This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.
The regulatory authority has introduced updated guidelines (link in Thai) for the Refer and Transfer processes in medical device licensing. These changes aim to enhance transparency and compliance while ensuring public safety. Below are the details of the processes, requirements, and restrictions.
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These guidelines provide a clear framework for managing brand name changes (Refer) and ownership transitions (Transfer) in the medical device sector. By setting strict requirements and prohibiting cases with safety concerns, the authority ensures regulatory compliance while prioritizing public health.
Manufacturers and stakeholders are encouraged to review the complete guidelines to facilitate smooth licensing transitions.
Learn more about TFDA Thailand Medical Device Registration.
The European Commission’s Directorate-General for Health and Food Safety has released an updated guidance document, MDCG 2023-3 rev.1, providing a comprehensive Q&A on vigilance terms and concepts under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Published on November 11, 2024, this document aims to ensure a unified understanding among competent authorities, economic operators, and other stakeholders for effective implementation of vigilance requirements. The guidance aligns terminology with current regulations and incorporates modifications from earlier Medical Devices Vigilance System guidelines. It applies broadly to medical devices, in vitro diagnostic devices, and accessories, ensuring harmonized compliance across the EU.
Learn more about EU Medical Device Registration.
The National Agency of Medicines and Medical Devices in Romania reminds economic operators involved in the import, distribution, installation, and maintenance of medical devices about compliance with OMS no. 566/2020. This regulation sets the framework for approval under Title XX of Law no. 95/2006 on healthcare reform. Operating approvals are valid for three years, provided no significant changes affect the original conditions. Operators must ensure timely renewal to avoid disruptions in their activities. The announcement emphasizes the need for adherence to these regulatory requirements for continued authorization.
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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.
