Posts Tagged ‘U.S. Commercial Service’

h1

Medical Device Regulations are Changing in Canada and the EU, Prepare Now to Maintain Market Access

June 11, 2018

This post contains external links. Please review our external linking policy.

Susan Crawford is the communications specialist for the U.S. Commercial Service’s Global Healthcare Team. The U.S. Commercial Service is the trade promotion arm of the U.S. Department of Commerce’s International Trade Administration.

Webinar: Preparing for the MDSAP

Date:  June, 28, 2018
Time: 
2:00 – 3:00 p.m. EDT
Registration:
https://go.usa.gov/xQVSh
More Information:
Connie.Irrera@trade.gov

Healthcare regulations are changing in major medical device export markets including Canada and the European Union (EU), and the U.S. Commercial Service (CS) Global Healthcare team is helping to inform U.S. companies about these changes and ensure that exporters have the resources they need to access these important markets.

Canada is launching a new Medical Device Single Audit Program (MDSAP) and all medical devices in Canada must be deemed safe and effective, including software accompanying any medical device. As of January 1, 2019, only MDSAP certificates will be accepted. Therefore, exporters will need to register under the new program to maintain the ability to sell medical devices in Canada in 2019.

The MDSAP Consortium includes Australia, Brazil, Canada, Japan, and the United States; however, Canada’s Medical Devices Regulations (SOR/98-282) are unique from other regions covered by the MDSAP Consortium in that it is currently the only one that will use MDSAP certificates to make determinations on Class II, III, and IV devices licenses. As Health Canada notes, “All manufacturers must transition from CMDCAS to MDSAP certificates to meet the quality management system requirements of the Medical Devices Regulations.”

To assist exporters with understanding the new regulation, the Global Healthcare Team is holding a webinar about MDSAP registration and requirements on June 28, 2018, featuring Frédéric Hamelin, Manager of the Quality Systems Section of the Medical Devices Bureau at Health Canada. To register for the webinar, please click here: https://go.usa.gov/xQVSh. For more information, contact Canada-based CS Commercial Specialist Connie Irrera at Connie.Irrera@trade.gov.

Medical regulations have already changed in the EU regarding the treatment of healthcare IT applications, post-market surveillance and liabilities borne by manufacturers. The new Regulation 2017-745 took effect in May 2017, and is the master regulation with which all imported medical devices will need to comply. The new rules will apply after a transitional period which will be three years after entry into force for the Regulation on medical devices (spring 2020), and five years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices, according to the EU Commission.

CS Global Healthcare Team Acting Director Taylor Little (CS New Hampshire) and team members David Edmiston (CS Minneapolis, MN) and Melissa Grosso (CS Middletown, CT) are educating U.S. firms and colleagues about these upcoming regulatory changes and the potential impact on U.S. medical device exports. The three international trade specialists recently completed the Regulatory Affairs Certificate Program in Medical Devices from the Regulatory Affairs Professional Society (RAPS), the largest global organization for those involved with the regulation of healthcare and related products.

“We want to prevent a situation in which a small company loses access to an export market because they were not aware of impending regulatory changes,” Little said.

For more information about the CS Global Healthcare Team, visit our website and click here to find a healthcare trade specialist near you.

 

Resources for Exporters

The U.S. Commercial Service Global Healthcare Team offers a variety of resources to educate exporters about market opportunities and trends for healthcare-related products and services.

Global Healthcare Team Website: https://2016.export.gov/industry/health/

Health Technologies Resource Guide: https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_083726.asp 

Top Markets Series Reports

Additional Resources

h1

Women in International Trade, District Export Council, U.S. Department of Commerce Team Up for Program on Women Seizing New Opportunities with Africa

May 2, 2018

This post contains external links. Please review our external linking policy.

This is a guest blog submitted by the Association of Women in International Trade, Washington, DC.

Photo of participants from the Women Seizing New Opportunities with Africa: Driving U.S.-Africa Exports, Investment and Partnerships panel posing with Assistant Secretary for Global Markets and Director General of the U.S. and Foreign Commercial Service Erin Walsh. The diverse panel featured voices from public and private, U.S. and African, and for-profit and non-profit companies.

Participants from the Women Seizing New Opportunities with Africa: Driving U.S.-Africa Exports, Investment and Partnerships panel pose with Assistant Secretary for Global Markets and Director General of the U.S. and Foreign Commercial Service Erin Walsh. The diverse panel featured voices from public and private, U.S. and African, and for-profit and non-profit companies.

On March 15, the Association of Women in International Trade (WIIT) and the Organization of Women in International Trade (OWIT), in partnership with the Virginia/Washington, DC District Export Council (DEC) and the U.S. Department of Commerce’s U.S. Commercial Service, Northern Virginia office, hosted a program on U.S.-Africa partnership and women’s economic empowerment.

Women Seizing New Opportunities with Africa: Driving U.S.-Africa Exports, Investment and Partnerships was held in connection with International Women’s Day, and highlighted growing opportunities for women-owned businesses to expand their export bases into Africa.

U.S. Secretary of Commerce Wilbur Ross delivered the opening remarks, and Assistant Secretary for Global Markets and Director General of the U.S. and Foreign Commercial Service Erin Walsh moderated the subsequent panel discussion, featuring voices from public and private, U.S. and African, and for-profit and non-profit companies.

Addressing the roughly 150 guests in attendance, Secretary Ross shared his insights on the growing opportunities for women-owned business to go global. He specifically advocated for women to take advantage of the exciting opportunities that exist for American businesses to find new markets and effectively compete in Africa.

Following Secretary Ross’s remarks, Assistant Secretary Walsh opened the panel discussion, congratulating the Washington, D.C. WIIT for celebrating its 30-year anniversary in 2017. She noted that only 12 percent of U.S. exporters are women-owned, compared to 20 percent of exporters worldwide. Further, only one percent of all U.S. SMEs export overseas.

“We must change these statistics,” Walsh said.

The following people participated in the panel discussion:

  • E. Arikana Chihombori-Quao, Permanent Representative of the African Union Representational Mission to the United States;
  • Mary Bezzini, President of Godman Power Group, Inc.;
  • Mucha Mlingo, President of OWIT Nairobi;
  • Thione Niang, Founder of the Give1Project;
  • Florie Liser, President & CEO, Corporate Council on Africa.

Interested in Exporting to Africa?

If you are considering entering or expanding into African markets, there are many ways in which the Department of Commerce’s U.S. Commercial Service can help you achieve your goals.

Country commercial guides are available for most African countries. To talk to someone locally about exporting, contact the U.S. Commercial Service in your area.

You can also use the U.S. Commercial Service to help you develop an export strategy and promote your brand for targeted African countries.