Tag: Australia medical device regulatory framework


Australian Medical Device Conformity Assessment Regulations updated by the TGA

In July 2021 the Therapeutic Goods Administration (TGA) published significant updates to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). Access the current version of the Regulations via the TGA website. WHAT HAS BEEN UPDATED? Sub-regulation 4.1 This sub-regulation has been repealed. So what does this mean? It is no longer a requirement for the manufacturer of medical devices which fall into the categories listed below, to hold a TGA Conformity Assessment (CA) certificate as the only accepted evidence of conformity, before submitting your application for inclusion on the Australian Register......

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TGA’s Medical Device Regulatory Changing Landscape

In 2020, the TGA are implementing a range of changes to the medical device regulations due to a number of reasons; some of which include changes to the European device regulations and new technologies now considered medical devices. The TGA have released an Action Plan, which has a 3-strategy approach to implementing the changes. The Action Plan Strategy 1 – Improving how new devices get on the market The TGA is strengthening its assessment processes and oversight of how devices are approved for use on the Australian market. Better assessment of new......

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