoryAffairs #EgyptianDrugAuthority #EDA

The SFDA announces the update of the manual of regulations and requirements for the listing of cosmetic products through GHAD Portal.

Important Update from the Egyptian Drug Authority! EDA has issued a notification regarding the procedures for local manufacturers to import samples of medical supplies, laboratory devices, and fully manufactured diagnostic reagents for non-commercial purposes. Check out the official announcement: https://lnkd.in/dnSjRGeU You can also find the following document for further information: https://lnkd.in/dytkKpgf #MRG #EgyptianDrugAuthority #EDA #MedicalSupplies #LocalManufacturers