By Stewart Eisenhart, Emergo Group Effectiveness of ongoing efforts to address medical device cybersecurity risks will depend on whether stakeholders can properly balance security, safety and usability issues as well as understand end-user environments, according to speakers at a new US Food and Drug Administration workshop. Get the full story here at the Emergo Group’s […]
Emergo Group
FDA and NIH launch new clinical trial protocol writing tool
By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
FDA proposes Conformity Assessment pilot
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants’ compliance with voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
China regulators formalize procedures for medical device expert panel meetings
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Eurasian governments progress on unified device regulatory system
By Stewart Eisenhart, Emergo Group Regulators in five Eurasian countries report progress in efforts to establish a harmonized medical device market that would incorporate Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
European medical device and IVD regulations officially published
By Stewart Eisenhart, Emergo Group The European Commission has officially published the Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746 on May 5, 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive […]
Common audit problems: Publishing audit reports
By Stewart Eisenhart, Emergo Group In the final installment of Emergo’s blog series on medical device quality management system audit problems, we examine the audit report publication process and related challenges. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
China FDA clarifies device recall requirements
By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have made reporting forms necessary for recall management available online. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its employees.
Brazilian INMETRO certifications compliance deadline stays
By Stewart Eisenhart, Emergo Group Brazilian regulators are leaving in place the latest deadline of May 1, 2017 for new INMETRO certification requirements for some medical devices, despite extending this deadline twice in the past. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
New Brazilian sanitary licensing regulations for medical device companies
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has implemented new risk-based requirements for domestic companies to obtain sanitary licenses. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its employees.