Regulatory updates for medical device manufacturers

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April 2014
Draft FDA Report Proposes US Health Technology Framework
High CMDR Compliance Rates for Medical Device Establishment License Holders in Canada
September 2014 Compliance Deadline for Indian Medical Device Labeling Rules
Reminder: July 2014 Compliance Deadline for RoHS 2
New Law in Brazil Changes Enforcement of BGMP Requirements for Certain Medical Devices
Japanese Regulators Plan Faster Medical Device Registration Process
FDA Report: US Medical Device Recalls Up nearly 100% since 2003
MDMA Compliance Looming for Saudi Arabian Medical Device Market
Training for Costa Rican Digital Medical Device Registration Pathway Announced
In Brief: New Blue Guide from European Regulators

March 2014
Chinese Medical Device Revisions Nearing Implementation
US FDA Updates Guidance on Feedback Mechanisms for Medical Device Registrants
US FDA Updates Electronic System for Medical Device Exporters
Staff Changes at Indian Regulator Could Boost Review Processes in the Long Term
Korean Regulators Waive Registration Requirements for Some Mobile Medical Devices
FDA No Longer Notarizing CDRH Export Certificates
US FDA Considering New Requirements for Off-Label Use Data

February 2014
New Saudi Arabia Declaration of Conformity Requirements Effective March 2014
New Educational Material from US FDA on Unique Device Identification System
Latest Guidance from US FDA: Computational Modeling, Devices using Animal Sources
Clarified Reclassification Rules from TGA for Implantable Devices
Analysis of 24,000+ FDA 510(k) records reveals trends
China Announces Expedited Market Authorization for Innovative Medical Devices
November Enforcement Date for New Pharmaceutical Affairs Law in Japan
US Medical Device Regulator to Improve PMA, IDE Processes
US Lawmakers Seek Regulatory Exemptions for Some Mobile Medical Devices and Apps

January 2014
US Medical Device Tax One Step Closer to Repeal
US FDA Provides 510(k) Communication Timeline
Chinese Regulators to Launch Simplified Registration Renewal Process in 2014
Colombian Regulators Set August 2014 Deadline for Medical Device Registrations
IMDRF Targets Uniform Standards for Medical Device Auditors
New INMETRO, IEC 60601 Requirements in Brazil
New Custom Device Exemption Guidance from US FDA
Peruvian Regulators Update Rules for Importing Unregistered Medical Devices

December 2013
Medical Device Regulatory Reform Advances in Japan
New Spanish Documentation Requirements for Argentina
Update on US FDA Unique Device Identification Submission System
Health Canada to Make Medical Device Clinical Trial Data Publicly Available

November 2013
Ukraine Plans Overhaul of Medical Device Regulatory System
Further Signs that ANVISA May Ease Brazilian GMP Requirements
Update on ANZTPA Medical Device Regulatory Harmonization in Australia and New Zealand
US FDA Shares More Details on MDSAP International Audit Pilot
Health Canada: MDSAP Pilot to Last Three Years
New Technical Director Requirements for Some Medical Devices in Argentina
Changes to Health Canada’s List of Recognized Standards

October 2013
EU Parliament Votes Focus on Tighter Rules for Medical Device Notified Bodies
Single QMS Audit Program Pilot for Medical Devices Set for January 2014
Top 5 Device Manufacturers Face Market Uncertainties in the US and Europe
Chinese Regulators Considering New Clinical Trial, Adverse Event Reporting Requirements
UK Regulators Requiring Public Registration of Medical Device Clinical Investigations
All Class I Devices Now Exempt from Korea GMP Requirements
US Government Shutdown to Impact FDA Medical Device Registrations
Health Canada Switching to Electronic Delivery of Medical Device Licenses
New FDA IDE Guidance for Early Feasibility Studies

September 2013
Final US Guidance on Medical Apps Limits FDA Oversight
Examples of Medical Apps that Fall under FDA Regulation (and Those that Don’t)
"Unofficial" NB Inspection Requirements Published by European Commission
New FDA UDI Requirements to be Phased in over Seven Years
Australian Regulator Issues Guidance on Mobile Medical Apps
Regulators Publish List of Medical Devices Exempt from Regulation in Peru
Possible Thaw in Russian Medical Device Regulatory Drama?
Brazil’s ANVISA Unveils Ambitious Overhaul Plans for Device Regulations
US Regulators to Notify Medical Device Industry of Premarket Data Changes
Russian Regulators Plan New Guidelines for IVDs
Digital Registration in the Works for Costa Rican Medical Device Market
New EU Animal Tissue Regulations in Effect for Some Medical Devices

