New Anti-Corruption Focus In Mexico May Include Medtech Scrutiny
Recently inaugurated Mexican President Andrés Manuel López Obrador campaigned on a promise to tackle the country’s corruption issues. Medtech Insight spoke to attorney Nicholas Berg, of Ropes & Gray, about what this may mean for device manufacturers doing business in Mexico.
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The company came under a Department of Justice inquiry for overseas bribery in 2012, and new allegations in 2014 have delayed a final close-out of the case. The formal agreements expired on March 26, but Biomet says it expects the investigation to continue.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.
The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.