FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032

FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032

The US FDA has announced a public meeting on July 22, 2026, to discuss the proposed recommendations for the sixth reauthorization of the Medical Device User Fee Amendments (MDUFA VI). This episode breaks down the MDUFA framework, explores the key proposed changes for fiscal years 2028-2032, and analyzes the impact on manufacturers. We cover potential changes to submission review timelines, new initiatives for digital health and AI/ML devices, and the expected adjustments to user fees, providing practical steps for regulatory teams to prepare. Key Questions: - What is MDUFA and why is its reauthorization critical for device manufacturers? - What are the key proposed changes for MDUFA VI covering fiscal years 2028-2032? - How might new performance goals impact 510(k) and PMA review timelines? - What new initiatives for digital health and AI/ML devices are being considered? - When is the public meeting and how can manufacturers provide input? - What are the potential financial implications of the proposed user fee structure? - How does MDUFA VI aim to enhance the pre-submission and post-market processes? - What practical steps should regulatory teams take now to prepare? Sources: - https://www.federalregister.gov/documents/2026/07/07/2026-14531/medical-device-user-fee-amendments-public-meeting-request-for-comments - https://www.fda.gov/news-events/cdrh-new-news-and-updates/july-7-2026-register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex regulatory landscapes like the MDUFA reauthorization. Our experts develop efficient market access strategies, manage technical dossier submissions, and provide continuous regulatory monitoring to ensure your products remain compliant. By combining local expertise in over 30 markets with advanced AI tools, we streamline the registration process, saving you time and resources. Whether you're a startup or a multinational, we can help you prepare for MDUFA VI and accelerate your global expansion. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting

On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy NOTIVISA platform. This episode details the critical changes, including the adoption of the International Medical Device Regulators Forum (IMDRF) adverse event coding, which aligns Brazil's technovigilance requirements with global standards. We discuss the implications for manufacturers and Brazil Registration Holders (BRHs) and provide practical steps for updating quality systems, training teams, and ensuring compliance with the new structured data requirements. Key Questions: - What is the new e-Notivisa system launched by Brazil's ANVISA? - When did the e-Notivisa system become mandatory for adverse event reporting? - How does e-Notivisa change technovigilance requirements in Brazil? - What are the key differences between e-Notivisa and the old NOTIVISA system? - How does the adoption of IMDRF adverse event codes impact manufacturers? - Why is this new system important for global regulatory harmonization? - What immediate actions should manufacturers and Brazil Registration Holders take? - How should quality and regulatory teams update their procedures for the new system? Sources: - https://www.emergobyul.com/news/brazil-anvisas-new-e-notivisa-system-major-shift-medical-device-vigilance How Pure Global can help: Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in Brazil and over 30 other markets, managing post-market surveillance and ensuring compliance with evolving regulations like ANVISA's e-Notivisa system. Our experts can help update your QMS, train your team on IMDRF coding, and manage all submissions to keep your products on the market. Leverage our local expertise and advanced AI tools to navigate complex regulatory landscapes efficiently. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

Brazil ANVISA Regulatory Reliance: IN 290/2024 Changes for Class III & IV Devices

Brazil's ANVISA has implemented a more flexible amendment process for its regulatory reliance pathway for high-risk medical devices under Normative Instruction 290/2024. Effective June 2026, this change allows ANVISA to issue questions and request revisions for Class III and IV device submissions based on approvals from Comparable Foreign Regulatory Authorities (AREEs), rather than issuing an outright rejection for minor issues. This episode details the new interactive process, who is affected, and the practical steps manufacturers should take to leverage this more efficient pathway to the Brazilian market. Key Questions: - What is Brazil's new regulatory reliance process under IN 290/2024? - How does this change affect Class III and IV medical device manufacturers? - Which foreign regulatory approvals are recognized by ANVISA for this pathway? - What was the old submission process, and why is the new one more efficient? - How can manufacturers avoid outright rejection of their reliance submissions? - What practical steps should regulatory teams take to adapt to this change? - When did this new, more flexible process become effective? - Does this change reduce the documentation requirements for ANVISA submissions? Sources: - https://www.emergobyul.com/news/regulatory-reliance-authorizations-brazils-revised-anvisa-process-june-2026 How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a combination of local expertise and advanced AI. Our team helps you navigate complex landscapes like Brazil's ANVISA requirements, from initial regulatory strategy and technical dossier preparation to post-market surveillance. We act as your local representative in over 30 markets, using a single, efficient process to unlock multiple regions. Leverage our free AI tools and extensive device database at https://pureglobal.ai to accelerate your research, or contact us at info@pureglobal.com and visit https://pureglobal.com to learn how we can get your product to market faster.

