This week in medical device regulatory news: updated guidance on MDR requirements for legacy devices, China released new product guidelines, revised UK guidance on Conditional Marketing Authorizations, and more.
On October 14, 2024, the National Medical Products Administration (NMPA) released the 2023 revised "Registration Review Guidelines for Imaging Ultrasound Diagnostic Devices (Class III)." This update aims to improve regulatory compliance and streamline the management of ultrasound diagnostic equipment for manufacturers.
On October 17, 2024, the NMPA followed with the release of the 2024 revised "Guiding Principles for Registration and Review of Breast Implant Products." The new guidelines enhance regulatory standards to ensure the safety and quality of breast implant products. Both guidelines are now available for download.
Learn more about China Medical Device Registration & Approval.
The Medical Device Coordination Group (MDCG) has released an updated document (MDCG 2021-25 rev.1) regarding the application of Medical Device Regulation (MDR) requirements to "legacy devices" and those placed on the market before May 26, 2021. Following the amendments of Regulation (EU) 2023/607, the transitional period has been extended to December 31, 2027, or December 31, 2028, based on device risk classification. This document offers essential guidance on the applicability of MDR requirements and includes a table outlining which requirements apply to legacy devices.
Learn more about EU Medical Device Registration.
The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance regarding Conditional Marketing Authorisations (CMAs), exceptional circumstances Marketing Authorisations, and national scientific advice, with the latest revision published on October 18, 2024. This guidance outlines the criteria and application processes for CMAs, particularly for products addressing unmet medical needs, and details the exceptional circumstances under which marketing authorisations can be granted. The document also provides information on the national scientific advice service available to developers and marketing authorisation holders. For more details, refer to the full guidance on the MHRA website.
Learn more about MHRA UK Medical Device Registration & Approval.
On October 21, 2024, ANVISA announced the implementation of a new list of subject codes for primary petitions related to clinical trials involving experimental advanced therapy products (ATPs). This change is in line with the new Clinical Research Law (Law 14,874/2024) and aims to streamline the screening and analysis process for these trials. The updated subject codes will enhance the efficiency of document management within the Datavisa system and ensure compliance with a 90-day deadline for health analysis. The reform responds to the increasing volume of clinical trial petitions and emphasizes the agency's commitment to regulatory quality and participant safety.
Learn more about ANVISA Brazil Medical Device Registration.
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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.