August 2013
US FDA Extends Deadline for Conformity to New IEC Electrical Standard
New Device Maintenance Fee Schedule Announced in Argentina
New US Guidance on Good Laboratory Practice Compliance for 510(k) and PMA Submissions
Report Forecasts Seven-Percent CAGR for Global IVD Market through 2017
Proposed US FDA Small Business User Fees for 2014 Published
INVIMA Expands List of Medical Devices Requiring Registration in Colombia
Colombian Regulators Simplify Translation, Grouping Rules for Medical Device Registration
Meta Monitoring: Medical Device Firms’ Online Strategies under FDA Microscope
US FDA Plans Tech Improvements for IDE Submissions

July 2013
South Korea Revises Medical Device Regulations
MEDCAST online system for medical device registration in Malaysia
Australian Regulators Launch Adverse Event Database
IMDRF Proposes Convergence on Stand-Alone Software Regulation
Medical Device Spending not a Major Factor in Canadian Healthcare Costs
Russian Regulators Push Back Deadline for Medical Device Registration Reauthorizations
New Laws for Medical Device Registration Imminent in Argentina
ANVISA Sets Performance Targets for Next 12 Months
EU Membership for Croatia to Change Medical Device Registration Rules...Eventually

June 2013
Eucomed Guidance Clarifies RoHS Compliance for Medical Device Companies
US FDA Recommends Medical Device Cybersecurity Measures
CE Marking Certificates for Medical Devices Decreased in 2012
New Rules for Supplementary Information Requests in China
Rising Healthcare Costs not Directly Tied to Medical Technology, according to Study
ANVISA Plans Trial Period for 3rd Party B-GMP Audits
FDA Enforcement Letter: Preview of US mHealth Regulations?
Middle East Hospital Building Spree Means Boost in Future Demand for Medical Devices
Medical Device Sector in Taiwan Primed for Seven-Percent Growth

May 2013
US FDA Updates Plans for UDI and Post-Market Surveillance System
New IMDRF Guidance on UDI for Medical Devices
Recommendations for European UDI System Released
EU Parliament Publishes Response to Draft Regulations for Medical Devices
FDA issuing more warning letters, 47% increase inspections since 2008
US FDA to Require Proof of IEC 60601-1 3rd Edition in Summer 2013
Chinese Regulators Take Steps to Ease Medical Device Registration
Australian Regulators Propose Changes to IVD Oversight Plan

April 2013
Brazil GMP Requirements Streamlined
US FDA Guidance Explains User Fees for Medical Device Reviews
Health Canada: Export Equals Sale of Medical Devices

March 2013
Brazilian Regulator Considers Accepting Foreign GMP Certifications
FDA Mobile Medical App Regulation Will Not Extend to Smartphones
Device Developers Should Take Note of Recent Changes to US Patent Law
Head of Russia's Roszdravnadzor Retires
Changes to Medical Device Registration in Egypt Announced
UK Regulator Opens New "Office" for Innovative Medical Devices

February 2013
Medical device excise tax in effect in the US
Revised clinical study requirements planned by US FDA
Changes to INMETRO certification process in Brazil
Longer review times for licenses at Health Canada, according to trade group
Modifications to Argentina’s medical device law
New US Medical Device Tax on Manufacturers and Importers
US FDA to Accept Electronic Requests for Export Certificates

January 2013
Japanese Regulators Relax Medical Device Stability Testing Requirements
New Malaysian Medical Device Market Regulations Published
South Korea Regulators Scale Back KGMP Inspection Requirements
Federal Reimbursement System for Telemedicine Proposed in US
Mexico Readies GMP, Technovigilance Requirements for Medical Devices
US FDA Publishes Revised List of Recognized Medical Device Standards
Reminder: January 31 US FDA Establishment Registration Renewal Deadline Approaching
New "Refuse to Accept" policy now in force for US 510(k) applications
Details of Russian Medical Device Regulatory Changes Emerge
New European Electronic Labeling Rules for Medical Devices Coming
New Law in France Targets Medical Device Advertising

