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Although the 25% tariffs initiated July 6 by the US Trade Representative will impact about $836m worth of medical technology entering the US from China, the administration late last week offered a process for gaining exclusions for specific products. AdvaMed members are “looking into” the process, the group said, and Medical Imaging and Technology Alliance members have already started to try to use it.
The EU medtech regulatory system is coming under fire again in the UK, being blamed for the vaginal surgical mesh scandal as action is taken to limit procedures. But this is a global problem.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty new guidance documents were posted on the tracker since its last update.
Proposals to classify high-end medical devices as drugs are out for comment in India.
While the Trump administration appears to have been partially persuaded by industry arguments that a host of China-made medtech items do not belong on a list of items earmarked for a 25% tariff starting July 6, there are still 27 devices – or accessories – that remain.
Five central medical device testing laboratories have been established in India under provisions of the country's new medtech regulations.
New streamlined regulatory pathways took effect for lower-risk devices in Singapore this month. See what Eugene Yoo, a top medtech industry advocate in the country had to say about the reforms here.
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