Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.
Mexico’s medical device market regulator COFEPRIS has slated efforts to improve its third-party review (TPR) process and reduce registration timeframes for 2016.
US medical device regulators have specified types of devices for which premarket application submissions should include human factors testing information, according to new Food and Drug Administration guidance.
The US Food and Drug Administration has begun accepting account requests from labelers of Class II medical devices for the Global Unique Device Identification Database (GUDID).
US regulators have extended GUDID access ahead of a September 2016 UDI compliance deadline for Class II medical devices.
The FDA advises that Class II device labelers collect and validate data before applying for GUDID accounts or submitting UDI records.
The European Database for Medical Devices, or Eudamed, contains data on medical devices that have been collected and entered by Competent Authorities and the European Commission and can only be accessed by these same parties.
Medical device regulators at the US Food and Drug Administration have published new guidance targeting how manufacturers of electronic interoperable devices design their products as well as what to include in premarket submissions to the agency.
Brazilian medical device market regulator ANVISA has named a second firm, TÜV SÜD America, as an accredit audit organization under the international Medical Device Single Audit Program (MDSAP).
The US Food and Drug Administration is recommending stronger post-market efforts to manage cybersecurity risks for some medical devices and software products.
Brazilian medical device market regulators have reduced timeframes in 2015 for responding to and processing submissions from registrants, according to an Emergo analysis of data from ANVISA.
A recent survey of European Notified Bodies (NBs) shows that these organizations issued fewer CE Mark certifications for medical devices between 2011 and 2014 than in 2010.
On December 4, 2015, Health Canada (HC) confirmed their transition plan for the Medical Device Single Audit Program (MDSAP).