Egyptian Drug Authority’s Post

Training Course on Medical Devices Vigilance The #EgyptianDrugAuthority announces the opening of registration for Training Course on Medical Devices Vigilance. The training course aims to illustrate medical device safety, emphasize its importance in achieving medical device safety and effectiveness, and illustrate new medical device vigilance guidance and its requirements in pre-market and post-market phases and how to apply them. Training was also provided on the mechanisms for reporting various incidents or regulatory actions resulting from their use, as well as the importance of reporting and the basic information that must be available in each report, using the approved reporting forms according to the regulatory guidelines of the General Administration of Pharmacovigilance The training course is scheduled to be held on Tuesday, December 10 to 12, 2024, at EDA premises Maadi and/or online. The training course is targeting safety officers/ QPPVs of medical device companies. The training course will start at 9:30 AM and end at 2:30 PM. The last date to register is Sunday, December 8, 2024. Attendees will receive a certificate of attendance accredited by the Egyptian Drug Authority's Center for Continuing Professional Development. To register, please click on the following link: https://lnkd.in/dhyJcUTC #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

Uncovering the Gap in Medical Device Safety❗ Medical devices are indispensable tools in modern healthcare, yet their potential for adverse events cannot be overlooked. This research delves into the critical area of materiovigilance – the systematic monitoring of medical device-related adverse events. Find out more here ⬇️ https://lnkd.in/d-GkpbaA ✅ And Join us in our mission to enhance patient safety through our pharmacovigilance training course from zero to hero. For more details write your question and e-mail in the comments below ⬇️ #PVigilant_Health #be_vigilant_be_safe #pharmacovigilance #PVTraining #pharmacist #pharmacy #pharmacycareer #physician #Patientssafety #Drugsafety #egypt #unitedarabemirates #saudiarabia #dubai #medicaldevice

**Regulatory Affairs in Qatar: Simplified Guide for Medical Product Registration** Navigating regulatory requirements is a key step in bringing medical products to the market in Qatar. Here’s a simplified overview of the registration process: 1️⃣ **Understand the Guidelines** The Ministry of Public Health (MoPH) sets clear rules for medical product registration. Start by familiarizing yourself with the necessary requirements and submission timelines. 2️⃣ **Prepare Comprehensive Documentation** A complete and accurate dossier is essential. Ensure all technical, clinical, and quality data comply with MoPH standards. 3️⃣ **Collaborate with Trusted Partners** Work with authorized distributors and reliable suppliers to streamline the process. Their experience with the local market can make a big difference. 4️⃣ **Stay Updated on Controlled Substances** For psychotropic or controlled medicines (like tramadol), additional approvals and re-registration steps may apply. Be prepared to meet these specific regulations. 5️⃣ **Build Strong Communication** Maintaining positive relationships with stakeholders in the regulatory department ensures smoother coordination and quicker issue resolution. 💡 **Tip:** Regulatory compliance may seem complex, but with the right preparation and teamwork, the process becomes manageable. Focus on details, adhere to guidelines, and keep learning to stay ahead! #RegulatoryAffairs #QatarHealthcare #MedicalProductRegistration #PharmaLeadership #Compliance

You want to be licensed pharmacist in the UAE with (HAAD, DHA, and MOHAP) ? Pharmacy Licensing Exam Preparation – (GCC) course is your ticket to passing exam in the UAE. Don’t just dream about it, make it a reality with our expert course. for more information about the course click the link: https://lnkd.in/d4CaY2Z4 #PrometricExam #GCCPharmacists #PharmacyLicensing #PharmacyExamPrep #HealthcareRegulation #PharmacyCareers #PharmacyLicensingGCC #PharmaEducation #MiddleEastPharmacists #HealthcareOpportunities #PharmacyCertification #PharmacistsOfInstagram #GCC #MENA #UAE #PRAConsultancy

