By Stewart Eisenhart, Emergo Group Saudi Arabia’s medical device regulator, the Saudi Food and Drug Authority (SFDA), plans to introduce changes to the application process for obtaining market authorization in the country. 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 […]
Emergo Group
Singapore changes medical device field safety notice requirements
By Stewart Eisenhart, Emergo Group Singapore’s medical device market regulator now requires registrants issuing field safety notices (FSNs) regarding their products to copy managers of affected local healthcare facilities. 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 […]
Russian technical file requirements for medical devices and IVDs clarified by regulators
By Stewart Eisenhart, Emergo Group The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
FDA launches Experimental Learning Program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration is rolling out a new program whereby regulatory staff learn about new and innovative medical device technologies from industry to enhance premarket reviews and other regulatory processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
New clinical guidelines for medical devices from Australian TGA
By Stewart Eisenhart, Emergo Group Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical evidence for medical device and IVD manufacturers. 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 […]
New medical device rules change India’s Authorized Agent role
By Stewart Eisenhart, Emergo Group The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 2017. 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 […]
Little or no audit preparation common device QMS problem
By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches. Get the full story here at the Emergo Group’s blog. The […]
Trump proposes higher FDA fees for drug, medical device FDA registrants
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Medical device firms have little understanding of European MDR, IVDR
By Stewart Eisenhart, Emergo Group Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
Malaysia plans to ratify ASEAN Medical Device Directive
By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. 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 […]