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Australia’s Therapeutic Good Administration has begun a postmarket review of all continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators including positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices on the Australian Register of Therapeutic Goods (ARTG). Read More
The Philippines FDA is advising devicemakers on documents needed as the agency transitions to new harmonized technical requirements as part of the Association of Southeast Asian Nations (ASEAN). Read More
The FDA has issued a warning letter to a Chinese devicemaker, Tianjin Bolang Science-Technology Development, listing nine violations for ear, nose and throat (ENT) devices exported to the U.S. Read More
Reports of a vulnerability in the Blackberry operating system used in certain medical devices and device manufacturing equipment as well in pharmaceutical manufacturing equipment has prompted the FDA to issue a cybersecurity alert. Read More
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance that clarifies when certifications for high-risk Class D in vitro diagnostics would need to involve an expert review panel. Read More
The FDA’s long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device was supposed to provide clarity, but there are still unanswered questions, according to attorneys at Ropes & Gray. Read More