FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices

FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices

On June 17, 2026, the US FDA finalized a new Class II classification for radiological machine learning-based quantitative imaging software. This episode breaks down the new rule, explaining how the inclusion of a Predetermined Change Control Plan (PCCP) creates a more streamlined process for future algorithm updates. We detail the specific device types affected and the special controls manufacturers must now implement, offering practical steps for regulatory and quality teams to adapt their strategies. Key Questions: - What is the new FDA classification for AI/ML imaging software announced on June 17, 2026? - How does a Predetermined Change Control Plan (PCCP) streamline post-market updates? - What specific device types fall under this new Class II regulation? - What are the "special controls" manufacturers must now implement? - How does this change affect the regulatory strategy for AI-based medical devices? - What steps should your QMS team take to prepare for a PCCP submission? - Are there specific labeling requirements under this new final order? - How can companies leverage this new pathway for faster market access? Sources: - https://www.federalregister.gov/documents/2026/06/17/2026-12166/medical-devices-radiology-devices-classification-of-the-radiological-machine-learning-based - https://www.fda.gov/about-fda/cdrh-new-news-and-updates/cdrh-new-news-and-updates How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex requirements like the FDA's new AI software classification. Our experts develop efficient regulatory strategies, create robust technical dossiers, and manage submissions to authorities worldwide. By combining local expertise with advanced AI tools, we streamline global market access, helping you get your products to patients faster. For support with your FDA submission, PCCP development, or global expansion, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and global device database at https://pureglobal.ai.

Brazil ANVISA SaMD Regulation Update: Preparing for Changes to RDC 657/2022

Brazil's health agency, ANVISA, has announced its 2026-2027 regulatory agenda, which includes a significant revision to the rules for Software as a Medical Device (SaMD), RDC 657/2022. This episode explores the reasons for the update, the potential changes manufacturers can expect regarding AI/ML validation and cybersecurity, and the practical steps regulatory affairs and quality teams should take now to prepare for the upcoming public consultations and new requirements. Key Questions: - What are ANVISA's key regulatory priorities for 2026-2027? - Why is Brazil planning to update its SaMD regulation, RDC 657/2022? - Which types of SaMD manufacturers will be most affected by these changes? - What new requirements related to AI/ML and cybersecurity can we expect in the revised rule? - How will the new rules likely align with international standards from the IMDRF? - When can companies expect public consultations on the draft regulation? - What practical steps should regulatory teams take now to prepare? - How can a proactive gap analysis help in preparing for the new ANVISA rules? Sources: - https://www.emergobyul.com/blog/2026/01/brazil-anvisa-announces-priorities-2026-2027-year - https://www.pure-global.com/post/anvisa-s-international-cooperation-and-regulatory-convergence-are-reshaping-brazil-s-medical-device-market - https://www.mattosfilho.com.br/en/unico/anvisa-approves-new-regulatory-framework-for-software-as-a-medical-device/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex market access challenges like ANVISA's upcoming SaMD regulation changes. Our local experts in Brazil can act as your official representative, develop a clear regulatory strategy, and use advanced AI to compile and manage your technical submissions efficiently. We monitor regulatory changes in real-time to ensure you are always prepared. Whether you are a startup or a multinational, we streamline your path to market in Brazil and over 30 other countries. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and regulatory database at https://pureglobal.ai to learn more.