EU MDCG 2026-4: SSCP Upload to EUDAMED for Class III & Implantable Devices

This episode covers the EU's new MDCG 2026-4 guidance, which transfers the responsibility for uploading the Summary of Safety and Clinical Performance (SSCP) from Notified Bodies to manufacturers. We discuss the impact on manufacturers of Class III and implantable devices, the key deadline of February 2027 for uploading the SSCP to EUDAMED, and the practical steps regulatory and quality teams must take to ensure compliance with this significant procedural change. Key Questions: - What is the major change introduced by MDCG 2026-4? - Who is now responsible for uploading the Summary of Safety and Clinical Performance (SSCP) to EUDAMED? - Which device classes are affected by this new guidance? - What is the deadline for manufacturers to upload the SSCP for existing devices? - When will the new EUDAMED functionality for manufacturer uploads be available? - How should manufacturers coordinate with their Notified Bodies for the validated SSCP? - What internal procedures need to be updated to comply with this change? - Why is this shift in responsibility significant for regulatory teams? - What are the first steps your company should take to prepare for the February 2027 deadline? Sources: - https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping them navigate complex requirements like the EU MDR and new MDCG guidance. We act as a local representative, develop regulatory strategies, and use advanced AI to compile and manage technical dossiers for EUDAMED submissions. Our experts can help you update your quality management system and internal procedures to comply with the new SSCP upload requirements, ensuring a smooth transition and continued market access in the EU. For support, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

China NMPA Innovative Device Approvals Accelerate: Market Access in 2026

China's NMPA is rapidly approving innovative medical devices, creating a major opportunity for global manufacturers. A new report reveals that 40 innovative devices were approved in the first half of 2026, bringing the total to 431. With approval timelines now under six months, this episode breaks down the criteria for the innovative pathway, the benefits for manufacturers, and the practical steps your team must take to leverage this accelerated route to market. Key Questions: - What is driving the NMPA's accelerated approval of innovative medical devices? - How many innovative devices have been approved in China in 2026? - What are the specific criteria for a device to qualify for the NMPA's innovative pathway? - How has the approval timeline for these devices changed? - What benefits does the innovative device designation offer manufacturers? - What are the key steps to prepare a successful application for this pathway? - Why is local expertise critical for navigating the NMPA's process? - What should companies consider for post-market surveillance in China after an accelerated approval? - Does this trend signal a long-term shift in China's regulatory landscape? Sources: - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQF7XcFgYS4yQrTNm7uKVY2dDFkaF0iUROahZQjE8hKjdsgJsSWco6-OL3J35xUOPCK9gfgrnBYWggMWdjZSB-A6TQ5uEM7pQ8nOOPJScuzOAkRoIHSYQTARItSFzKM3mUT9nqRXaxhbuTvh7A== How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech and IVD companies access global markets faster. Our experts in China can guide you through the NMPA's innovative device pathway, from initial eligibility assessment to compiling technical dossiers and managing submissions. With our local representation services and advanced AI tools, we streamline the registration process, helping you achieve compliance and commercial success. For a strategic partner in your global expansion, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI-powered regulatory database and tools at https://pureglobal.ai.