الهيئة العامة للغذاء والدواء (#SFDA) دورًا حيويًا في تنظيم والإشراف على الأجهزة الطبية في المملكة العربية السعودية. Saudi Food and Drug Authority (#SFDA) plays a critical role in the regulation and oversight of medical devices in #Saudi_Arabia. Regulation and Approval: SFDA evaluates and approves medical devices before they can be sold or used in the country. Manufacturers and distributors must register their devices with the SFDA, ensuring that they meet international and local standards. Market Surveillance: SFDA monitors medical devices in the market to ensure they remain compliant with safety and performance standards. This includes post-market surveillance, investigating adverse event reports, and conducting inspections. Quality Control: The SFDA ensures that medical devices adhere to strict quality standards, including assessing the manufacturing process, labeling, packaging, and instructions for use. Risk Management: SFDA plays a role in identifying and mitigating risks related to medical devices. This involves ensuring that devices do not pose undue risks to patients or users and enforcing recalls if necessary. Import and Distribution Control: The SFDA regulates the import and distribution of medical devices, ensuring that only authorized entities handle medical devices in Saudi Arabia. Training and Awareness: The SFDA provides training and guidance to manufacturers, healthcare professionals, and distributors about medical device regulations, proper usage, and safety protocols. The SFDA's regulations align with international standards such as those set by the International #Medical_Device Regulators Forum (#IMDRF) and the European Union Medical Device Regulation (#EU MDR). #Bioengineering #MedTech #Biotech #BME #MedicalDevices #HealthcareInnovation #Biomechanics #BioMed #MedicalTechnology #BioengineeringResearch #RegenerativeMedicine #Biomaterials #BiomedicalScience #HealthTech #HealthTech #MedicalInnovation #TissueEngineering #BiomedicalResearch #MedicalImaging #WearableTech

I am excited to announce that I have successfully completed the "Medical Device Regulation 2017/745 European Union Regulatory Affairs" certification course on Udemy.🎉📑 This program gave me a deep understanding of the regulatory landscape for medical devices within the EU. Below are the key areas covered during the course: 🎯Key Learnings: ✔Medical Device Regulation (MDR) 2017/745: Comprehensive overview of the regulation and its implementation. ✔Economic Operators: Roles and responsibilities within the medical device supply chain. ✔EUDAMED: Insight into the European database on medical devices and its importance. ✔UDI Identification and Registration: Understanding the Unique Device Identification system and how it aids in device traceability. ✔Risk-based Classification of Medical Devices: Detailed study of classifications for Class Is, Im, Ir, IIa, IIb, and III devices. ✔Conformity Assessment Pathways: Steps and requirements for conformity assessment based on device classification. ✔General Safety and Performance Requirements (GSPR): Core requirements for ensuring safety and performance. ✔Clinical Evaluation & Post-Market Clinical Follow-Up (PMCF): Processes for demonstrating device safety and effectiveness. ✔Post-Market Surveillance (PMS) & Periodic Safety Update Report (PSUR): Monitoring and reporting requirements post-market launch. ✔Post-market Vigilance: Processes to handle device safety issues post-launch. ✔Role of Competent Authorities & European Commission: Their roles within market surveillance and regulatory enforcement. ✔Medical Device Coordination Group (MDCG) Guidelines: Guidelines from MDCG on medical device regulations. ✔Brexit, Switzerland Mutual Recognition Agreement, Turkey, EFTA Agreement: Regulatory impacts of geopolitical changes on market access. I would like to extend my gratitude to #MartinConnely for his valuable instruction and guidance throughout the course.🙌 #MedicalDevices #EURegulation #MDR #RegulatoryAffairs #Compliance #MedTech #UDI #EUDAMED #RiskManagement #ClinicalEvaluation #PMCF #PMS #PSUR #MarketSurveillance #Vigilance #CompetentAuthorities #MDCG #Brexit #SwitzerlandMRA #TurkeyAgreement #Innovation #Certification