Singapore HSA's 2026 Medical Device Grouping Guidance: Key Changes in GN-12-1-R3

Singapore's Health Sciences Authority (HSA) released its updated guidance on medical device grouping, GN-12-1-R3, on June 2, 2026. This episode provides a detailed analysis of the key changes, including stricter criteria for device families, new requirements for systems and procedure packs, and the direct impact on manufacturers' registration strategies, costs, and timelines in Singapore. We outline the mandatory effective dates and provide practical steps for regulatory teams to ensure compliance with the new rules. Key Questions: - What are the most significant changes in Singapore's new GN-12-1-R3 guidance? - How do the updated device family criteria affect our submission strategy? - Will our existing product groupings be accepted for future renewals? - What are the new rules for grouping systems and procedure packs in Singapore? - How will these changes impact registration costs and timelines? - When does this new HSA guidance become mandatory for submissions? - What immediate actions should our regulatory team take to adapt? - How does this guidance affect IVD manufacturers specifically? Sources: - https://www.hsa.gov.sg/medical-devices/guidance-documents How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech and IVD companies navigate complex market access challenges like Singapore's updated HSA requirements. Our local experts and advanced AI tools streamline the development of regulatory strategies and the compilation of technical dossiers, ensuring your submissions are compliant and efficient. By leveraging our global representation network, we act as your local partner to manage the entire registration process, helping you get to market faster. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI regulatory tools and global device database at https://pureglobal.ai.

Australia TGA UDI Deadline: Class III & IIb Device Compliance by July 1, 2026

Australia's Therapeutic Goods Administration (TGA) is enforcing its first major Unique Device Identification (UDI) deadline on July 1, 2026. This episode details the critical compliance steps for manufacturers and sponsors of Class III and Class IIb implantable medical devices. We cover the dual requirements for applying a UDI carrier to labels and submitting comprehensive device data to the Australian UDI Database (AusUDID). Learn the practical actions your team must take now to avoid market access disruptions for your high-risk devices. Key Questions: - What is the TGA's July 1, 2026 deadline for high-risk medical devices? - Which device classes are impacted by this first major UDI compliance date? - What are the dual requirements for UDI carriers and AusUDID data submission? - How does this deadline affect Australian sponsors and overseas manufacturers? - What happens if a device is not compliant by the deadline? - What specific data elements are required for the Australian UDI Database? - How should manufacturers and sponsors coordinate to ensure compliance? - What are the essential last-minute checks for your quality and regulatory teams? - What steps can you take now to prepare your UDI data for submission? Sources: - https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supplying-medical-devices/about-medical-devices - https://www.reedtech.com/tga-class-iii-iib-compliance-phased-rollout-2026/ How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, simplifying access to over 30 global markets. Our experts act as your local representative, develop efficient regulatory strategies, and use advanced AI to compile and manage technical dossiers for submission. We help you navigate complex requirements like Australia's UDI implementation, ensuring your products remain compliant from initial registration through post-market surveillance. With our global reach and local expertise, we streamline the process, helping you get to market faster. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI regulatory tools and global device database at https://pureglobal.ai.

Japan PMDA SaMD Guidance: Key Changes from the June 2026 Update

On June 5, 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its core guidance for Software as a Medical Device (SaMD). This episode breaks down the key changes, including new requirements for AI/ML validation, heightened cybersecurity expectations, and clarified classification rules. We explore how these updates will impact regulatory strategies, submission timelines, and what practical steps SaMD manufacturers should take to ensure compliance and successful market access in Japan. Key Questions: - What specific changes did the PMDA make to its SaMD guidance on June 5, 2026? - How do these updates affect the classification of software medical devices in Japan? - What are the new expectations for AI and machine learning (AI/ML) SaMD validation? - What does the updated guidance say about cybersecurity requirements for SaMD? - How will these changes impact submission timelines for the Japanese market? - Who is most affected by this PMDA update? - What practical steps should regulatory teams take right now to prepare? - How does this update fit into Japan's broader digital health strategy? Sources: - https://www.pmda.go.jp/english/whatsnew/2026.html - https://www.pmda.go.jp/english/review/outline/devices/0007.html How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using advanced AI to compile and manage technical dossiers for submission. Our services cover the entire product lifecycle, from market selection to post-market surveillance, ensuring your products remain compliant with evolving regulations like the PMDA's SaMD guidance. With a global reach and local expertise, we help startups, scaleups, and multinational enterprises navigate complex regulatory landscapes. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI tools and regulatory database at https://pureglobal.ai.