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Australia’s Therapeutic Goods Administration is warning of the potential need for revision surgery due to parts becoming detached in Smith & Nephew’s Tandem Bipolar Hip System. Read More
Australia’s Therapeutic Goods Administration released guidance on its website to help sponsors through the process of registering Class IV in vitro diagnostics in the Australian Register of Therapeutic Goods. Read More
One of the most important considerations device manufacturers will make before entering China is whether the device will be manufactured locally or not. Read More
Japan’s Mitaka Kohki failed to establish design control procedures, CAPA procedures, equipment calibration procedures, and documentation was found lacking for numerous critical processes during an inspection of the Tokyo-based facility. Read More
Australia’s Therapeutic Goods Association is updating Siemens Healthcare Diagnostics’ Instructions for Use statement for its prostate-specific antigen assays used with ADVIA Centaur systems. Read More
Medtronic Australasia, in consultation with Australia’s Therapeutic Good Administration, issued a hazard alert for two models of its Neuromodulation Deep Brain Stimulation system pocket adaptors in Australia. Read More
Indian regulators have decided to abandon a proposed law that would have amended parts of India’s Drugs and Cosmetic Act of 1940, to pursue more extensive revisions to create a separate device regulation. Read More
Inner Mongolia has created a framework to establish an independent FDA in an effort to monitor the safety and efficacy of products sold within the territory. Read More
India has approved funding for the country’s first medical device park. It will have specialized laboratories, warehousing, testing centers and up to 150 independent manufacturing units. Read More