Tradeology, the ITA Blog

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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.

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.