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ITA Trade Facilitation Activities and Review of Key Medical Device Markets. MDMA Webinar December 16, 2008 Vince Suneja and Richard Paddock Office of Health and Consumer Goods (OHCG) U.S. Department of Commerce 202-482-3360 Richard

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ITA Trade Facilitation Activities and Review of Key Medical Device Markets

MDMA Webinar

December 16, 2008

Vince Suneja and Richard Paddock

Office of Health and Consumer Goods (OHCG)

U.S. Department of Commerce



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Global Medical Device Market Growth Potential Device Markets

  • The global medical device market is projected to exceed $250 Billion by 2012

  • U.S., UK, Japan, Germany, France, and Italy 15% of population, 75% of medical device use

  • China, India, Indonesia, Brazil and Pakistan have about half of the world’s population but consume only about 5% of medical devices globally

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Global Medical Device Device MarketsMarket ($USB)

Source: Espicom Business Intelligence

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Global Medical Device Market— U.S. Position Device Markets

  • U.S. medical technology companies lead the world in medical device production

  • The U.S. is the world’s largest market for medical technologies ($85 Billion)

  • U.S. share of world medical device market has held at roughly 45-47% in recent years

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U.S. Medical Device Exports (2007) Device Markets

Latin America


All Others




Total U.S. Medical Device Exports:

$31.9 Billion



Asia, Except Japan 10.0%

European Union


Source: U.S. International Trade Commission

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Global Market Share by Country Device Markets


























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ITA’s Mission Device Markets

To create prosperity by strengthening the competitiveness of U.S. industry, promoting trade and investment, and ensuring fair trade and compliance with trade laws and agreements

ITA is designed to help all companies, but particularly small and medium-sized ones

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ITA’s Structure Device Markets

  • U.S. and Foreign Commercial Service (FCS)

  • Trade Promotion/Export Expansion

  • Market Access and Compliance (MAC)

  • Trade Compliance/Barriers/” Country Experts”

    • Manufacturing and Services (MAS)

  • Competitiveness/Industry Outreach/” Sector Experts”

    • Import Administration (IA)

  • Enforcing Trade Laws (AD/CVD)

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    International Trade Administration Device Markets



    Market Access

    & Compliance


    & Services



    Global Network of

    Trade Specialists






    U s and foreign commercial service l.jpg
    U.S. and Foreign Commercial Service Device Markets

    • USG’s primary trade promotion agency

    • Over 2,000 trade professionals worldwide based at 160 offices in 82 countries representing 96% of world exports

    • Trade specialists in more than 100 USEACs across the U.S. and USDOC HQ in Washington D.C.

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    Market Access and Compliance (MAC) Device Markets

    • Trade specialists covering countries worldwide

    • Understand broad trends in country/region

    • Often lead when industry needs advocacy or has country-specific market access issues

    • Offices for activities relating to multilateral agreements (EU, NAFTA, APEC)

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    Manufacturing and Services (MAS) Device Markets

    • Promotes competitiveness of U.S. industry, both domestically and internationally

    • Analyzes economic trends and important policy developments in specific industries

    • MAS includes OHCG for pharmaceuticals, biotechnology and medical devices

    • Data and descriptive analysis

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    MAS Office of Health and Consumer Goods Device Markets

    • Two Teams - Health Products and Technologies (HPT—pharmaceuticals, medical devices, and biotechnology) and Consumer Goods

    • HPT covers markets globally but focuses mainly on key markets [e.g. China, India, EU, Brazil, etc.]

    • HPT take a lead role on broader issues affecting multiple markets

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    Office of Health and Consumer Goods Device MarketsHealth Products and Technologies Team

    • Work closely with industry to identify and resolve trade issues

    • Work with other USG agencies [e.g. State, USTR, USFDA] to support agreements, voice concerns

    • Work within various forums to address impediments to trade

    • Support development of fair , transparent regulations in key markets

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    Office of Health and Consumer Goods Device MarketsHealth Products and Technologies Team

    • Organizes and conducts medical device regulatory training programs

    • Organizes and lead trade policy missions

    • Conducts research and report on issues impacting industry competitiveness

    • Provides information to industry on foreign markets

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    Primary Issues Device Markets

    • Regulatory and Reimbursement

    • Counterfeit medical products

    • Intellectual property issues

    • Procurement issues

    • Health Information Technologies

    • Product Specific issues (IVDs, Blood Plasma)

    • Domestic competitiveness

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    Issues - Regulatory Device Markets

    • Encourage transparency, fairness and harmonization with international best practices

