This week, we are reporting on medical device regulatory updates from Canada, Europe, Brazil, and China. China's NMPA released registration review timelines, clarification on MDR and IVDR vigilance terms is now available, and Health Canada updated validation rules for non-eCTD transactions.
Health Canada has released updated validation rules (Version 5.3) for regulatory transactions submitted in non-eCTD format, effective May 31, 2025. These rules aim to ensure valid electronic submissions, reduce errors, and streamline follow-ups with Sponsors. Sponsors are encouraged to use commercial validation tools prior to filing. Errors detected during validation will be detailed in a Validation Report sent to Sponsors via email. For more information, consult Health Canada's guidance documents or contact ereview@hc-sc.gc.ca.
Learn more about CDMR Canada Medical Device Registration & Approval.
The Directorate-General for Health and Food Safety has published an updated Q&A document (MDCG 2023-3 Rev.2) to clarify vigilance terms and concepts under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). Aimed at competent authorities, economic operators, and relevant stakeholders, the document promotes a harmonized understanding of vigilance requirements for medical devices and in vitro diagnostic devices. It aligns definitions with current regulatory standards and provides guidance for effective implementation. This non-exhaustive resource should be used alongside the Regulations and MDCG guidance documents.
Learn more about EU Medical Device Registration.
ANVISA has published Ordinance No. 1,644, listing normative acts in force as of November 30, 2024, aligning with its ongoing regulatory review process. The 2nd cycle resulted in a regulatory stock of 962 normative acts, a 2% increase since 2022, reflecting efforts to simplify and consolidate regulations. Key outcomes include the revocation of 256 regulations, 235 flagged for further review, and 127 categorized as "under review of merit." Full results are detailed in the 2023-2024 Cycle Results Report, accessible on ANVISA’s platform.
Learn more about ANVISA Brazil Medical Device Registration.
A report released on January 2, 2025, outlines the review times for registration submissions completed and transferred in November 2024. The analysis, measured in working days, provides details on average review times, expert consultation duration, and deficiency response periods. Class II and III product review times are calculated separately, excluding emergency reviews from the statistics. The data highlights NMPA’s efficiency in processing registration projects.
Learn more about China Medical Device Registration & Approval.
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The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
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.
