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Devicemakers have until June 30 to register their products in Malaysia and regulators there are already anticipating a backlog of applications. Read More
Countries looking to develop a medical device regulatory regime should take a total lifecycle approach starting with listing products and implementing premarket controls, the Asian Harmonization Working Party says. Read More
Manufacturers of general wellness products wondering how the U.S. FDA might regulate their goods should check how the agency deals with similar devices, an attorney says. Read More
The U.S. FDA should finalize guidance documents on premarket and postmarket data collection, the proposed laboratory-developed tests framework and adverse event reporting, and biocompatibility standards before attacking other priorities, AdvaMed says. Read More
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
Important details on unique device identification, such as transition times, are missing from the EU’s draft medical device regulation, a major industry group says. Read More