Australia Medical Devices Regulations

A manufacturer who is willing to manufacture, import, sell or distribute medical devices in European Union (EU), should acquire or apply for relevant CE certification for that medical device. A CE mark accredits the medical device with the regulations laid and accepted by the EU and enables commercialization of the product in the European member states. In parallel, the manufacturer will be responsible for maintaining regulatory compliance QMS and making sure product is bearing the relevant CE mark.

TGA Medical Devices

Classification and Registration on Medical Devices and IVD in Australia

Medical devices are separated into 5 classes: Class I, Class IIa, Class IIb, Class III, and Active Implantable Medical Devices (AIMD). In Vitro diagnostic devices (IVD) are divided into four separate classes: Class I, Class II, Class III, and Class IV.  

There are three documents that are required to register a medical device in Australia: a conformity assessment certificate which can be issued by TGA, a Declaration of Conformity, and a submission to include the medical device in the Australian Register of Therapeutic Goods(ARTG). 

Medical Devices Registration

Athreva can assist with Australia TGA medical device registration by:

  • Assessing the Australian TGA registration requirements for your devices 
  • Researching the appropriate GMDN codes for your medical devices 
  • Conducting a Technical File assessment to ensure completeness 
  • Assisting with compilation or assessment of clinical summary 
  • Submitting medical device applications to the TGA 

Medical Devices Regulatory Strategy in Australia

The Therapeutic Goods Administration (TGA) is the competent government department for medical devices in Australia. TGA is a group of the Australian Government Department of Health and is responsible for managing the provisions of the legislation under the Therapeutic Goods Act 1989. This act includes both medical devices and AIMDs.

Athreva assists the following regulatory strategy services:

  • TGA regulatory background
  • Product assessment
  • Device classification
  • In-country representation requirements for Australia
  • Medical device registration requirements
  • Medical device labeling requirements
  • Cost and timeframes
  • Regulatory roadmap to market authorization
  • Post-market surveillance/vigilance requirements
Legal Representative

Device Labeling & Promotional Material

  • Support for labelling design
  • Gap analysis of existing label to meet local requirements
  • Advice on promotional material design

QMS Compliance

Determining labeling information & symbols, technical dossier templates, quality system procedures (QSP) or SOPs, device regulations, vigilance & harmonized standards

Legal representation/ Authorized Representation for Medical Devices in Australia

Athreva has the experience and resources to help you succeed in Australia. We understand the importance of individual representation and our experts in Australia have the regulatory expertise to serve the interests of your Devices. As your Registrant, we can:

  • Register your medical devices and IVD with the Therapeutic Goods Administration (TGA) before commercialization
  • Ensure that your Technical File is made accessible for inspection by the TGA
  • Our regulatory experts to interact between you and the TGA

Secure online access to Labeling Information & Symbols, Technical Dossier Templates, Quality System Procedures (QSP) or Standard Operating Procedures (SOP), Medical Device Regulations, Vigilance, Classification Guidelines, Harmonized Standards, and more.

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