Navigating Class B Medical Device Registration in Singapore: Key Documents Required by HSA Are you planning to register a Class B medical device in Singapore? Before you can submit your registration to the Health Sciences Authority (HSA), it’s crucial to have all the required documentation ready. Missing documents can lead to delays or even rejection of your application. Here’s a checklist of the essential documents you’ll need: * Device Description and Intended Use: A clear and comprehensive description of the device, including its intended purpose. * Risk Classification Justification: Documentation that justifies why the device is classified as Class B based on HSA’s classification rules. * Quality Management System (QMS) Certificate: A valid ISO 13485 certificate for the manufacturer, demonstrating adherence to quality standards. * Essential Principles of Safety and Performance Checklist (EPSP): Evidence that the device meets the essential safety and performance requirements. * Declaration of Conformity (DoC): A signed declaration from the manufacturer confirming the device meets applicable regulatory standards. * Product Verification and Validation Reports: Clinical evaluation or performance studies supporting the device's safety and efficacy. * Biocompatibility, electrical safety, and sterilization validation reports, if applicable. * Labeling Information: Draft labels, Instructions for Use (IFU), and packaging artwork compliant with Singapore’s regulatory requirements. * Registration Status in Reference Countries: Proof of the device’s registration or marketing clearance in recognized reference countries, if applicable. * Post-Market Surveillance Plan: A plan outlining how the manufacturer will monitor the device’s safety and performance post-launch. * Device Registration Fee Payment: Evidence of payment of the relevant registration fees to HSA. At CoachToring.Com Regulatory Affairs, we specialize in regulatory affairs services to streamline the registration process and ensure compliance with HSA’s requirements. Let us guide you through the complexities of medical device registration, saving you time and effort. Connect with us to discuss how we can assist you in achieving a successful Class B medical device registration in Singapore! Contact: enquiry@coachtoring.com www.PharmacistCoaches.Com www.CoachToring.Com #RegulatoryAffairs #MedicalDeviceRegistration #ClassBDevices #HSA #CoachToring

The new legislation on Modular Manufacturing and Point of Care is now published under SI 2025/87.  The Medicines and Healthcare products Regulatory Agency held a webinar on Monday where they provided background and information on the changes. Throughout the presentation, I could not help draw the parallel with the operations that Cignpost Diagnostics had set-up for COVID testing and the challenges we faced in building an accredited QMS for a Hub and Spoke approach, with multiple sites (fixed, mobiles, homes) and time sensitive operations. The webinar covered some of the foreseeable GMP challenges such as: - Equipment and process qualification in the modular sites - Training of remote personnel - Decentralised DM MF (master file) update and annual submission - Management of sites added and removed from the operations - Local release process - QP oversight approach for consistent release - Self-inspection approach With the height of the Cignpost operation having over 60 remote sites, we had to deal with all of the above. There were very significant differences, such as the fact that QP oversight and release was not relevant, but we still had to have clinical oversight of test release. Similarly, we did not need a DM MF, however, we had to have robust processes to maintain our Quality Manual and general QMS documentation to reflect our operation at any point of time (location, type of test, devices types, etc.). Here are some other re-applicable learnings from a QA perspective: A centralised training approach for all lab personnel was one of the first key enablers of a compliant operation, ensuring that everyone spoke the same language and that every location had equivalent operations and used the same tools. One of the main challenges, due to the dynamic context, was the management of site additions and removals from the operation. This was eventually routinely managed once we implemented robust risk management and change management processes, and defined a facility qualification approach. One learning from that experience was that for a Hub and Spoke operation to work well, the digitalisation of processes is very important as communication is key and oversight is not possible without information from the operations. It also supported timely change implementation (e.g. SOP update). Also, for a Hub and Spoke operation with fast moving sites (location changes or on/off operations), then the organisation structure must include a robust technical team who can support qualification, governance, and internal audits. We were very fortunate to be working with regulators (the UKAS) who were open to innovative approaches and very supportive of our operating model. The management of MM and POC will have its own challenges of course and the MHRA is emphasising that they want a dialogue on the subject. They are looking at stakeholders to engage with them as they are working on additional guidance to implement the new legislation. 

