By Stewart Eisenhart, Emergo Group Mexican regulators are in the early stages of revising various elements of the country’s sanitary registration process for medical devices, including classification, biocompatibility and technovigilance. 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 […]
blog
Chinese FDA updates recall process for medical devices
By Stewart Eisenhart, Emergo Group Medical device regulators at the China Food and Drug Administration (CFDA) have issued a new provision on its recall process for defective devices. 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 […]
New Indian medical device regulations for 2017
By Stewart Eisenhart, Emergo Group The Indian government is planning a significant overhaul of its system for regulating medical devices and IVDs. Emergo is still analyzing the new Medical Device Rules 2017 to determine how the new regulations will affect registration requirements in India, but we can now report on some general points found in […]
Brazilian regulators drop medical device fees
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulators plan to officially reduce registration and quality inspection fees for medical device companies after the country’s Ministry of Finance attempted to push through a hefty increase of those fees in 2015. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Brazilian regulators add two firms to MDSAP medical device quality inspection program
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has added two more firms to its list of accredited inspectorsfor the Medical Device Single Audit Program (MDSAP). 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 […]
New medical device rules from Indian regulators
By Stewart Eisenhart, Emergo Group India’s Ministry of Health and Family Welfare has released long-awaited new medical device and in vitro diagnostic (IVD) regulations that take effect in January 2018. 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 […]
5 key takeaways from Emergo’s medical device industry outlook
By Stewart Eisenhart, Emergo Group Emergo’s latest survey of more than 3,000 medical device industry participants finds renewed focus among companies on US and European markets, as well as more bearish expectations for BRIC markets and greater challenges addressing regulatory compliance. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA offers Pre-RFD program for combination products
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has issued new draft guidance clarifying the agency’s Pre-Request for Designation (Pre-RFD) process whereby combination product manufacturers may request initial feedback regarding classification and regulatory oversight questions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Does your medical device and IVD sales need an import license in India?
By Stewart Eisenhart, Emergo Group India’s medical device registration system is still transitioning to a more formalized and predictable framework, which has raised questions from foreign manufacturers about what regulators do and do not currently require for market authorization in the country. In many cases, one requirement foreign firms can be sure of is the […]
