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 Sub-regulation 4.1 This sub-regulation has been repealed.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......

Continue Reading