AdvaMed Offers Plan To Strengthen Medtech Supply Chain

Medtech trade group AdvaMed is offering a list of recommendations to beef up the nation’s medical technology supply chain. Public-private partnerships are central to the group’s plan.

STRATEGIC PLAN
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Steady and reliable supply chains are critical to the medtech industry. But as the pandemic revealed, when the flow of those supply chains is disrupted it can impact more than bottom lines – it can cost lives.

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South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.