December 2012
Australia, Brazil, Canada and US Plan Shared Medical Device Audit Program
US FDA Establishment Registration Renewal Deadline Extended
FDA Report Claims Improved 510(k), PMA Review Times
New FDA Guidance on Home Use Medical Devices

November 2012
Malaysia’s Voluntary System Closes Ahead of Mandatory Device Registration
Indian Regulators Issue New Registration, Licensing Guidance for Devices
Pakistan to Establish Regulatory System for Medical Devices
Chinese Regulators Pursue Heavier Penalties for Medical Device Violations
New AHWP Harmonization Goals Set for Asian Medical Device Markets
New Chinese Medical Device Labeling Requirements Set for 2013

October 2012
US FDA sets new 510(k) review timeframe and performance goals for 2013
Post-market surveillance of medical devices expanding in Argentina
Electronic filing requirements for FDA registration submissions on the way
Security plan for wireless medical devices needed from US regulators
Proposed changes to Europe’s device regulations could have big impact on manufacturers and their partners

September 2012
ANVISA, Brazil’s medical device market regulator, has ended a months-long strike
New European Norm Harmonized Standards Go Into Effect

August 2012
Important changes to US FDA establishment registration requirements
Harmonized Standards in the EU Changing, Updating

July 2012
China Regulatory Updates

June 2012
Regulatory Updates for Australia as a result of the RegTech Forum
EU PIP Scandal - Will PMA System Be The Result?

May 2012
Regulatory Updates for Europe: OJEC, Borderline Products, and PIP Scandal
Reforms taking place in the regulation of medical devices in Australia

April 2012
EU Labeling, Vigilance and EN 60601-1 News

March 2012
Important New MEDDEVs - 7 new Guidance Documents

January 2012
New and Revised European MEDDEVs

December 2011
CMC Decision on Labeling, Croatia, Translation Resource

November 2011
Australia: License Cancellation for Non-Payment of Fees, ARTG Database

October 2011
European Regulatory Update: RAPS, EU “Recast”
New/Updated Standards Published to the OJEC

August 2011
European Regulatory Update: RoHS Recast, CMC Decision on Labeling, New EU Commission Website
Major changes recommended to FDA 510(k) process

July 2011
Australia Regulatory Update
Brazil Relaxes BGMP for manufacturers with INMETRO certificate

June 2011
European Regulatory Update - Updated List of Harmonized Standards

May 2011
Brazil GMP Inspection Fees

April 2011
Regulatory Updates affecting the EU Market

March 2011
Expediting Customs Clearance with AofC Codes
Important US FDA Import Recommendations
Global Harmonization Task Force (GHTF) to Reorganize
Australian TGA Responses on Proposed Medical Device Regulation Reforms

February 2011
Evolving IVD Regulations in Europe
Australia TGA Clarification on IVD Audits

January 2011
European Union Regulatory Update
FDA Unveils Elements of Proposed Changes to 510(k) Process

December 2010
MEDDEV 2.7/4 and EU Court Ruling on E-Commerce
Regulatory Reforms in Mexico’s COFEPRIS

November 2010
EU Regulatory Updates - changes and pending revisions to regulatory guidance documents

October 2010
Changes to TGA Medical Device Applications

September 2010
Updates to medical device classification in Japan
Potential changes to registration process in Mexico

August 2010
Proposed Objectives for FDA CDRH's 510(k) program

July 2010
EU Regulatory Updates
US FDA 510(k) Regulatory Process Update

June 2010
Important 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
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
European Commission issues interpretation of Directive 2007/47/EC

April 2009
US FDA issues notice about Class III preamendment devices

February 2009
New European guidance documents on clinical data

January 2009
Italy registration deadline extended; recast of WEEE/RoHS; adverse event reporting possible changes

November 2008
EU Update: EN1041:2008

June 2008
Updated EN980:2008 standard for Medical Device Labeling released

May 2008
European borderline classification issue 1.1

March 2008
Proposed Changes to the GHTF Regulatory Auditing Guideline

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

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