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Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers the China Food and Drug Administration’s moves to speed registrations and approvals of medical devices and IVDs.Read More
The South Korean government reached an agreement with the nation’s medical device industry to adopt accelerated approval procedures for certain devices. Read More
China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to… Read More
Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials. Read More
Japan’s Pharmaceuticals and Medical Devices Agency has been ramping up its regulatory training activities with overseas regulators, and it inviting international regulators to a medical device seminar in Tokyo, Nov. 6-10. Read More
Australia’s Therapeutic Good Administration issued an update on its product review investigation of heater-cooler devices after more patients were found to be infected with Mycobacterium chimaera infections following heart surgery. Read More
Australia’s Therapeutic Goods Administration is urging devicemakers to meet with the agency before submitting conformity assessment applications. Read More
China’s high court called for severe criminal punishments for deliberately falsifying medical device clinical trial reports and other related documents,… Read More