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  • 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

    Brazilian Device Industry Prepares for eSubmissions

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting . The meeting provided an opportunity for the agency to discuss its implementation strategy for the International ...
  • Regulatory NewsRegulatory News

    IMDRF Moves Forward With Effort to Standardize Global Device Submissions

    The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada. Background IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture withou...
  • Feature ArticlesFeature Articles

    Medical Device Industry and Regulator Harmonization Efforts Update

    Introduction As more countries formalize medical device regulations, international regulatory and quality systems professionals must continually refine and harmonize their internal processes for registration of medical device products and adherence to international quality standards. Although premarket registration and quality systems are often the responsibility of separate departments, they are intertwined, and these departments should work closely together. A regulato...