Early December 2024 regulatory news brings updates from Europe, US, Brazil, China, and Japan, including new FDA guidance on change controls for AI-enabled devices and an innovation-focused approach to clinical research regulations in Brazil.
On December 6, 2024, the MDCG released guidance document MDCG 2024-16, detailing a new Manufacturer Information Form for reporting interruptions or discontinuations in the supply of certain medical devices and in vitro diagnostic devices. This form aligns with Article 10a of Regulation (EU) 2024/1860, amending the MDR and IVDR frameworks, and is designed for manufacturers to report supply changes for individual devices or multiple models. An accompanying annex, MDCG 2024-16 – Annex 1, includes a Device Identification Table requiring details such as the UDI-DI or EUDAMED DI for each model. Article 10a will take effect on January 10, 2025, mandating compliance from manufacturers.
Learn more about EU Medical Device Registration.
In December 2024, the FDA published a 49-page guidance document, "Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for AI-Enabled Device Software Functions." This forward-looking guidance outlines strategies to ensure the safe and effective development of medical devices incorporating AI technologies. It aims to assist manufacturers in supporting iterative updates to AI-enabled device software functions (AI-DSFs) while maintaining safety and effectiveness. The document also provides detailed recommendations for including a PCCP in marketing submissions, fostering innovation that enhances patient care and supports healthcare providers.
Learn more about FDA US Medical Device Registration.
On November 27, 2024, ANVISA's Board of Directors approved a comprehensive update to Brazil's clinical research regulations, aiming to reduce bureaucratic barriers and foster innovation. The new rules enable faster initiation of clinical trials, allow continuous data submissions, and harmonize national practices with international standards. This modernization is expected to attract more investments, strengthen public health, and accelerate the development of new medicines in Brazil.
On November 22, 2024, ANVISA released Circular Letter 01/2024, providing detailed instructions for companies on the procedural requirements for submitting medical device notifications and registration petitions. The guidance emphasizes compliance with sworn translation requirements, legally valid signatures, and the appropriate level of electronic signatures for interactions with public entities. The initiative aims to reduce rejections due to regulatory non-compliance and has been shared with industry associations and stakeholders involved in medical device regularization.
Learn more about ANVISA Brazil Medical Device Registration.
The Medical Device Technical Review Centre under the National Medical Products Administration (NMPA) is seeking public input on two draft guidelines for medical device registration reviews: the "Registration Review Guidelines for Fluorescence Imaging Performance Evaluation of Active Medical Devices" and the "Registration Review Guidelines for Carbon Dioxide Laser Therapy Equipment."
Released on November 28, 2024, these drafts are part of the 2024 Medical Device Registration Review Guidelines Development Plan. Feedback must be submitted via email by December 22, 2024, following specified submission formats. These guidelines aim to refine regulatory standards for evaluating performance and safety, fostering innovation while ensuring compliance.
Learn more about China Medical Device Registration & Approval.
The Ministry of Health, Labour and Welfare, in collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA), has announced the FY2024 Seminar on Approval Review as part of the Collaborative Plan for Optimizing Medical Device Regulation and Review 2024.
This initiative includes an online seminar (November 27 – December 27, 2024) covering topics such as application procedures, QMS inspections, and post-marketing safety, and a case study session (December 20, 2024) focusing on clinical evaluation needs. The program is designed for medical device manufacturers, developers, and professionals engaged in regulatory and quality assurance activities. Participation is free, and registration is open through the PMDA platform.
Learn more about PMDA Japan Medical Device Registration.
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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.
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As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
