New provisions addressing harmonization of device regulations across US, Mexico and Canada’s borders – including regulators’ ability to use technically equivalent standards – were included in a newly concluded US-Mexico-Canada (USMCA) trade accord that was agreed to in principal by the US Oct. 1. The accord is intended to replace the North American Free Trade Agreement (NAFTA).
New NAFTA: US Agrees To Trade Accord With Canada And Mexico, Including Medtech-Backed Provisions
Under a US-Mexico-Canada trade accord agreed to by the Trump administration Oct. 1, the three countries would harmonize medical device regulations, accept the Medical Device Single Audit Program (MDSAP) and grant marketing authorizations across international boundaries. The deal still needs sign off by the US Congress and the Mexican and Canadian governments.
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In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
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The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
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The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.
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Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.
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People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
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A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.