This Country

Australia

Home --> Registration --> Asia and Others --> Australia

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

 
Source: TGA
Need more details? Contact us

We are here to assist. Contact us by phone, email or fill up an enquiry form

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle
  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle

Services

Contacts

Call us:

   : +65 6909 0396

   : +65 9067 1432

 

Email us: info@arqon.com

Resources

© 2018 ARQon All Rights Reserved. 

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle