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• The Dynamic Medical Technology Industry: An American Asset
• Protecting Patients and Limiting Risk: FDA and Manufacturers' Pro-Active Response
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• MDUFMA Overview: Preparing FDA for 21st Century Medical Technology
• Preparing FDA for 21st Century Medical Technology
• The Dynamic Medical Technology Industry: An American Asset
• What is Medical Technology?
• Medicare Modernization Act of 2003: Improving Patient Access to New Medical Technology
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• Health Information Technology: Improving Patient Safety and Quality of Care
• Determining the Safety of Medical Technologies: The FDA Pre-Market Approval Process
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Policy Positions
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• New Clinical Diagnostic Laboratory Tests: Flaws in Medicare's "Gap Fill" Payment Methodology Make it a Risky Approach for New IVDs
• Clarifying the Intent of Medicare’s “Exclusion” Law
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• Implementation of Section 942 of the Medicare Prescription Drug Improvement and Modernization Act: Reforming CMS Payment Processes for New Clinical Lab Tests
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Comments & Testimony
FDA & Regulatory
• AdvaMed’s Interventional Cardiology Working Group Plays Important Role in Drug-Eluting Stent Issues
• Industry's Input Included in Report from HHS Secretary's Advisory Committee on Genetics, Health and Society
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Premarket
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Science & Tech
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Medicare & Reimbursement
• CMS Releases Proposed Rule on the Inpatient Prospective Payment System
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• MEDPAC Posts Study On Creating An Evidence-Based Medicine Center
• MEDPAC Posts Study On Creating An Evidence-Based Medicine Center
• MedPAC Approves Recommendations on Hospital Payment Update, Reduced IME Payments
• CMS Releases Final 2008 Outpatient Payment/ASC Rule and Final 2008 Physician Fee Schedule Rule
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Fraud & Abuse
Medicare & Payment Alerts (M.A.P.)
• HHS Proposes Adoption of ICD-10 Code Sets and Updated Electronic Transaction Standards
• CMS on the M.A.P.
• CMS Releases FY 2009 Inpatient Hospital Payment Final Regulation
• CMS Announces Potential National Coverage Decision Topics
• CMS ANNOUNCES THREE APPOINTMENTS TO THE APC ADVISORY PANEL AND SOLICITS PPAC NOMINATIONS
• AdvaMed Releases Summary of Proposed '09 Hospital Outpatient Prospective Payment System & Ambulatory Surgical Center Rule
• CMS Releases Proposed 2009 Physician Fee Schedule Rule
• CMS Announces New Bundled Payment/Gainsharing Demonstration
• CMS Ad Campaign To Increase Traffic On Its Hospital Compare Website
• CMS Announces Prices for Competitive Acquisition Program For DMEPOS
• CMS Announces Dates ICD-9 Coordination and Maintenance Committee Meetings
• CMS Calls For Recommendations of Quality Measures For Physicians
• MedPAC Approves Recommendations on Hospital Payment Update, Reduced IME Payments
• AHRQ on the M.A.P.
• MEDPAC Posts Study On Creating An Evidence-Based Medicine Center
• MEDPAC Posts Study On Creating An Evidence-Based Medicine Center
• CMS Releases Notice Soliciting Nominations to the Advisory Panel on Ambulatory Payment Classification (APC)
• CMS Releases Notice Correcting Final HOPPS, ASC, and HIPPS Rules
• OIG Issues 2005 Orange Book Recommendations Mending Numerous Changes For HHS Operations
• Administration Releases FY 2008 Budget
• Senate Approves Leavitt As HHS Secretary
• HHS Report On Medical Innovation
• HHS Releases Report On Promoting Medical Innovation
• HHS on the M.A.P.
