Since antiquity, medical devices have been used to treat and diagnose disease. Nowadays, they are widely used in all branches of medicine, surgery, and community care. Medical device classification ranges from adhesive bandages that would be put on a scratch to high-risk products like pacemakers, a type of implantable medical device in Australia, that help control abnormal heart rhythms. To enable access high quality, safe, and effective medical devices, it is important to have these devices comply with Australia medical device regulations. The regulation ensures public health benefit and safety of the whole community.
Australia, like any other country, has a certain institution that oversees medical devices, and it is the Therapeutic Goods Administration or TGA. The Australian medical devices guidelines are outlined in the Australian Regulatory Guidelines for Medical Devices (ARGMD) by the TGA. Here are the steps you need to take for TGA medical device registration in the country.
Before proceeding to the process of getting approval for a medical device, you must first properly determine its classification, corresponding to its level of risk to the human body. Class 1 devices, the lowest risk medical devices, are not assessed by the regulatory body prior to inclusion on the ARTG registration. If the device fits into more than one classification, its proper classification is one with the highest level of risk. The following categories make up the Therapeutic Goods Administration’s medical device classification system:
- Class I – elastic bandages, tongue depressors, cervical collar, slings, non-sterile dressings
- Class IIa – X-ray films, contact lenses, catheters, intravenous tubing
- Class IIb – condoms, blood bags, dressings for severe wounds
- Class III – intrauterine contraceptive devices, coronary artery probes, medical devices that contain medicines, such as dressings with an antimicrobial agent
- Class AIMD (Active Implantable Medical Devices) – pacemakers, cochlear implants
Note that the first step towards getting your medical device in the Australian market is determining its proper medical device classification according to its risk.
Step #1: Identify the proper medical device classification
Before proceeding to the process of getting approval for a medical device, you must first properly determine its classification, corresponding to its level of risk to the human body. Class 1 devices, the lowest risk medical devices, are not assessed by the regulatory body prior to inclusion on the ARTG registration. If the device fits into more than one classification, its proper classification is one with the highest level of risk. The following categories make up the Therapeutic Goods Administration’s medical device classification system:
- Class I – elastic bandages, tongue depressors, cervical collar, slings, non-sterile dressings
- Class IIa – X-ray films, contact lenses, catheters, intravenous tubing
- Class IIb – condoms, blood bags, dressings for severe wounds
- Class III – intrauterine contraceptive devices, coronary artery probes, medical devices that contain medicines, such as dressings with an antimicrobial agent
- Class AIMD (Active Implantable Medical Devices) – pacemakers, cochlear implants
Note that the first step towards getting your medical device in the Australian market is determining its proper medical device classification according to its risk.
Step #2: Appoint an Australian TGA Sponsor
If you don’t have a physical presence in Australia, look for and secure an Australian TGA Sponsor. The sponsor must be a resident of Australia or an incorporated body and conducting business in Australia where the representative of the company is residing in the country.
The sponsor exports and imports therapeutic goods from and into Australia. He or she manufactures therapeutic goods for supply in Australia or elsewhere and organises for another party to import, export, or manufacture therapeutic goods.
When cooperating with the TGA, the will act on your behalf. He or she is responsible for applying to the TGA to have your medical devices included on the Australian Register of Therapeutic Goods or ARTG. In registering the device, the sponsor acts as the liaison between the manufacturer and the TGA, and his or her name must appear on your device and labeling.
Step #3: Prepare Technical File or Design Dossier
The next step you have to take is to have your current Technical File or Design Dossier ready for submission.
What is a Technical File?
A technical file is a specialised document that speaks to all the information held by a producer in connection to a specific IVD (in vitro diagnostic). The documentation is an output of the manufacturer’s quality administration system, and incorporates data created all through the design, development, production, and monitoring phases of the IVD. The information may be held over various areas or in various structures, and different components from the technical file can be used to conform with the Essential Principles of safety and performance. It must also be produced and maintained for medical devices sold in Australia.
What is a Design Dossier?
Manufacturers of medical devices entering the AUstralia marketplace must have their design dossier examined by a Notified Body. The application should include the device description, device history, essential principles checklist, risk analysis and control summary, design and manufacturing information, clinical evidence report, performance evaluation, product validation and verification, stability, and the information to be supplied with the IVD
Those who manufacture Class IIa and IIb medical devices are not obliged to submit a design dossier for a review to a Notified Body. Manufacturers of Class I medical devices are allowed to carry out their own conformity assessment activities due to the low-risk classification associated with the devices. This basically means that only manufacturers of Class III devices are required to submit a dossier design to a Notified Body.
Step #4: Prepare Declaration of Conformity
Medical manufacturers are required to make a declaration of conformity as it is part of the conformity assessment procedures. The document must declare that the medical device complies with the applicable provisions of the essential principles, the medical device classification rules, and an appropriate conformity assessment procedure.
The declaration must also cover details that are relevant to the conformity assessment procedure such as data about the manufacturer.
Step #5: Obtain CE Marking
For all devices except Class I Non-sterile and non-measuring, you or your sponsor must submit Manufacturer’s Evidence, such as CE Marking Certificate in the Therapeutic Goods Administration Business Services (TBS) system for TGA’s review and acceptance. You can get your CE Marking and ISO 13485 from the Notified Body. In cases when the manufacturer has already a European CE Marking for the device, the process will be much simpler.
Step #6: Let TGA Review Your Design Dossier
As part of a Level 2 application audit, the TGA will review sections of your Design Dossier. Level 2 application auditing is required for all Class III devices and a small percentage of Class IIb devices.
After a careful review of your documents, the TGA will approve or reject your application. If approved, your device will receive ARTG registration. The TGA will then issue an ARTG listing number (ARTG Certificate of Inclusion), which can be viewed in the ARTG database on its website.
Step #7: Place Your Medical Devices in the Market
After complying with all the important requirements and securing an ARTG listing number, you may now begin marketing your device in Australia. Your medical device registration, known as the ARTG registration, does not expire so long as you do not make any changes to your device that would invalidate the ARTG listing, a current CE Marking certificate is on file with the TGA, and the annual ARTG listing fee is paid.
There you have the Australia medical device regulations, that will serve as your map to registering your medical devices in Australia. Take note that this guideline explains the way to compliance in Australia for devices that already have CE Marking and that do not include human blood/plasma derivatives, animal tissues, or medicinal components. A separate guideline for those devices is discussed through the Australian Regulatory Guidelines for Biologicals (ARGB).
If you wish to seek help from a medical device regulatory affairs consultant, Vicki Partridge is the best one to work with. With more than 15 years of working experience in the Therapeutic Goods Administration, your medical device regulatory process will be completely covered. Contact Vicki today and get help with your medical device regulatory needs!
Contact our Medical Compliance Manager to help you with your device regulatory needs.