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  • Regulatory NewsRegulatory News

    WHO Details Plan to Combat Antimicrobial Resistance Globally

    The World Health Organization (WHO) finalized a report on combating antimicrobial resistance (AMR), stressing the urgency to act. The final report—developed by the Interagency Coordination Group on Antimicrobial Resistance (IACG)—identifies 14 recommendations centered on the urgency and action needed for a global fight against AMR. “The challenges of antimicrobial resistance are complex and multifaceted, but they are not insurmountable,” WHO said, arguing the report’...
  • 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 ...
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    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
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    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 ...
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    COCIR Pushes to Harmonize Device Standards

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued a position paper on Tuesday to facilitate the harmonization of medical device standards. COCIR’s position paper set forth six recommendations on harmonizing device standards, citing an array of existing challenges such as the assessment process and the fixed publication schedule. Harmonized standards need revision to reflect changes to and increased regul...
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    EU MedTech Industry Signals Need for Harmonized Approach to Cybersecurity

    EU’s medical technology trade association on Wednesday issued new recommendations to ensure a harmonized approach on medical devices and digital health technology cybersecurity. The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) developed a set of seven recommendations to EU authorities to help guide a harmonization strategy for cybersecurity in line with security requirements set via new or forthcoming legislative...
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    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...
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    ICH Advances Revised Guideline on Elemental Impurities

    The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for Elemental Impurities, developed via the International Council for Harmonisation (ICH), reached the fourth out of five steps in ICH’s process of regulatory harmonization last week, moving toward implementation of the revised guideline. The guideline was first recommended for...
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    AdvaMed Responds to Senator’s Call to Advance Cybersecurity

    Responding to a letter from Sen. Mark Warner (D-VA) that called for a collaborative effort to advance cybersecurity in health care, medical device industry group AdvaMed sought to ease concerns about the impact of cyber attacks with updates on industry and regulators’ moves in line with its five principles. The industry trade association’s board of directors adopted the set of five medical device cybersecurity principles in 2017 to drive best practices across its member...
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    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...
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    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...