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For those manufacturers and other stakeholders wanting more information in English from Japan’s Pharmaceuticals and Medical Devices Agency, your wait may soon be over. Read More
Devicemakers finding themselves having to change postmarketing requirements or other commitments need to inform the FDA and other regulators as soon as possible if they identify gaps in their plans. Read More
Tanzanian health regulators are reminding stakeholders that the second phase of registration for medical devices starts in less than three months. Read More
An advisory committee of the U.K.’s National Institute for Health and Care Excellence has issued a preliminary recommendation that the Spectra Optia, a blood component separator, could be cost effective for sickle cell anemia patients who require regular transfusions. Read More
Officials from the Agência Nacional de Vigilância Sanitária met with health and economic representatives from France last week to discuss the economic regulation of medical products and pricing models in Brazil. Read More
A container of gasoline stored next to orthopedic trays got devicemaker Medsource into hot water with the FDA and landed the firm a Sept. 24 warning letter for quality system deficiencies Read More
The FDA has offered its initial thinking on the best practices devicemakers can adopt when conducting animal studies in preparation for a possible IDE submission. Read More
The China Food and Drug Administration has issued four guidelines that give additional information for devicemakers awaiting good manufacturing practices inspections. Read More