Nancy Singer for Sparta Systems
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Further signs that ANVISA may ease Brazilian GMP requirements
By Stewart Eisenhart, Emergo Group
ANVISA, Brazil’s medical device market regulator, has issued a new public consultation (link in Portuguese) proposing eased Brazilian Good Manufacturing Practice (BGMP) requirements for medical device manufacturers submitting their products for registration.
Update on ANZTPA medical device regulatory harmonization in Australia and New Zealand
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries’ long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
Boston Scientific wins CE Mark, FDA nod for Direxion microcatheter
Boston Scientific (NYSE:BSX) said its Direxion microcatheter notched regulatory wins in the U.S. and Europe for peripheral embolization.
TriReme Medical notches another Japanese win
California-based TriReme Medical announced this week that the company and its partner Century Medical received Japanese regulatory approval for the GliderXtreme PTA catheter, designed to treat blockages in the arteries.
FDA takes a responsive approach to mobile web
By: Chris Mulieri
Since January 1, over 30 million visitors have come to FDA’s website. We know that they come to FDA.gov to get reliable and up-to-date information on everything from food and drug recalls to medical product alerts to regulations and guidance for industry…and the list goes on.
Johnson & Johnson confirms $2.5B hip lawsuit settlement, consumers group wants more
SonoSite wins FDA OK for ‘world’s 1st’ ultrasound kiosk
SonoSite this month won 510(k) clearance from the FDA to market its X-Porte ultrasound kiosk in the U.S., and the device maker’s planning to start shipping the device immediately.
The Bothell, Wash.-based medical device company said called the kiosk is an "important milestone” in providing access to point-of-care ultrasound visualization. The kiosk uses SonoSite’s proprietary Extreme Definition Imaging, which reduces imaging clutter to provide a higher resolution picture.
Ukraine plans overhaul of medical device regulatory system
By Stewart Eisenhart, Emergo Group
Regulators in Ukraine will implement significant reforms to the country’s medical device registration system in early 2014 in order to better align market authorization requirements with those of the European Union, Emergo Group has learned.
The new system will utilize national conformity assessments similar to those used by EU regulators, and also introduces the following requirements for Ukrainian medical device registrations: