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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

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



global medical device market growth potential
Global Medical Device Market Growth Potential
  • 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

Global Medical Device Market ($USB)

Source: Espicom Business Intelligence

global medical device market u s position
Global Medical Device Market— U.S. Position
  • 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
u s medical device exports 2007
U.S. Medical Device Exports (2007)

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

global market share by country
Global Market Share by Country


























ita s mission
ITA’s Mission

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

ita s structure
ITA’s Structure
    • 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)
international trade administration
International Trade Administration



Market Access

& Compliance


& Services



Global Network of

Trade Specialists






u s and foreign commercial service
U.S. and Foreign Commercial Service
  • 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.
market access and compliance mac
Market Access and Compliance (MAC)
  • 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)
manufacturing and services mas
Manufacturing and Services (MAS)
  • 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
mas office of health and consumer goods
MAS Office of Health and Consumer Goods
  • 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
office of health and consumer goods health products and technologies team
Office of Health and Consumer GoodsHealth 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
office of health and consumer goods health products and technologies team15
Office of Health and Consumer GoodsHealth 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
primary issues
Primary Issues
  • Regulatory and Reimbursement
  • Counterfeit medical products
  • Intellectual property issues
  • Procurement issues
  • Health Information Technologies
  • Product Specific issues (IVDs, Blood Plasma)
  • Domestic competitiveness
issues regulatory
Issues - Regulatory
  • 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
issues reimbursement
Issues - Reimbursement
  • 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
key markets china
Key Markets - CHINA
  • 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
key markets india
Key Markets - INDIA
  • 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
key markets western europe
  • 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
key markets germany
Key Markets - GERMANY
  • $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

key markets latin america
  • 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
key markets brazil
Key Markets - BRAZIL
  • 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
key markets south korea
Key Markets – SOUTH KOREA
  • 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
key markets other
Key Markets - Other
  • 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)
cooperation with apec
Cooperation with APEC
  • 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.
online www trade gov
  • 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

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

u s commercial service
U.S. Commercial Service

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

u s commercial service31
U.S. Commercial Service

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.

our network what it can do for you
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
Products & Services

Market Research

Gold Key Matching Service

Trade Counseling & Advocacy

International Partner Search

Commercial News USA

Catalog Exhibitions

Trade Missions

global healthcare team
Global Healthcare Team

Network of Trade Specialists

Events and programs

Trade Leads

Resource learn more

how to contact us
How to contact us

Jennifer Loffredo

Tel: 248-975-9600

Fax: 248-975-9606



trade agreements monitoring and compliance

Trade Agreements Monitoring and Compliance

MDMA Webinar

December 16, 2008

Fernando Sanchez

Trade Compliance Center

U.S. Department of Commerce


what is the commerce department trade agreements compliance program
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
trade agreements monitoring we can assist you in overcoming barriers related to
Trade Agreements Monitoring 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

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

china imported medical device regulatory regime
China – Imported Medical Device Regulatory Regime
  • 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.
japan medical device reviewers
Japan – Medical Device Reviewers
  • 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.
use our free resources available from the tcc web site www trade gov tcc
Use our Free Resources Available 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

Contact the TCC tcc@mail.doc.govPhone: 202-482-1191Fax: 202-482-6097Fernando

  • The Trade Compliance Center and the Commerce Trade Agreements Compliance Program
  • Identifying Foreign Trade Problems
  • How We Take Action
  • Resources Available