Medical Device Registration in Australia

There is a constant growth in the Australian medical device industry. More than 25,000 devices have been launched so far. But these medical devices need to be registered before they get launched in the market. The Therapeutic Goods Administration (TGA) is the government body that regulates therapeutic goods, including medical devices, in Australia.

The TGA adhere with a set of fundamental principles to make sure that only safe, effective and high quality medical devices are supplied to the market. They also ensure that there is a implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities.

There are four key players who play a major role in the Australian Regulatory system:

1. Manufacturers: They manufacture medical devices in Australia and overseas.

2. Sponsors: They help manufacturers to import, export or manufacture medical devices. Sometimes the manufacturer can also act as a sponsor.

3. TGA: This is a government body that has regulatory control of therapeutic goods and medical devices in Australia.

4. Medical Device Consultants: They basically act on behalf of manufacturers or sponsors to register their medical devices in Australia.

It is very important for the manufacturers to produce safe, quality and effective medical devices. There are certain principles which the manufacturers should comply by:

1. The use of medical device will not compromise on the health and safety of the user.

2. It will be designed and constructed in accordance with the safety principles.

3. It should be appropriate for the intended purpose

4. It should not to be adversely affected by transport or storage

5. It should ensure long term safety

6. All the information should be provided with the device.

When the device complies with all the essential principles, then a Conformity Assessment Certification is awarded by the TGA. This certificate demonstrates that a conformity assessment procedure has been appropriately applied and the device is ready to be launched.

What is a Medical Device Regulatory Process?

The regulatory process is quite simple if you abide by the rules and regulations set by the TGA. All the manufacturers should obtain a Conformity Assessment Certificate from the Therapeutic Goods Administration. The overseas manufacturer should obtain an MRA/CE certificate and an Australian Declaration of conformity. Apart from Class I (non measuring and non-sterile) device applications, all the other devices needs a conformity assessment certificate. The next step is that the manufacturer gives the suitable Conformity Assessment Certificate to the sponsor. Then the sponsor or the medical device consultants submits the certificate through the DEAL system.

TGA then reviews all the documents that is submitted by the sponsors and accepts them. Basically all the devices are properly audited by the government body TGA. Then Sponsor submits medical device application with the appropriate application fees through the DEAL system. TGA accepts the application and includes the device in the Australian Register of Therapeutic Goods (ARTG). Post market monitoring is regularly conducted by the TGA after the launch of the medical device in the market. For more information, visit RQSolutions.