Medical Device Product Registration and Approval in Australia
MEDICAL DEVICE REGULATION IN AUSTRALIA
Medical devices are regulated by the Therapeutic Goods Administration (TGA) in Australia whose aim is to ensure the Australian community has access within a realistic time frame to therapeutic goods by evaluating and monitoring devices that are of an acceptable standard. Medical devices are regulated under the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN AUSTRALIA
Therapeutic goods (medical devices) must be included on the Australian Register of Therapeutic Goods (ARTG) before the device can be supplied in Australia.
Medical device (non-IVD) in Australian are classified into 4 categories namely class I, IIa, IIb and III (Similar to EU Classification).
IVD products in Australia are classified into class 1 IVD, 2 IVD, 3 IVD, and 4 IVD.
For medical devices (except class I devices, non-sterile and non-measuring), a manufacturer must hold an acceptable Conformity Assessment Certificate for the medical device to be included on the ARTG.
For devices with EC certification, the ARTG inclusion process will be much easier. The EC Conformity Assessment certification should be issued by an acceptable EU Notified Body in accordance to the Medical Device Directive 93/42/EEC (MDD) or In-Vitro Diagnostic Medical Devices Directive (IVDD), or ISO 13485 Certificates for IVD.
High-risk medical devices require TGA Conformity Assessment and the EC certification is not an acceptable evidence of compliance.
Medical devices must be included on the ARTG before the device can be imported and/or supplied in Australia.
Example of Approval