• GAO Releases Report on Class III Medical Devices
• OIG Releases 2007 Work Plan
• CMS and OIG Issue Safe Harbors
• HHS Advisory Committee Releases Report On Reimbursement of Genetic Tests and Services
• President Sends FY 2006 Budget to Congress
• Administration Releases FY 2007 Budget
• Office of Inspector General Issues Two Gainsharing Opinions
• CMS Announces Round Two Sites and Products Under DMEPOS Competitive Bidding Program
• CMS Releases Revisions to the Final Physician Fee Schedule Rule Delaying Implementation of Anti-Markup Provisions
• CMS Releases Report to Congress On Plan To Implement Hospital Value-Based Purchasing
• AdvaMed Files Comments On Proposed Outpatient Payment and ASC Rules
• CMS Releases Final 2008 Outpatient Payment/ASC Rule and Final 2008 Physician Fee Schedule Rule
• CMS Seeks Comments On Proposed Form To Be Used To Describe Scope And Nature Of Clinical Research Under The Clinical Research Policy
• CMS Announces Bidders Conference for the Medicare DMEPOS Competitive Bidding
• CMS Re-Opens Clinical Trial Policy and Issues Proposed Decision
• AdvaMed Files Final Comments on the Proposed 2008 Physician Fee Schedule Rule
• CMS Posts Application Information for FY 2009 IPPS New Technology Add-on Payments
• Medicare Proposes New Rules for ASCs that Serve Medicare Patients
• HHS/CMS Announces Joint Effort with the Department of Justice to Fight “Infusion Therapy Fraud” in South Florida
• CMS Releases Final Rule on FY 2008 Inpatient Prospective Payments
• CMS To Host An Open Door Forum Call On The Ambulatory Surgical Centers Rule
• ASC and HOPPS - Quick Draft Summaries and CMS Open Door Forum On These Regulations
• CMS Releases Proposed Outpatient Payment and ASC Rules and Final Rule On Revised Payment System Policies For Services Furnished in ASCs
• CMS Issues and Implements Final Medicare Clinical Research Policy
• CMS Issues Proposed Decision on Medicare Clinical Trial Policy
• DRA 5007 Gainsharing -- CMS Seeking Rural Applicants
• CMS Releases Proposed 2008 Physician Fee Schedule Rule
• AdvaMed Submits Comments On Proposed Clinical Research Policy
• CMS Posts Options Paper on Hospital Value-Based Purchasing
• Secretary Leavitt Reports Progress on Value-Driven Health Care Initiative
• Secretary Leavitt Reports Progress on Value-Driven Health Care Initiative
• CMS Releases Final Rule on DMEPOS Competitive Acquisition
• HIT on the M.A.P.
• CMS Releases Final Rule on DMEPOS Competitive Acquisition
• CMS Proposes Expanded Coverage of Angioplasty 02/01/07
• AdvaMed Submits Comments to CMS on Outpatient Issues
• CMS Releases Rule 12/12/05
• AdvaMed Submits Comments to CMS 08/09/05
• AdvaMed Sends Letter to CMS 02/21/06
• AdvaMed Files Comments on 2008 Rule 11/06/2006
• AdvaMed Submits Comments on Evaluation of LCDs for NCD Process
• Key Points from 2006 Rule 07/19/05
• AdvaMed Submits Comments to CMS 04/22/05
• AdvaMed Submits Comments on HCPCS Process
• CMS Posts Report to Congress and Application Forms for Clinical Lab Competitive Bidding Demo
• CMS Announces Medicare Hospital Gainsharing Demonstration
• AdvaMed Comments on AHRQ Handbook 11/29/06
• House Approves 2006 Budget Reconciliation Package
• HHS Announces Program 12/12/05
• CMS Holds ODF 04/19/05
• AdvaMed Submits Recommendations 09/01/05
• AdvaMed Makes Statement 07/24/06
• CMS Issues Interim Report on Specialty Hospitals
• CMS Grants AdvaMed’s Request to Release MEDPAR Data for the Entire 60-Day Comment Period for Both the Proposed and Final Inpatient PPS Rules
• 01/24/05 - CMS Receptive to AdvaMed Position and Recommendations
• CMS Issues 2006 Rule 04/26/05
• APC Panel Meets 02/25/05
