Regulatory Requirements: A Simple Guide for Australian Medical Device Distributors

So you’ve found a new medical device that is just what Australia needs? Follow these steps to better understand the regulatory requirements for selling medical devices in Australia.

Before we start, remember KD&A can assist you with all of the actions listed below, visit our Product Registration page for more information.

 FIRST THINGS FIRST

Ensure the device manufacturer will work with you to obtain Therapeutic Goods Administration (TGA) Australian Register for Therapeutic Goods (ARTG) inclusions (which allows you to put the device on the market. We recommend you get this in writing.

Check the device has certification issued by a European Notified Body (a CE Marking certificate).  Get a copy of the certificate and check that the device is covered.

Establish yourself as a Sponsor and make sure you understand the legal responsibilities of a Sponsor. The TGA define a Sponsor as person or entity who places therapeutic goods on the market in Australia) with the TGA. These can be found in the Australian Regulatory Guidelines for Medical Devices (ARGMD).  

 NEXT UP

Classify the medical device. Do this according to the Australian classification rules, found in the ARGMD.

Work with the device manufacturer to complete an Australian Declaration of Conformity (DoC). A DoC is a legal document which declares that the device and manufacturer conform to applicable Australian regulatory requirements.

Complete a Manufacturers Evidence Application using the device’s CE Marking certificate. Enter all applicable details into the TGA’s eBusiness System

Complete a device application based on the classification of the medical device and pay applicable TGA fees. Possibly undergo mandatory or non-mandatory audit of device documentation (from the manufacturer).

Obtain ARTG inclusion – place your device on the Australian market

 A FEW IMPORTANT HINTS

Ensure you have a post market system in place. Know what device records you need to keep and what to do if something goes wrong with the device on the market. Importantly, as the sponsor, you are responsible for the device on the Australian market.

Check other regulatory requirements. Such as the Therapeutic Goods Advertising Code 2002

Work within the bounds of your ARTG inclusion.   If the ARTG inclusion doesn’t mention a claim – it shouldn’t be made.

Stay in touch with the device manufacturer. Changes to a device can affect the validity of your ARTG inclusion. Ensure you know what changes, if any, are being made and if it effects your inclusion.

Don’t forget to pay the annual ARTG inclusion fees.

 If this all looks too hard….KD&A are here to help. We are product registration and TGA experts. We simplify the process for you, resulting in less nasty surprises and a smoother path to market.  Contact us, we’d love to hear from you.

To learn more about KD&A’s product registration services go to the product registration page or our clients page to hear about their experiences.