The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsibly responsible for establishing and setting regulatory guidelines for medical device regulation.
The TGA regulates and monitors therapeutic goods through various processes by:
- Authorizing the commercial supply of therapeutic goods for use in Australia through the Australian Register of Therapeutic Goods (ARTG), an electronic register of therapeutic goods that can be lawfully supplied in Australia.
- Monitor the safety of therapeutic goods using information from various sources, including the community, healthcare providers, overseas regulators, and the ARTG entry holders (‘sponsors’) and manufacturers as a part of their reporting obligations.
- Certify Australian and International manufacturers to ensure products made in are of an appropriate standard.
The medical device regulation set out the requirements for the different classes of medical devices depending on devices intended use. In Australia the medical device classification are as follows:
- Class 1;
- Class 1 Sterile or Class 1 with a measuring function;
- Class11a
- Class11b
- Class 111
- AIMD
Class 1 medical devices are the lowest level of medical device classification and the successively higher level as Class 111 or AIMD
The Principles for applying the classification rules to a medical device is having regard to the devices intended use.
- If a medical device is designed to be used in combination with another medical device, each of the devices is classified separately.
- An accessory to a medical device is classified separately from the medical device.
- If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device.
- If a medical device is not designed to be used solely or principally in a specific part of a patient’s body, the medical device is classified as having regard to the most critical specified use of the medical device.
- If based on the intended purpose of the device, 2 or more classification rules apply to the medical device, the device has the highest level of classification applying under the applicable classification rules.
- The classification level of the system or procedure pack is that of the highest class of device components supplied in the system or procedure pack.
The approach to regulation for therapeutic goods depends on the level of risk to public health and/or safety of the product. When a product is in a higher risk category a more rigorous assessment level is applied to the manufacturers data or technical information, which is required especially to demonstrate quality, safety, efficacy, and performance, set out in the medical device regulation. If a product meets all regulation requirements approval is given and the medical device is included in the ARTG.
For a company to market a medical device in Australia, the Australian Sponsor must ensure that the manufacturer of the medical device holds appropriate documentation for the Class of medical device being supplied. This process often involves collaboration with medical equipment suppliers to ensure compliance with all regulatory standards.
The manufacturer of the device is responsible for a number of actions mentioned below:
- For each medical device, determine and assign the:
medical device classification,
intended purpose
appropriate GMDN code
- Select and apply appropriate conformity assessment procedures to demonstrate compliance with the Essential Principles
- Have their Quality Management Systems (QMS) certified, by an approved TGA organisation (European Notified Body or international Regulator -MDSAP regulator) which demonstrates that appropriate Conformity Assessment Procedures have been applied to the product’s manufacture.
- Prepare an Australian Declaration of Conformity that includes all the manufacturing details for the medical devices
- Ensure that their conformity assessment procedures are appropriately maintained once they obtain the necessary conformity assessment evidence and that the ongoing requirements are met (for example, reporting adverse events, regular quality systems audits)
The manufacturer should have the following documents available for the Australian Sponsor :
- Complete and current Medical device File or a Technical File (STED format)
- Clinical Evaluation Report and data
- Risk Analysis and Risk management report
- Copy current QMS Certification
- Australian Manufacturers Declaration of Conformity
The Australian Sponsor must:
- Apply to the TGA to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG). In Australia, therapeutic goods must be included on the ARTG before they can be sold.
- Must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.
- Have an eBS account Client registration issued by the TGA
- Have procedures in place, including a written agreement with the manufacturer, to obtain information from the manufacturer when requested by the TGA
- Ensure that:
– they have available sufficient information to substantiate compliance with the Essential Principles or have procedures in place to ensure that such information can be provided from the manufacturer to the TGA within 20 working days
– an appropriate conformity assessment procedure has been applied to the medical devices
– the manufacturer has appropriate conformity assessment evidence for the medical device
– the conformity assessment evidence remains valid while the device is supplied in Australia
- For devices other than Class I not supplied sterile or with a measuring function, submit the conformity assessment evidence to the TGA
- Apply to include the medical devices in the ARTG, including certifying that the information provided is complete and correct
- Have their sponsor label applied to the device’s packaging
- Arrange for fees to be paid for applying to include the medical device in the ARTG registration
- Upon request:
provide documentation relating to the medical device to the TGA
– deliver samples of the medical device to the TGA
– allow a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located
- Notify the TGA of certain incidents and performance issues
- Ensure the information about the device complies with the regulatory requirements
Related Post: What you should look for a TGA sponsor
The Next Steps
Depending on the Classification of the device the electronic application contains a number of nested questions applicable to a specific classification. Information regarding the GMDN code, UPI, and intended use should be available at the time the application is being drafted.
Class 1Sterile to Class 11b medical devices
- Register if required the manufacturers details with the TGA
- Submit manufacturers QMS certification for approval via the TGA eBS lodgement portal
- Lodge submission application for the device inclusion on the ARTG.
- Have a Medical device file and other manufacturers documents available for submission if requested.
- Pay the application fee.
- Once the application is received and approved, the medical device is assigned an ARTG inclusion number and is now included on the ARTG
- The medical device can now be sold in Australia.
Class I, Non-Sterile, Non-Measuring Medical Devices or Export Only devices
- Register if required the manufacturers details with the TGA
- Lodge Class 1 or Export Only device application via the TGA eBS lodgement portal
- Have available if requested manufacturers documentation if available
- Pay the application fee.
- Class 1 and export only devices are not subject to any pre-market assessment, therefore the application is approved, assigned an ARTG inclusion number and is now included on the ARTG
- The medical device can now be sold in Australia.
Class III or AIMD Medical Devices
- Register if required the manufacturers details with the TGA
- Submit manufacturers QMS certification for approval via the TGA eBS lodgement portal
- Lodge submission application for the device inclusion on the ARTG.
- Have a Medical device file and other manufacturers documents available for submission.
- Pay the application fee.
- Pay assessment evaluation fee
- Provide additional documentation for assessment evaluation when requested
- Once the application is received and approved, the medical device is assigned an ARTG inclusion number and is now included on the ARTG
- The medical device can now be sold in Australia
Some medical device manufacturers, must have a TGA Conformity Assessment Certificate and therefore will need to be inspected by the TGA, regardless of whether they have a certificate issued by an EU Notified Body. These manufacturers are:
- Any manufacturer who manufactures medical devices containing:
– Materials derived from animals that have been rendered non-viable—there are some exceptions to this requirement
– materials of microbial or recombinant origin
– stable human blood or plasma derivatives
– medicinal substances (substances that if used separately would be considered medicines)
What’s Next?
Once a medical device’s application is approved by the Therapeutic Goods of Australia, its inclusion will remain valid, provided there are no regulatory actions imposed that will result in the cancellation of the inclusion.
Contact our Medical Equipment Suppliers Consultant to help you with your device regulatory needs.