The fifth revision to the EU's guidance on Notified Body requirements under the MDR and IVDR has been released. Canada published new guidance on machine learning-enabled devices, findings from China's Medical Device Standards Management Annual Report, and more in this week's round-up of medical device regulatory news.
The Directorate-General for Health and Food Safety has released the updated MDCG 2019-6 Rev. 5 document, addressing frequently asked questions about the requirements for notified bodies under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This revision highlights essential organizational and general requirements, including the need for legal personality, impartiality in consulting, and restrictions on pre-application activities. Key issues such as consultancy, conflict of interest management, and staff bans are discussed, providing crucial guidance for conformity assessment bodies to ensure compliance with EU regulations. This document serves as a dynamic resource, with potential future updates based on ongoing assessments.
Learn more about EU Medical Device Registration.
Health Canada has published new guidance to support manufacturers in demonstrating the safety and effectiveness of machine learning-enabled medical devices (MLMDs). This document outlines regulatory expectations for Class II, III, and IV MLMDs, including requirements for pre-market applications and amendments. Key topics include transparency, risk management, clinical validation, and the use of predetermined change control plans (PCCPs) to address evolving ML models. With a risk-based approach, Health Canada provides flexible pathways for compliance while ensuring patient safety and device efficacy throughout the MLMD lifecycle.
Learn more about CDMR Canada Medical Device Registration & Approval.
The National Medical Products Administration (NMPA) has released the China Medical Device Standards Management Annual Report (2024), detailing progress in standardization, regulatory enhancements, and international cooperation. In 2024, China surpassed 2,000 medical device standards, shifting from a quantity-driven model to a quality-focused approach. The report highlights key achievements, including new standard projects, industry participation, alignment with international standards, and the role of standards in fostering innovation and safety. Read the full report for insights into the evolving landscape of medical device regulation and its impact on the healthcare sector.
Learn more about China Medical Device Registration & Approval.
The Thai Food and Drug Administration (Thai FDA) has introduced significant improvements to the amendment system for Non-IVD medical devices, effective January 15, 2025. These updates aim to streamline the change notification process, making it more efficient and user-friendly for manufacturers and importers. Below is a summary of the key changes:
Cancellation of a Topic in the Change Notification System
New Topics Added to the Change Notification System
For detailed information, refer to the official Thai FDA announcement: Thai FDA Change Notification System.
Learn more about TFDA Thailand Medical Device Registration.
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Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
Pure Global participated in IMDEC 2024 in Kuala Lumpur to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation.
