Russian deadline for replacing old medical device licenses extended

By Stewart Eisenhart, Emergo Group The Russian government has pushed back a deadline for replacing medical device registration licenses issued before 2013 to December 2021 in order to harmonize requirements under the Eurasian Economic Union Agreement. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

E.U. publishes final version of medical device regulations

Ronald Boumans, Emergo Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20. Following these votes, the MDR and IVDR are expected to be formally published in late

Medical device enforcement is getting more serious—particularly in Northeast

There has been aggressive momentum on the side of federal medical device anti-corruption enforcers, in particular in the Northeast. Maureen Ruane and Scott McBride, Lowenstein Sandler There are more questions than answers on what a new and unconventional administration in the White House will do in 2017 in many areas, no less so in medical

Medtech stories we missed: Feb. 17, 2017

Several companies released diabetes study results this week, while companies like BioTime closed on their public offerings and Pixium implanted its first bionic eye. Here are medtech stories we missed this week, but were still worth mentioning. 1. Insulet touts glucose control study Insulet Corp. announced the results from its first feasibility study of its Omnipod Horizon hybrid

Senate bill aims to streamline FDA inspections process

Brad Perriello, Executive Editor A bill filed this week in the U.S. Senate seeks to streamline FDA inspections of medical device manufacturers by creating a more transparent, risk-based approach applied consistently across the federal watchdog’s regional offices. Sponsored by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.), the bill would direct Health & Human Services Dept.

Chinese regulators modify IVD classification requirements

By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have issued a new order affecting how in vitro diagnostic (IVD) devices are classified according to risk levels. 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

Electric medical device regulatory standards have changed: Here’s how

Dirk Smith, Co-founder of Minnetronix Medical devices in 2016 continue to benefit from dramatic technology developments across engineering disciplines. Electronic-based devices, in particular, are increasingly employing cutting-edge technologies to meet user demands for fast, multi-function, usable, safe and cost-effective products. As complexity in devices and technology rapidly evolve, regulatory requirements are following suit, with significant

Mexico proposes changes to medical device regulations in 2018

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

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

Medtech stories we missed: Feb. 10, 2017

From Glytec partnering to beat diabetes to Biolase, Gramercy Extremity Orthopedics and more getting FDA clearances, here are 7 recent medtech stories we missed this week, but were still worth mentioning. 1. BioTime proposes public offering of common stock Clinical-stage biotechnology company BioTech is intending to offer common stock shares in an underwritten public offering. BioTime focuses

Senate confirms Price as HHS chief

The Senate confirmed Rep. Tom Price (R-Ga.) to head the Health & Humans Services Dept. in a 52-47 vote early this morning. No Democratic senator voted to support the new administration’s nominee, but he was passed through in the Republican-majority Senate. Democrats spent hours last night protesting his confirmation, pushing the vote until 2 A.M.

India plans spate of new medical device regulations in 2017

By Stewart Eisenhart, Emergo Group The government of India 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

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

MasterControl and Lorenz: Here’s how they’ve streamlined document management

MasterControl, a provider of enterprise quality management systems, and Lorenz Life Sciences Group, a regulatory information management solutions provider, have a decade of joint success when it comes to customers streamlining and integrating their document and submission management services. “Integrating with an industry leader, MasterControl, has been providing a seamless way for customers to drag-and-drop

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 inspectors for 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