• AdvaMed Makes Statements on Value-Based Purchasing 01/19/07
• AdvaMed Files Comments 10/10/06
• CMS Releases 2006 Rule 08/01/05
• AdvaMed Files Comments on the Proposed 2007 OPPS, ASC Update and FY 2008 IPPS Hospital Quality Data Rules
• CMS Issues DME Competitive Bidding Proposed Rule: Detailed Report
• AdvaMed Submits Comments to CMS 07/05/05
• CMS Releases Final Rule 11/03/05
• CMS APC Panel Meets
• HHS Solicits Comments on Regulatory Burden
• AdvaMed Submits Comments on Policy 08/11/06
• AdvaMed Submits Comments to CMS 04/04/05
• AdvaMed Provides CMS with Comments on Physician Payment Practice Expense Methodology
• AdvaMed Submits Comments to CMS 06/21/06
• CMS Holds New Technology Town Hall Meeting, 02/23/05
• MedPAC Meeting Part 1 04/22/05
• CMS Issues Report 05/10/06
• CMS Announces Approval of New Technology Intraocular Lens
• Payment Advisory Meeting 03/07/05
• AdvaMed Files Comments on CMS Rule 06/09/06
• AdvaMed Provides Comments to MCAC 03/30/05
• MedPAC Holds Meeting 12/08/05
• APC Groups Announced 07/07/05
• CMS Holds ODF 02/25/05
• CMS Announces Meetings Dates for PAOC Committee and APC Panel 01/04/05
• AdvaMed Submits Comments on Clinical Lab Competitive Bidding Demo
• Advamed Comments on Issues 03/16/05
• Jane Hyatt Thorpe to Join AdvaMed Staff 01/04/05
• AdvaMed Makes Statement at CMS Public Meeting on New Clinical Lab Test Payment
• CMS Issues Rule 04/26/06
• AdvaMed Submits Comments 04/25/06
• AdvaMed Provides Information on Rules 08/10/2006
• CMS Posts Report 04/25/06
• AdvaMed Submits Letter 11/28/05
• AMA Calls for Public Comments 08/08/06
• AdvaMed Submits Comments on Coverage 06/06/05
• CMS Announces ODF 04/27/05
• CMS Releases Revised Document 07/12/06
• AMA Calls for Public Comments 09/15/06
• CMS Releases Revised CED Guidance Document
• AdvaMed Makes Public Statement to CMS and PAOC on Competitive Bidding for DMEPOS Proposed Rule
• CMS Issues Guidance 04/07/05
• CMS Announces Town Hall Meeting 09/11/06
• MedPAC Discusses Analysis 03/11/05
• CMS Posts Fact Sheet 07/15/05
• AdvaMed Submits Comments on Coverage with Evidence Development Revised Guidance
• AdvaMed Submits Comments on Clinical Trials Policy Reconsideration
• AdvaMed Submits Comments on Demo 06/21/06
• AdvaMed Submits Letter on 2006 Rule 09/14/05
• CMS Releases Proposed Rule 04/13/06
• CMS Releases FY 2007 Rule 08/03/06
• AdvaMed Provides Information on Rules 08/10/06
• CMS Releases Proposed Rule for the Inpatient Prospective Payment System
• CMS Releases Payment and Fee Rules 11/06/2006
• AdvaMed Comments on OIG and CMS 12/12/05
• CMS Grants AdvaMed's Request 01/24/06
• AdvaMed Urges AHRQ to Research 03/17/06
• AdvaMed FILES Comment on CMS Proposed Inpatient Rule
• AdvaMed Files Comments on CMS Proposed Rule for Competitive Acquisition of DMEPOS
• AdvaMed Comments on Timing Issues 12/02/05
• AdvaMed Files Comments to CMS 07/07/06
• AdvaMed Submits Letter on Payment Adivory 10/06/05
• CMS Announces Open Door Meeting, 02/02/2005
• AdvaMed Provides Recommendations 03/15/05
• CMS ISSUES DME MAC RFP 04/18/05
• American Medical Association (AMA) Calls for Public Comments on Proposed Quality Measures for GERD, Geriatrics and Emergency Care
• Laboratory Diagnostics Bill Introduced in House
• CMS Releases Updates 05/02/05
• AdvaMed Submits Comments to CMS 10/27/05
• AdvaMed Files Comments on Schedules 09/30/05
• Administration Releases 2007 Budget 02/06/06
• CMS Announces Demonstration 09/15/06
• AdvaMed Submits Letter to CMS 08/24/05
• House Approves 2006 Budget 12/19/06
• Medicare Releases Statement 04/14/05
• CMS Announces ODF 04/01/05
• MedPAC Meetings 11/17/05
• AdvaMed Sends Letter of Support 09/13/05
