Why International Medical Regulations?

This series of four webinars focuses on major markets for U.S. medical products. Changes to medical regulatory systems in these markets impact U.S. companies’ success, and the goal of these webinars is to help U.S. exporters ensure they are up to date on upcoming and recently implemented medical regulations in these key markets.

Main topics to be discussed include:

  • Medical products regulatory body for the market
  • Best practices to approaching the market
  • Upcoming or recent changes to regulations/standards that might affect market access for U.S. medical products exporters
  • Resources for U.S. companies if they have an issue with a given regulation/standard
  • Market opportunities for U.S. exporters in the market

Event dates

Date

Focus

Registration

Agenda/Speakers

**NEW DATE** Thursday, March 14 at 7:00pm ET (Friday March 15 at 7:00am CST)

China

Registration for this session is closed.

Thursday, March 21 at 11:00am ET

Canada

Registration for this session is closed.

**NEW TIME AND DATE** 11:00am ET/8:00am PT (8:30pm IST) on Tuesday, March 26

India

https://go.usa.gov/xErWn

Thursday, April 4 at 11:00am ET

European Union

https://go.usa.gov/xErWE

Agenda and Speakers

**NEW TIME AND DATE** India - Tuesday, March 26 at 11:00am ET/8:00am PT (8:30pm IST)

Topic

Speakers

  • Medical market overview

o Opportunities with subsector highlights

o Government procurement process

o Payment/reimbursement mechanisms

o Rural v. urban divide

o Taxation/tariffs on import of medical devices

o Government initiatives in the sector

o Doing business in India

  • Mr. Ravi Menon, Senior Business Adviser, APAC Healthcare, SKP Group
  • Medical products regulatory body for the market

o Regulatory environment of Medical Device market in India

o Market challenges and barriers from a U.S. company perspective

  • Ms. Kirti Arora, Associate Director Regulatory Affairs and Quality Assurance, Boston Scientific
  • Upcoming or recently implemented changes to regulations/standards that might affect market access for U.S. medical products exporters

o Government pricing controls

o IPR, legal metrology

o Inflationary trends, standards

o Market access issues

o GOIs health initiative: Ayushman bharat

  • Resources for U.S. companies if they have an issue with a given regulation/standard and what resources are available to help U.S. exporters navigate and/or discuss an issue
  • Tyler Hubler, U.S. Department of Commerce Office of Trade Agreements Negotiations and Compliance (TANC)
  • U.S. Commercial Service
   

**NEW DATE** China – Thursday, March 14 at 7:00pm ET (Friday March 15 at 7:00am CST)

Topic

Speakers

  • Medical Market in China
  • Xiaoli Pan, Senior Commercial Specialist, U.S. Consulate General Shanghai, China
  • Best practices to approaching the market
  • Xiaoli Pan, Senior Commercial Specialist, U.S. Consulate General Shanghai, China
  • Medical products regulatory body for the market

o In Spring 2018, the China Food and Drug Administration (CFDA) changed its name to the National Medical Product Administration (NMPA). The NMPA (CFDA) changes will offer both opportunities and challenges to many foreign companies targeting the Chinese market.

§ Major NMPA (CFDA) Updates in 2018 (Hainan policy, new classification rules, legal agent, registration holder system, overseas clinical data etc.)

§ NMPA Registration Updates in the new era

§ NMPA Clinical Updates in the new era

§ Post-Market Compliance Updates in the new era

  • Grace Fu Palma, CEO, ChinaMed Device, LLC
  • Upcoming or recently implemented changes to regulations/standards that might affect market access for U.S. medical products exporters

o Era of transformation: 2018 NMPA (CFDA) Major Regulation Updates

o NEW Registration Holder System for Medical Devices in China

o NEW post-market surveillance requirements in China

o Latest clinical requirements in China

o Putting a plan in place for all the NEW changes in China

  • Grace Fu Palma, CEO, ChinaMed Device, LLC
  • Resources for U.S. companies if they have an issue with a given regulation/standard and what resources are available to help U.S. exporters navigate and/or discuss an issue
  • Ana Reed, U.S. Department of Commerce Office of Trade Agreements Negotiations and Compliance (TANC)
  • Market Event: China Medical Equipment Fair (CMEF) CEO Program
  • U.S. Commercial Service
   

Canada – Thursday, March 21 at 11:00am ET

Topic

Speakers

  • Medical Market in Canada
  • Connie Irrera, Commercial Specialist, U.S. Consulate General, Montreal, Canada
  • Medical products regulatory body for the Canadian market
  • Health Canada
  • Recently implemented changes to regulations/standards that might affect market access for U.S. medical products exporters
  • Health Canada
  • Resources for U.S. companies if they have an issue with a given regulation/standard and what resources are available to help U.S. exporters navigate and/or discuss an issue
  • Health Canada
  • U.S. Department of Commerce Office of Trade Agreements Negotiations and Compliance (TANC)
   

European Union – Thursday, April 4 at 11:00am ET

Topic

Speakers

  • Medical Device Regulation in the European Union: Post-2020 Landscape

o Overview of new EU Medical Device Regulation

o CE Mark

o Impact on Notified Bodies/Authorized Representatives

  • Antonio Dai-Pra, Senior Trade Advisor – Market Access, U.S. Mission to the EU
  • Software/Medical Apps: Classification and Challenges of the MDR

o How to classify software as a medical device under the current European Medical Device Directive and the future Medical Device Regulation

o When a software application becomes a medical device

o Key requirements under the new Medical Device Regulation

  • Oliver Hilgers, Authorized Officer, Medical Software / Active Medical Devices, CE plus GmbH
  • USCS Health IT Affinity Group – Resources for U.S. Companies in Europe
  • Marta Haustein, Senior Commercial Specialist, Health IT Affinity Lead, U.S. Embassy, Vienna
  • Resources for U.S. companies if they have an issue with a given regulation/standard and what resources are available to help U.S. exporters navigate and/or discuss an issue
  • U.S. Department of Commerce Office of Trade Agreements Negotiations and Compliance (TANC)

Location
WebEx* Webinar

Each webinar will last for approximately 1.5 hours

* To join an event, you will need to download, install, and configure the “WebEx Event Manager”. The first time you join or start an event, the “WebEx Event Manager” will automatically be installed. If you are using a non-Windows or Macintosh operating system or browser other than Internet Explorer or Firefox, a Java Client will be downloaded automatically when you join an event. To manually download the “WebEx Event Manager”, click on https://www.mymeetings.com/netconferencing/WBS31.11.2.7_Plug-Ins.php. Under “Event Center Application”, select the installer that matches your operating system. You must have administrator privileges on your computer to use the installer.

Cost
$50 per webinar

These webinars will be recorded, and your registration also gives you access to the recorded webinar.

U.S. Commercial Service Global Healthcare Team

The U.S. Commercial Service Global Healthcare and Life Sciences Team focuses on assisting U.S. healthcare technologies companies in their international development activities. Global Healthcare Team members located in India, China, Canada and the EU will be on these webinars as well to discuss additional opportunities and U.S. Commercial Service support available to help U.S. exporters succeed in these markets.

For any immediate questions on this series or registration, please contact U.S.-based Healthcare Team members: Margaret.Gottlieb@trade.gov or Taylor.Little@trade.gov



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