    • Address Product Registration and Classification Issues

    • Ensure medical devices are not treated as pharmaceuticals

    • Encourage quality systems over type testing

    • Work toward acceptance of test data

    • Remove unnecessarily burdensome requirements on importers

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    Issues - Reimbursement Device Markets

    • Promote transparency and fairness

    • Discourage discrimination against U.S. imports

    • Discourage use of foreign reference pricing

    • Ensure consideration of advanced technologies

    • Content with issues arising from cost containment measures\HTAs

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    Key Markets - CHINA Device Markets

    • One of the world’s fastest growing market for medical devices (11-18%*)

    • Forum - JCCT Pharmaceutical and Medical Device Subgroup/Medical Device Task Force

    • Market presents various challenges for foreign suppliers: regulatory redundancies, transparency/centralized tendering, type testing, acceptance of test data, blood products ban, pricing

    • *Various sources

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    Key Markets - INDIA Device Markets

    • One of top twenty markets and rapidly growing driven by private sector investment

    • Forum – U.S. India High Technology Cooperation Group (HTCG) Biotech/Life Sciences Working Group

    • Issues: Uncertainties associated with evolving regulatory regime; product registration; labeling and testing; pricing

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    Key Markets – WESTERN EUROPE Device Markets

    • Long-standing, well established medical device trade relationship with the U.S.

    • Represents about 47 percent of U.S. exports

    • Past re-classification of devices

    • Planned changes in Medical Device Directives

    • Reimbursement

    • Additional regulations (e.g. REACH)

    • Cooperation on Third Country Market Access

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    Key Markets - GERMANY Device Markets

    • $12.4* billion medical products market ranked behind only U.S. and Japan, second behind U.S. in medical device imports

    • Dynamic healthcare sector with pros and cons

    • Reimbursement issues and significant downward pressure on prices

      *Source: Espicom Business Intel

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    Key Markets – LATIN AMERICA Device Markets

    • Regulatory and market conditions vary greatly by country

    • Most countries do not have full fledged regulatory systems – require USFDA approval AND approval from the country of origin (manufacturer)

    • Largest markets are Brazil ($2.9 B), Mexico (2.4B), Columbia ($457 M) and Chile ($368 M)*

    • * Source: Espicom Business Intel

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    Key Markets - BRAZIL Device Markets

    • Imports a high proportion of advanced med tech products

    • Efforts underway to engage Regulatory authority ANVISA in information exchange program

    • Forum – Commercial Dialogue

    • Examining possible nationalized system of price controls

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    Key Markets – SOUTH KOREA Device Markets

    • Imports about two thirds of total market

    • Challenging market access issues, but GOK is engaged

    • Forum - bilateral discussions associated with FTA

    • Pricing issues: “90% Rule”, transparency in reimbursement rates, planned use of functional category system, lack of transparency, valuation of innovative products

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    Key Markets - Other Device Markets

    • Japan - covered by MAC due to MOSS Talks

    • Australia - OHCG engaged in past re-registration and reimbursement issues

    • Association of Southeast Asian Nations (Asean) – good markets, 5-7 percent growth, regulations under development using GHTF documents, some regulatory and pricing issues

    • Taiwan – Fourth largest Asian market, moderate growth, extensive product regulatory requirements make it difficult to navigate

    • Mexico – ranked 17th globally ($2.4 B)

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    Cooperation with APEC Device Markets

    • OHCG has organized and conducted a series of APEC-funded seminars on medical device regulatory harmonization based on GHTF guidance documents

    • OHCG will coordinate two 2009 APEC-funded Medical Device Regulatory Harmonization visits for officials from APEC economies to Australia, Canada and U.S.

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    Online - WWW.TRADE.GOV Device Markets

    • Find a local office

    • Find statistics and analysis

    • Trade events and missions

    • Export counseling services

    • Find information on Advisory Committees

    • Report a trade barrier

    • File a trade complaint

    • Find a policy initiative

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    Contact OHCG at: Device Marketswww.ITA.DOC.GOV/TD/ * Richard_Paddock@ita.doc.govPhone: 202-482-0122*Phone: 202-482-3360Fax: 202-482-0975

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    U.S. Commercial Service Device Markets

    Global Healthcare Team from the

    US Commercial Service

    MDMA Webinar

    December 16, 2008

    Jennifer Loffredo

    Global Healthcare Team Leader

    U.S. Commercial Service

    U.S. Department of Commerce

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    U.S. Commercial Service Device Markets

    Our mission:

    To promote the export of goods & services from the United States, particularly by small- and medium-sized businesses

    To represent U.S. business interests internationally

    To help U.S. businesses find qualified international partners

    The U.S. Commercial Service is a program of the U.S. Department of Commerce’s International Trade Administration.