• OIG Issues Advisory Opinion 11/17/06
• AdvaMed Submits Letter to CMS 04/07/06
• AdvaMed Submits Comments 10/06/06
• AMA Signs Agreement with Congress 02/22/06
• CMS Issues Final Inpatient Rule 08/02/05
• Quality Issues in CMS FY 2007 Rule 08/08/06
• AdvaMed Files Comments 07/07/06
• Congressional Budget Office Study 05/04/05
• AMA Signs Working Agreement with Key Congressional Committee Chairmen to Develop Quality Measures
• AdvaMed Sends Pre-NPRM Letter to CMS
• Medicare Hospital Payment Information Posted 06/01/06
• AdvaMed Submits Comments on Coverage 10/31/05
• AdvaMed Submits Comment Letter to CMS on DMEPOS Supplier Quality Standards
• AdvaMed Files Comments to CMS Proposed Collection Request
• AdvaMed Provides Additional Information on Proposed OPPS, ASC, and Physician Fee Schedule Rules
• MedPAC Meeting Part 2 04/22/05
• CMS APC Panel Meets
• AdvaMed Issues Comments to CMS on Rule 06/21/05
• APC Panel Meets 08/22/05
• Senate Finance Committee Introduces Legislation 05/12/05
• AdvaMed Submits Comments to CMS 06/08/05
• AdvaMed Makes Presentation to the Advisory Panel on Ambulatory Payment Classification Groups
• American Medical Association (AMA) Calls for Public Comments on Proposed Quality Measures for Stroke and Melanoma
• CMS Announces Approval of Lens 01/26/06
• CMS Issues Transmittals 11/28/06
• AdvaMed's Third Annual Conference, 02/22/05
• CMS Releases FY 2007 Final Inpatient Rule
• AdvaMed Submits Updated External Data Position Paper, 02/16/05
• Medicare Hospital Payment Information Posted on CMS Website Today
• Quality Issues in CMS FY 2007 Final Inpatient Rule
• AdvaMed Provides CMS with Comments 03/24/06
• AdvaMed Submits Comments on Evaluation 06/21/06
• Administration Releases FY 2007 Budget
• AdvaMed Makes Presentation to Advisory Panel 08/24/06
• AdvaMed Makes Statement to CMS 05/25/06
• CMS Holds ODF 03/11/05
• Citizens' Health Care Working Group Releases Report, Final Recommendations to Reform U.S. Health Care System
• MEDPAC Releases Comment Letter Supporting CMS Proposals
• CMS Extends Deadline 11/22/2006
• Summary of the Hospital Fair Competition Act of 2005
• CMS on the M.A.P. Archives
• President Directs Federal Agencies 08/23/06
• HHS Releases Agenda 05/20/05
• AdvaMed Files Comments on the Proposed 2007 Medicare Physician Fee Schedule Rule
• HHS Announces "Oncology Biomarker Qualification Initiative" and Posts FDA-CMS-NCI Memorandum of Understanding
• Medicare Demo 01/31/05
• 01/14/05: MedPAC Holds 2-Day January Mtg - Pt. 2
• Evidence Based Medicine 01/13/05
• CMS to Host Open Door Call to Discuss 2008 ASC Payment System Changes
• Open Door Participation Instructions
• CMS Posts Series of Decisions 04/05/05
• CMS Posts Ambulatory Surgery Centers Transparency Information
• President Sends FY 2006 Budget to Congress, 02/08/05
• President Bush Directs Federal Agencies to Increase Transparency of Health Care Program Quality and Costs
• CMS Hosts ODF 05/09/05
• MedPAC Issues Report 03/03/05
• CMS Implements MMA Category 01/03/05
• CMS Issues Documents 04/11/06
• CMS Holds Special Open Door Forum, 02/15/05
• CMS Announces Demonstration 09/06/06
• MEDPAC Assesses Hospital Payment Adequacy, Approves Recommendation for Payment Increase
• CBO Releases Report on Budget Options, 02/16/05
• CMS Announces Increase in Premiums 04/01/05
• CMS to Hold Special March 8th Open Door Forum on Specialty Hospitals
• GAO Releases Payment Report 12/01/06
• CMS Posts Information 08/21/06
• Kelly Statement for CTI Session
• CMS Issues FY 2007 Medicare Hospital Inpatient Proposed Rule
• CMS Issues Medicare Hospital Rule 04/12/06
• CMS Reconsiders Clinical Trials Coverage Policy
