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The China Food and Drug Administration has issued 90 industry standards – 14 mandatory and 76 recommended – covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
Effective July 1, devicemakers seeking to register products in Taiwan will need to have their quality system documents approved before submitting an application. Read More
With a June 30 device registration deadline fast approaching, Malaysia’s Medical Device Authority has released more guidance for manufacturers working to list their products. Read More
Devicemakers up for routine postmarket surveillance audits in Malaysia will get at least two weeks’ notice, the country’s Medical Device Authority says. Read More
While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some defined exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says. Read More
Devicemakers in India that exceed the U.S. FDA’s quality system expectations would receive fewer inspections and other incentives, under a pilot program announced last month. Read More
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
Indian devicemakers and governmental and nongovernmental partners have formed a steering committee to push forth a self-certification scheme for industry manufacturing best practices. The aim is to ensure the quality of Indian devices and eliminate sales of substandard products. Read More