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    Trade specialists in 108 U.S. cities and more than 150 posts in 80 countries worldwide...

    Our Network & What it can do for you

    We can...

    • Locate international buyers, distributors & agents

    • Provide expert help at every stage of the export process

    • Help you to enter new markets faster and more profitably

    Products services l.jpg
    Products & Services in 80 countries worldwide...

    Market Research

    Gold Key Matching Service

    Trade Counseling & Advocacy

    International Partner Search

    Commercial News USA

    Catalog Exhibitions

    Trade Missions

    Global healthcare team l.jpg
    Global Healthcare Team in 80 countries worldwide...

    Network of Trade Specialists

    Events and programs

    Trade Leads

    Resource learn more

    How to contact us l.jpg
    How to contact us in 80 countries worldwide...

    Jennifer Loffredo

    Tel: 248-975-9600

    Fax: 248-975-9606



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    Trade Agreements in 80 countries worldwide...Monitoring and Compliance

    MDMA Webinar

    December 16, 2008

    Fernando Sanchez

    Trade Compliance Center

    U.S. Department of Commerce


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    What is the Commerce Department Trade Agreements Compliance Program?

    • A top priority for the Commerce Department

    • A one-stop program for coordination of USG efforts to remove foreign trade barriers.

    • Comprised of 3 Key Elements:

      • Pro-Active Monitoring

      • Compliance Action and Case Work

      • Outreach to U.S. Suppliers

  • Coordinated with USTR, Department of State and other agencies

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    Trade Agreements Monitoring Program?We Can Assist You in Overcoming Barriers Related To:

    • Excessive tariff and customs barriers

    • Discriminatory rules of origin, certificates of origin, or import licensing requirements

    • Burdensome standards, testing, labeling, or certification requirements

    • Lack of Intellectual Property Rights protection

    • Non-transparent government procurement procedures

    Submit your complaint to the tcc s trade complaint hotline l.jpg Program?

    Submit your complaint to The TCC’s Trade Complaint Hotline:

    Report a Trade Barrier

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    Team escalates the issue by bringing the full weight of the U.S Government to resolve the issue

    Implementation of Action Plan

    Team uses leverage of relevant trade agreements:

    • Bilateral discussions

    • Multilateral/ WTO fora

    • FTA negotiations

    • Additional Diplomatic Tools:

    • Meetings with foreign officials

    • Phone calls and letters

    • Non-papers

    • Demarches

    • Visits by Washington officials

    As a last resort: Team may recommend referral to USTR for WTO Dispute Settlement Body when appropriate

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    China – Imported Medical Device Regulatory Regime U.S Government to resolve the issue

    • China’s AQSIQ regulatory agency issues new draft regulation imposing new redundant and burdensome inspection regime for imported medical devices.

    • DOC partners with USTR and European Commission and engages China using correspondence, bilateral meetings, WTO TBT Trade Committee, and U.S. –China Joint Commission on Commerce and Trade.

    • After repeated consultations with AQSIQ and Ministry of Commerce, AQSIQ agrees to suspend the measure.

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    Japan – Medical Device Reviewers U.S Government to resolve the issue

    • U.S. medical technology industry association concerned that Japan is slow to approve medical device applications for the Japan market.

    • This “device lag” is partly due to low staffing levels at Japans’ ‘PMDA which reviews product applications.

    • Delays raise costs for U.S. device manufacturers forcing production lines of obsolete devices to remain active.

    • DOC urges Japan under U.S.-Japan Regulatory Reform Initiative and MOSS Agreement to increase PMDA staffing and expedite product approvals.

    • DOC and industry associations efforts result in increase in the number of PMDA reviewers.

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    Use our Free Resources U.S Government to resolve the issueAvailable from the TCC Web site:

    • TCC’s Trade Complaint “Hotline”

    • Checklist of common trade problems

    • Texts of over 270 trade agreements

    • Exporter Guides: concise explanations in laymen’s terms of key trade agreements

    • Market Access News

    • WTO Standards Notifications — “Notify U.S.“

    • Mailing List: Subscribers receive weekly “What’s New” e-mail updates on trade news

    • with IPR Information

    • Compliance Attaches

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    Contact the TCC at: U.S Government to resolve the tcc@mail.doc.govPhone: 202-482-1191Fax: 202-482-6097Fernando

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    Outline U.S Government to resolve the issue

    • The Trade Compliance Center and the Commerce Trade Agreements Compliance Program

    • Identifying Foreign Trade Problems

    • How We Take Action

    • Resources Available