#medical_device_company_international_standards #معايير_دولية_لاعتماد_شركات_الأجهزة_الطبية ISO 13485 Certification Purpose: An international standard for quality management in medical device manufacturing Issuing Body: International Organization for Standardization (ISO) Importance Ensures the company has a quality management system compliant with regulatory requirements for medical devices CE Marking Certification Purpose: European conformity marking required to market medical devices in the European market Issuing Body: European Union (EU) Importance Demonstrates that the medical device meets the safety and quality requirements of EU directives FDA Approval Purpose: Approval from the U.S. Food and Drug Administration (FDA) to market medical devices in the United States Issuing Body: FDA Importance: Required for entering the U.S. market Includes classification categories (Class I, II, III) based on the associated risk of the device ISO 9001 Certification Purpose: General quality management standard to improve processes and management Issuing Body: International Organization for Standardization (ISO) Importance Supports ISO 13485 certification and enhances administrative process efficiency GMP (Good Manufacturing Practices) Certification Purpose: Documentation of good manufacturing practices to ensure product quality and safety Issuing Body: Varies by country, such as FDA or local regulatory authorities Importance Confirms the company’s adherence to precise manufacturing standards IEC 60601 Certification Purpose: Safety standard for medical electrical equipment Issuing Body: International Electrotechnical Commission (IEC) Importance Ensures the safety and efficiency of medical electrical devices UL Certification Purpose: Tests and certifies electrical safety for medical devices Issuing Body: Underwriters Laboratories (UL) Importance Required for U.S. and Canadian markets RoHS Compliance Certification Purpose: Compliance with the restriction of hazardous substances in electrical and electronic equipment Issuing Body: European Union Importance Ensures that medical devices are free from harmful substances such as lead and mercury ISO 14971 Certification Purpose: Risk management for medical devices Issuing Body: International Organization for Standardization (ISO) Importance Ensures the evaluation and management of risks associated with the use of medical devices Medical Device Registration with Local Authorities Issuing Body Ministry of Health or local regulatory authorities in the target country Importance of Obtaining Certifications Market Expansion: Opens doors to local and global markets Quality Assurance: Builds a strong reputation for the company’s commitment to quality Regulatory Compliance: Ensures adherence to regulations in target countries Customer Trust: Increases the confidence of hospitals and patients in medical products #Biomedicalengineering #HealthcareTechnology

🌟 Proud to Announce: Completed 2017/745 Medical Device Regulation Training! 🌟 I am excited to share that I have successfully completed the 2017/745 Medical Device Regulation (MDR) Training and received my certification! This comprehensive training provided an in-depth understanding of the MDR framework, specifically focusing on Technical Documentation and Clinical Evaluation requirements. This certification marks a significant milestone in my career as a Regulatory Affairs Specialist, equipping me with: ✅ Expertise in 2017/745 MDR Compliance: Enhanced my ability to navigate and implement MDR requirements, ensuring medical devices meet stringent regulatory standards. ✅ Advanced Knowledge in Technical Documentation: Strengthened my capacity to develop, review, and maintain detailed technical files that are critical for device approvals. ✅ Proficiency in Clinical Evaluation: Gained insights into preparing robust clinical evaluation reports, interpreting clinical data, and aligning with regulatory expectations for device safety and performance. 💼 Impact on My Career: This training has not only enriched my technical and regulatory knowledge but also empowered me to contribute more effectively to the development and approval of innovative medical devices. It positions me to better support organizations in achieving compliance while advancing patient safety and care. 🔗 I am thrilled to apply this expertise to future projects and collaborations, ensuring regulatory excellence in the ever-evolving medical device industry.