Regulatory updates affecting medical device and IVD manufacturers
Have an interest in international regulatory issues? Subscribe to our newsletter. Every email includes a one-click unsubscribe link if you decide you no longer want to receive it. Your name will never be sold or shared with anyone. Read our Privacy Policy .
See samples of past eJournal newsletters below:
- AUGUST 2010 - Proposed objectives for FDA CDRH's 510(k) program
- JULY 2010 - EU regulatory updates
- JULY 2010 - US FDA 510(k) regulatory process update
- JUNE 2010 - Regulatory changes in Australia
- APRIL 2010 - EU regulatory updates
- MARCH 2010 - Australia TGA updates IVD regulations
- FEBRUARY 2010 - Brazil ANVISA to require GMP starting May 22, 2010
- JANUARY 2010 - New version of European MEDDEV 2.7.1 on clinical evaluations released
- JANUARY 2010 - Update on 2007/47/EC and other recent EU regulatory changes
- DECEMBER 2009 - Update to European MEDDEV guidance document on EU vigilance
- NOVEMBER 2009 - Suggested Change to QSP 9.1-5, Advisory Notice, Recalls, and Vigilance Reporting
- OCTOBER 2009 - Notified Body sampling requirements for CE Technical Files
- JUNE 2009 - EU issues guidance on 2007/47/EC for companies selling in Europe
- APRIL 2009 - US FDA issues notice about Class III preamendment devices
- MARCH 2009 - New regulation for devices with an electrical component sold in Ontario, Canada
- FEBRUARY 2009 - New European guidance documents on clinical data
- SEPTEMBER 2008 - US FDA announces change to registration process
- JUNE 2008 - Updated EN980:2008 standard for Medical Device Labeling released
- MAY 2008 - European borderline classification issues
- MARCH 2008 - Proposed Changes to the GHTF Regulatory Auditing Guideline
- OCTOBER 2007 - FDA revises user fees for 2008-2012
- OCTOBER 2007 - Upcoming Changes to the European Medical Device Directive
- SEPTEMBER 2007 - Amendments to the European Medical Device Directives published.
- JUNE 2007 - EU issues guidance document on medical device post market surveillance and vigilance
- APRIL 2007 - Hip, knee and shoulder reclassification
- FEBRUARY 2007 - Bulgaria and Romania admission to the EU and impact for medical device manufacturers.
- JANUARY 2007 - EU releases new guidance document for e-labeling