• HHS Submits Report to Congress
• AdvaMed Files Comments 10/09/06
• CMS Issues Final Decision on National Coverage for ICDs, 01/28/05
• CMS Reports Care Improves 11/14/05
• CMS Joins AHA to Offer Guidance 02/24/06
• MEDPAC Letter Applauds CMS for Proposed Changes to the Inpatient Prospective Payment System
• CMS Releases Results of Third Five-Year Review of Physician Work Values and Proposes Changes to the Practice Expense Methodology
• CMS Provides Additional Information 09/07/06
• CMS Posts Documents 03/09/05
• CMS Seeks Bids for Additional Medicare Administrative Contractors
• CMS Awards First of 15 Contracts to Process and Pay Medicare Claims
• New Work Group Chair 02/28/05
• CMS Re-Charters Advisory Committee 12/15/07
• CMS Estimates Phyiscian Fee Schedule Update to be Minus 4.6 Percent
• MedPAC Recommendations for Physicians & Imaging 01/13/05
• CMS Reconsiders Policy 07/11/06
• CMS Posts New Information 10/19/06
• CMS Seeks Bids 10/02/06
• AHRQ Announces Project 12/09/05
• CMS Announces HCPCS Public Meetings and Agendas
• MedPac Holds Two-Day January Meeting 01/13/05
• CMS Report Notes U.S. Health Care Spending Growth Slowed in 2003 01/11/05
• Sign Up for AdvaMed Medicare Policy Conference May 2-3, 2006 in Baltimore — Detailed Agenda Available On-Line!
• AHRQ Issues Draft Handbook 10/17/06
• CMS Announces Coverage Expansion 03/17/05
• CMS Announces Accreditation Organizations 11/27/06
• CMS Announces Open Door Forum 11/30/06
• AHRQ Releases Outline 02/09/06
• CMS Releases Results 06/22/06
• MEDPAC Finalizes Previous Policy Recommendations, Approves Recommendation for Inpatient and Outpatient Payment Increase
• GAO Report Expresses Concerns 08/02/05
• CMS Issues NCD 02/22/06
• GAO Releases Study 05/31/05
• CMS Announces Medicare Provider Feedback Town Hall Meeting
• MedPAC Releases Letter 06/12/06
• CMS Proposes Expanded Coverage of Angioplasty 02/01/07
• CMS Announces Rechartering and Plans 11/27/06
• CMS Issues Roadmap 07/27/05
• CMS Announces Contractors 01/06/06
• CMS Proposed Increased Payment 08/03/05
• HHS Announces Initiative 02/17/06
• CMS Releases 2006 Proposed Rule 07/18/05
• CMS Hires Ombudsman 03/23/05
• CMS Estimates Fee Update 04/10/06
• Lab Bill Intoduced in House 05/12/06
• CMS Issues Bidding Rule 04/24/06
• CMS Provides Additional Information on Demonstration to Support Physician-Hospital Collaborations
• Summary of Study
• MedPac Assesses Payment Adequacy 01/11/06
• Medicare Enters Agreement with National Oncologic PET Registry to Obtain Data in Connection with PET NCD
• AHRQ Listening Session Remarks 01/11/06
• CMS Issues Final Guidance Documents on Initiating NCD'S and External Technology Assessment Referrals
• CMS Holds New Technology Town Hall Meeting 2/23/05
• CMS Issues NCD on Bariatric Surgery Procedures
• MedPAC Finalizes Policy Recommendations 03/03/06
• CMS Joins With AHA to Offer HCPCS Coding Guidance
• CMS Holds Forum 02/23/06
• CMS to Host Open Door Call 08/29/06
• 1/21/05: CMS Expects Final ICD National Coverage Decision
• CMS Releases FY 2007 Final Inpatient Rule Wage Indexes and Payment Rates
• CMS Awards Contracts 08/01/06
• AHRQ Issues Handbook 10/17/06
• CMS Announces DMEPOS Medicare Administrative Contractors
• CMS and AHA Establish Clearinghouse 01/10/06
• CMS Publishes Rule 03/28/05
• CMS Releases Proposed Outpatient Payment, ASC, and Physician Fee Schedule Rules
• CMS Issues DME Competitive Bidding Proposed Rule
• CMS Releases Indexes and Rates 10/29/06
• CMS Announces Updated Call-In Information 01/18/07
• CMS Announces Final NCDs for PET Scans, 01/31/05
• CMS Announces Meetings and Agendas 03/29/06
