The medical device industry in Australia is booming in the current times. To start it as a business, one must have a proper registration done. Medical device registration in Australia is undergone by the Australian Register of Therapeutic Goods (ARTG). Any foreign manufacturer who plans to set up his Medical devices business in Australia shall assign a Sponsor as applicant, a Local Authorized Representative who will guide with the documentation required for the registration process to the concerned official. In this article we will know more about the process of Medical registration in Australia which covers: What are Medical devices?, Authorities involved in the registration process, Basic principles that apply to all Medical devices, Process of Medical Device Registration in Australia.
What Are Medical Devices?
According to the Therapeutic Goods Act, 1989, “Medical devices‘ are defined as any apparatus, instrument, machine, material or any related article, used by the Manufacturer, either individually, wholly or in combination, used for the purpose of curing, diagnosing, treating or ailing any disease, harm or injury caused. The definition of Medical devices does not apply on or in the human body by pharmacological, metabolic or immunological means.
Authorities Involved In The Process Of Medical Device Registration in Australia
The following are the authorities involved in the process of Medical Device Registration in Australia:
- The sole responsible authority for registering Medical devices and in In-Vitro Diagnostics (IVD) is the Australian Register of Therapeutic Goods Administration (ARTG), regulated by the Therapeutic Goods Administration (TGA). The Therapeutic Goods Administration (TGA), is a part of the Department of Health and Aging and is regulated by the Government of Australia. It controls medical device registration in Australia.
- To make the registration process an easy affair, one must appoint an Australian Sponsor, a Local Official who acts as an alliance between the Manufacturer and the Therapeutic Goods Administration (TGA). A Sponsor does not act as an importer, exporter or Manufacturer but he acts as a bridge to obtain all the detailed information and informs to the TGA. In case of any adverse situation, the sponsor reports to the TGA authority.
- The Manufacturer is a person who produces, assembles and constructs all the medical devices, keeping in conformity with the Global Medical nomenclature code, can select a proper assessment procedure, and also prepare a declaration of conformity.
- The Therapeutic Goods Administration (TGA) is the regulatory authority that governs therapeutic apparatus which also includes medical devices.
Basic Elementary Principles That Applies To All Medical Devices
The general principles that applies are as follows:
- The Medical devices shall be designed and structured in such a manner that it must reconcile with the safety principles;
- Medical devices shall be used so as to not compromise the health of individuals;
- Medical devices shall be made suitable to all intended purposes and long-term safety;
- Medical devices shall be built in such a manner so that it does not have any adverse impact on the environment, it must come with protection against radiation.
- Designs for the devices shall be made such, so that it does get affected in case of movement by transport or at the time of storage.
- All the material facts and information pertaining to the devices shall be made clearly available at the time of manufacture.
How Can One Apply For Medical Device Registration In Australia?
As earlier mentioned, if any manufacturer has to get into the market of medical devices in Australia, then one needs to obtain the registration certificate, issued by the Australian Register of Therapeutic Goods (ARTG), governed by the Therapeutic Goods Administration. It becomes much easier if one already has the European CE marking, as Australia gives identification to the CE Marking. Let’s take a look at the registration process:
- The first step is the categorization of classification using Schedule 2 that comes under the Australian Therapeutic Goods (Medical Devices) Regulation 2002. At the time of registration, Therapeutic Goods Administration (TGA) accepts a European CE Marking, attested by a Notarial Body. In case your device has earned the CE Marking the classification is likely to be the same. In case you do not have a CE marking, then you must take a TGA Conformity Assessment, in order to obtain a CE Marking Certification. Therapeutic Goods Administration (TGA) also sanctions devices having certification of Medical Device Single Audit Program (MDSAP). This program certification permits to conduct a single regulatory audit of the medical devices, also determine the Manufacturer’s total quality management whether it complies with all the regulatory jurisdiction.
- Secondly, in case of absence of any local representative in Australia, the applicant can appoint an Australian TGA sponsor who shall act as a go-between the Manufacturer and the TGA regulatory authority. The Australian Sponsor shall expedite the process and will be accountable for the medical device registration and post-market surveillance. He shall also report about the contingent events that may arise in future to the regulatory authority (TGA). The Sponsor’s name and details must be mentioned on the device and product label.
- The applicant must keep all the Technical files updated and also comply with the Australian Declaration of Conformity at the time of submission. Declaration of Conformity, as a part of the registration process, states the Manufacturer shall submit an affirmation to the TGA which clearly states that the medical device has complied with all the directive necessary principles.
- The Sponsor has to submit all the certification the Manufacturer has obtained as an evidence (e.g. CE Marking Certificate, MDSAP Certificate) to the TGA Authority for their approval and confirmation, applicable for all the devices except Class 1 Non-sterile and non-measuring medical devices.
- The sponsor then submits a medical device application in the TBS system which includes Intended Purpose Statement, Classification and Global medical device name code along with all the specifications and accordingly the application fees is to be paid to the regulatory authority by the Manufacturer.
- Technical documentation for the Class 3 devices will be reviewed by the Therapeutic Goods Administration (TGA), which is a part of level 2 application audit. It is necessary for every medical device company to maintain all its technical specifications up to date which is subject to audit by the concerned authority or Notified Bodies.
- Subsequently, the regulatory authority (TGA) will approve or reject the application upon its examination. In case the application is approved by TGA, an Australian Register of Therapeutic Goods Listing number will be issued against the medical device and the listing will be published in the ARTG database on the TGA website.
- To conclude, you can start to market your medical device in Australia. The validity of your registration will continue to remain until you do not make any changes to the device that nullify your ARTG listing. Also the Manufacturer needs to pay the annual ARTG listing fee.
Fees Structure and Timeline for Medical Device Registration in Australia
It is required to pay a one-time listing fee for a medical device to be registered on the ARTG along with the annual fees for its renewal of the ARTG Registration, though the fees are updated every financial year. The time frame of the process for Medical Device Registration in Australia and its approval depend upon the documentation provided by the Manufacturer which is measured in terms of quality, absoluteness, authenticity and its preparation towards production of any further records on request.
To sum up, it is notable that the companies have already started to capture the medical device market in Australia. Moreover with the recognition of CE Marking in Australia by the concerned TGA authority, registration of medical devices has become much easier than earlier. In fact, it is observed that most of the Global companies who are seeking to acquire the medical device market in Australia already have obtained the CE marking certificate. Before anyone starts to supply medical devices in Australia, It is necessary for the Manufacturer to register the device with the Australian Register of Therapeutic Goods (ARTG), governed by the Therapeutic Goods Administration (TGA).