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Compliance Corner: Being MDSAP-Ready Helpful While FDA Foreign Inspections Paused, Expert Says

 
• By Shawn M. Schmitt

King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.

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A medical device maker’s OUS facilities aren’t out of the inspectional woods just because the US Food and Drug Administration isn’t currently inspecting foreign manufacturing plants because of the COVID-19 pandemic, an industry expert warns.

“Unless your foreign site is only shipping to the United States, it’s quite likely that you’re getting certified as well to a standard like ISO 13485, which … is the...

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.