IMDRF Publishes 2026 Playbook for Medical Device Regulatory Reliance Programs
IMDRF releases its 2026 Playbook for Medical Device Regulatory Reliance Programs, outlining work-sharing, recognition and abridged pathways.
TGA Updates PRAC Guidance: What Sponsors and Manufacturers Need to Know in 2026
The TGA updated its PRAC recall procedure in February 2026. Here’s what medical device and medicine manufacturers must know about compliance and market actions in Australia.
FDA Issues Updated Final Guidance on Cybersecurity in Medical Devices
FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.
FDA Draft Guidance Aligns QMS Requirements with ISO 13485: What It Means for Medical Device Manufacturers
The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.
Novas normas internacionais em desenvolvimento para o setor dos dispositivos médicos
A ISO e a IEC estão a desenvolver e atualizar várias normas internacionais que afetam diretamente o setor dos dispositivos médicos e IVD, incluindo temas como qualidade, cibersegurança e software médico. Estas normas, como a ISO 13485, ISO/IEC 82304-2 e IEC 81001-5-1, reforçam o compromisso global com a segurança, interoperabilidade e inovação responsável.