What is a valid ISO 13485 QMS certificate accepted by the TGA? International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The TGA accepts ISO 13485 certificates issued by Notified Bodies or an International Accreditation Forum (IAF) certified conformity assessment body. Refer to the Table provided below for a summary of TGA accepted manufacturer’s evidence for IVD medical devices. What is changing? The COVID-19 pandemic had a significant impact on the IVD industry which was burdened with......
Continue Reading
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 Sub-regulation 4.1 This sub-regulation has been repealed.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
In Australia the Therapeutic Goods Administration (TGA) overseas the medical devices which are placed on the market. The TGA enforces the Therapeutic Goods (Medical Devices) Regulations 2002 as amended. Guidelines to the Regulations can be found at Australian Regulatory Guidelines for Medical Devices (ARGMD). Pre-market: Determine if your product is a medical device? Does your product meet the definition of a medical device, whereby the product is intended to be used on humans for any of the following; Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or......
Continue Reading