Securing medical device approvals from China’s National Medical Products Administration for new products or changes to existing products often takes longer than planned, leading to delays in product launches that can hinder business operations and add significant costs.
EU Confidence In China Market Still On Downward Trend
Medtech Uncertainties Abound Says Chamber of Commerce-Roland Berger Survey
The anticipated business rebound for China after its post-COVID reopening of markets in 2023 has not materialized and structural market issues continue to affect EU firms' China sentiment.
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The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, the agency was able to participate virtually.
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Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?
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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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China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.
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Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his 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.
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Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.