New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should an adverse event occur with a supplied device. Medsafe advise, recall actions are serious matters. They are also not isolated matters. Between 1-Jul-2012 and 30-Jun-2013 Medsafe was advised of 705 medical device market actions, resulting in 101 recalls, 173 corrective actions, and 25 alerts. The balance of actions related to devices where the affected lots/batches/versions were not supplied in New Zealand, or where the device......
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The Mutual Recognition Agreement between Australia and the European Union (EU), the EC MRA, facilitates medical device sponsors (entities or individuals who place medical devices on the market in Australia) to use CE Marking certificates as evidence of conformity to Australian regulatory requirements for some medical devices. Since being signed in 1998, the Agreement has provided a much shorter path to market in Australia for most CE Marked medical devices. However, the EC MRA has recently undergone changes which restrict previously covered devices. Changes came into affect on January 1 2013 and......
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From July 1 2012, hip, knee and shoulder joint implants will be classified as Class III medical devices according to the Therapeutic Goods (Medical Device) Regulations 2002. The change comes after the Therapeutic Goods Administration (TGA) consultation paper, Reforms in Medical Devices Regulatory Framework, was released in late 2010. Australia is not the only country to make such changes, a number of overseas countries have reclassified these products in an aim to improve safety and quality for patients....
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