How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...

The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold the ...

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties. The ...

Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy ...

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Completing a process started about 13 years ago, new rules for how medical devices are evaluated and brought to market in the European Union (EU) came into full force last Wednesday—with implications ...

On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...

Despite the fresh set of guidelines, experts said that technologies like AI are increasingly being used in MedTech sector, ...

MDR Certification Strengthens Resyca's Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS Newswire / January 28, 2025 / Resyca BV, a pioneering leader in the development ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL ®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the ZOLL AED 3 ® defibrillator is approved ...