Stay updated on global regulatory changes affecting the medical device industry. Subscribe to our email newsletter which is published a few times each month. You can unsubscribe at any time if you decide you no longer want to receive the newsletter. Available in Deutsch and Français.
View samples of recent email newsletters:
- May 2012 - Europe Regulatory Updates OJEC, Borderline Products, and PIP Scandal
- May 2012 - Australia Regulatory Updates Reforms, ANZTPA, TGA offers online incident reports
- April 2012 - Regulatory Updates from Emergo Group EU Labeling, Vigilance and EN 60601-1 News
- March 2012 - Important New MEDDEVs 7 new Guidance Documents
- January 2012 - New and Revised MEDDEVs for the European Union
- December 2011 - European Regulatory Update CMC Decision on Labeling, Croatia, Translation Resource
- November 2011 - Australia Regulatory Update License Cancellation for Non-Payment of Fees, ARTG Database
- October 2011 - European Regulatory Update: RAPS, EU “Recast” information from the Regulatory conference
- October 2011 - European Regulatory Update New/Updated Standards Published to the OJEC
- August 2011 - European Regulatory Update (RoHS Recast, CMC Decision on Labeling, New EU Commission Website)
- August 2011 - Major changes recommended to FDA 510(k) process
- July 2011 - Australia Regulatory Update
- July 2011 - Brazil Relaxes BGMP for manufacturers with INMETRO certificate
- June 2011 - European Regulatory Update
- May 2011 - Update on Brazil GMP Inspection Fees
- APRIL 2011 - EU Regulatory Updates
- MARCH 2011 - Expediting Customs Clearance with AofC Codes
- MARCH 2011 - US FDA Import Recommendations
- MARCH 2011 - Global Harmonization Task Force (GHTF) to Reorganize
- MARCH 2011 - Australian TGA Responses on Proposed Medical Device Regulation Reforms
- FEBRUARY 2011 - Evolving IVD Regulations
- JANUARY 2011 - EU Regulatory Updates
- JANUARY 2011 - FDA Unveils Elements of Proposed Changes to 510(k) Process
- DECEMBER 2010 - MEDDEV 2.7/4 for clinical investigations & EU court ruling on e-commerce
- DECEMBER 2010 - Regulatory Reforms in Mexico's COFEPRIS
- NOVEMBER 2010 - EU Regulatory Updates
- OCTOBER 2010 - Changes to TGA Medical Device Applications
- SEPTEMBER 2010 - Japan Streamline Approval Process for Some Class II Medical Devices
- SEPTEMBER 2010 - Proposed Changes to Regulatory Approval Process in Mexico
- 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
- JANUARY 2009 - EU UPDATES: Italy registration deadline extended
- NOVEMBER 2008 - EU Update: EN1041:2008
- 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