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  • 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...