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Legislation establishing a device regulatory framework in Malaysia took effect just six months ago, and the Medical Device Authority wants to hear from stakeholders on how implementation and the transition to establishment licensing and device registration is going. Read More
Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says. Read More
The FDA granted AtheroMed’s Phoenix Atherectomy System 510(k) clearance to treat vessels below the knee in patients with peripheral artery disease. Read More
American Aesthetics Medical Supply, a Dallas-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter. Read More
Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says. Read More
Vietnam’s Ministry of Health has issued a decree specifying requirements for the manufacture, sale, services, information and advertising of medical devices. Read More