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  • Regulatory NewsRegulatory News

    China Joins IMDRF’s Safety Information Exchange Program

    China’s National Medical Products Administration (NMPA) has joined an International Medical Device Regulators Forum (IMDRF) program that allows for the rapid exchange of safety and adverse event data, according to reports from the IMDRF meeting in Russia last month. NMPA now joins regulators across Europe, Australia, Canada, Japan, Singapore and the US in the IMDRF National Competent Authority Report Exchange, according to a report from state media last month. The ...
  • Regulatory NewsRegulatory News

    IMDRF Offers New Guidance on Cybersecurity

    In its first guidance document to deal exclusively with the cybersecurity of medical devices, the International Medical Device Regulators Forum (IMDRF) this week released new general principles and best practices to facilitate better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US Food and Drug Administration (FDA) and Health Canada, includes both pre-market and post-market cyber...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Adopts Risk-Based Model for Fecal Microbiota Transplants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Adopts Risk-Based Model for Fecal Microbiota Transplants   Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.   The model...
  • Regulatory NewsRegulatory News

    EC Issues Additional Guidance on Device Vigilance System

    While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...
  • Regulatory NewsRegulatory News

    IMDRF Takes Another Stab at IVDs, MDSAP

    Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...
  • Regulatory NewsRegulatory News

    IMDRF Works to Speed Entry of Devices Across Multiple Countries

    The International Medical Device Regulators Forum (IMDRF) proposed updates on Wednesday to clinical evaluation documents in support of rapid market entry across multiple jurisdictions. The IMDRF’s medical devices clinical evidence working group (MDCE WG) re-issued consultations Wednesday to propose updates to three Global Harmonization Task Force (GHTF) documents from 2007 and 2010. The MDCE WG’s consultation documents seek to reflect the recently implemented and/or ...
  • Regulatory NewsRegulatory News

    CDRH Proposes New IMDRF Work Item on Standards

    Medical device industry delegates and global regulatory authorities are looking to further support their collaboration with standards development organizations (SDOs) through a newly proposed liaison program. Scott Colburn, director of the standards program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), pitched an International Medical Device Regulators Forum (IMDRF) new work item (NWI) during a workshop hosted by the IMDRF s...
  • Regulatory NewsRegulatory News

    IMDRF Explains How to Build Submissions Using its Table of Contents Structure

    The International Medical Device Regulators Forum (IMDRF) issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents (ToC) structure, including harmonized technical guidelines on the acceptable folder structure and file format(s) for ToC-based submissions. The final guide was posted on Wednesday after IMDRF convened in Moscow—Russian regulators are currently chairing IMDRF—for a three-day open stakeholders forum that kicked off...
  • Regulatory NewsRegulatory News

    Health Canada Outlines Plan to Adopt IMDRF Table of Contents

    Health Canada is seeking industry feedback on guidance that describes its plan to formally implement the Table of Contents (ToC) structure, established by the International Medical Device Regulators (IMDRF) for a harmonized approach to the format of medical device market authorization applications. The implementation guidance identifies how Health Canada will adopt ToC formats as part of its efforts to support the global convergence of documentation requirements for m...
  • Regulatory NewsRegulatory News

    Transition to ISO 13485:2016 Comes to an End

    The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization. Both the 2003 and the 2016 version of the global consensus standard—developed by the International Organization for Standardization (ISO—co-existed until Thu...
  • Regulatory NewsRegulatory News

    DITTA Pinpoints Cybersecurity Best Practices Amid IMDRF Work

    The industry group that set forth the new work item for a globally harmonized approach to medical device cybersecurity, which is currently under development, released a new white paper that provides an overview of best cybersecurity practices in medical technology manufacturing. The new white paper is intended to increase a manufacturer’s level of cybersecurity sophistication in manufacturing and engineering processes by following seven principles. These include segment...
  • Regulatory NewsRegulatory News

    TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices

    Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate new guidance to propose a regulatory framework for personalized devices, including 3D-printed devices. The 19-page SaMD document expands on guidance TGA posted last December. The 23-page proposed regulatory scheme for personalized medical devices comes after the agency launched a consultati...