• HHS Solicits Comments 01/09/06
• AHRQ LAUNCHES PROGRAM 09/30/05
• Frist, Clinton Introduce Technology 06/16/05
• CMS Announces First Meeting of the Advisory Panel For 2007 12/22/06
• MedPac Finalizes Policy 03/01/07
• MedPAC Considers Recommendations on Payments 12/07/06
• Dee Simons
• President Announces Request 01/28/05
• CMS Special Open Door Forum, May 9, 2005
• President Directs Federal Agencies to Increase Transparency 08/23/06
• Outline for Comments at ODF, May 9, 2005
• CMS Announces New Workshop 12/20/06
• MedPAC Preliminary Recommendations on Use of Comparative Clinical Info 01/13/05
• CMS Announces Demonstration to Support Physician-Hospital Collaborations to Improve Quality And Share Savings
• CMS to Hold Town Meeting 01/03/05
• CMS Posts Meeting Guidlines and Dates 03/28/05
• CMS Announces ICD Registry 10/28/05
• Medicare Enters Agreement 02/10/06
• CMS Releases Proposed Rules 08/08/06
• MedPAC Letter Applauds CMS 04/21/06
• Citizens' Health Care Group Releases Report 9/25/06
• CMS and AHA Establish Clearinghouse for HCPCS Coding Guidance
• CMS Releases Part I of Severity-Adjusted DRG Study
• CMS Releases Charge Compression Study
• Centers for Medicare and Medicaid Services (formerly HCFA) on the M.A.P.
International
• Chinese Embassy Requests Medical Equipment for Earthquake Relief
• AdvaMed Educates Chinese Reimbursement Officials about the Value of Technology
• Competitive Bidding
• Global Glossary
• Global Medical Technology Network
• Global Reimbursement
• Foreign Reference Pricing
• International Diagnosis Related Groups
• Position Papers
• Summary of WTO Ministerial Declaration
• DRG-Style Prospective Payment Systems
• Trade Issues
Asia
• AdvaMed, MITA Cosponsor Standards Workshop in China
• Major Notified Bodies
• China's Regulatory Environment for Medical Devices: 2005
• Key Contacts
• Key Contacts - ASIA
• Roundtable on Good Manufacturing Practice for Medical Devices
Japan
• Tokyo Office Contact Information
• Key Contacts, Japan
• ACCJ
Europe
• France Establishes New Committee for Cost Effectiveness Reviews
• Key European Websites
Latin America
• Argentine Regulations: Certificate of Origin
• Argentine Regulation: New Valuation Method for Imports
• Argentine Regulations: Safety Reguirements for Electrical Products
• Medical Technology Industry Comments on Anvisa's Proposal to Require Specific Economic Data
• Argentine Regulations: Certificate of Origin - Update
International News
• International News Alerts
• China's Anti-Monopoly Law Takes Effect August 1
• Call with US Senior Commercial Service Specialist in Mexico
• Brazil: Teleconference on Import Tariffs Alert
• Registration, Evaluation, Authorisation and Restriction of Chemical (REACH)
• Brazil: Possible Import Tariff Increases
• Italy Registration for Medical Devices
• New Requirements for Shipper's Export Declarations
• UK - Darzi Report Released
• US-EU Position MDD Recast
• June 30th FDA Audio Conference - Less Than Six Months Left to Comply with EU Chemical Regulations
• Israel: New Government-Industry Forum
• EC Consultation on Late Payments
• World Bank Procurement
• Relief Effort for China Earthquake
• Ukraine - Visiting Delegation to DC - Intellectual Property and Trade Secrets, May 12-16
• China International Equipment Fair (CMEF) to Meet in April 18-20 in Shenzhen
• World Health Organization: Continues Intellectual Property Work Plan
• World Health Organization (WHO) – Developments Affecting Medical Technology
• Swedish Medtech Event - February 19-22, 2008
• HHS Signs Agreement with China on Medical Device, Drug Safety
• SEC Disclosure of Trade with Terrorist Countries
• Chinese Government Annou