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Regulatory updates for medical device manufacturers

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