Medical Device Compliance: 9 Critical Steps
In compliance terms, the term ‘medical device’ includes a wide range of products, for example: medical gloves, bandages, syringes, blood pressure monitors, and x-ray equipment. To sell medical devices in Australia, both the device and the seller must meet stringent TGA requirements (Therapeutic Goods Administration is the government body responsible for regulating the safety, quality, and effectiveness of medical devices). The following steps outline what’s involved in becoming compliant.
1. Determine the regulatory classification
Medical devices are classified into four classes (Class I, IIa, IIb, and III) based on their risk level. The higher the potential risks of a device, the more it needs to be examined and monitored, so each class has different requirements for assessment and registration.
2. Appoint an Australian Sponsor
If the manufacturer is overseas, an Australian sponsor must be appointed who will act as a local representative. The sponsor is legally responsible for the device. The sponsor can be a person or a company but must be resident in Australia.
3. The sponsor must establish an e-business account with TGA
4. Register with the Australian Register of Therapeutic Goods (ARTG)
Medical devices must be registered on the ARTG before they can be legally supplied in Australia. The process involves submitting detailed information about the device, its intended use, manufacturing processes, and evidence of its safety and performance.
5. Compliance with Essential Principles
There are six general principles that every device must comply with and a further nine principles which can be applied, depending on the type of device. Even after a device has been approved, manufacturers must monitor ongoing performance to ensure the device continues to comply with these principles.
6. Labelling and Instructions for Use
Every medical device must be appropriately labelled according to TGA requirements. The labelling should include essential information about the device, its intended use, and instructions for use.
7. Obtain an Australian Business Number
If you plan to sell medical devices in Australia, you will need to have an Australian Business Number (ABN) to conduct business legally.
8. Customs and Importation
If devices are shipped from overseas, the manufacturer must ensure compliance with importation regulations and where necessary, work with border authorities to clear the goods through customs.
9. Post-Market Responsibilities
Once a medical device is on the market, the manufacturer is responsible for reporting adverse events, monitoring product safety, and complying with any post-market surveillance requirements.
No medical device is completely safe and without risks and side effects. The purpose of the TGA regulation is to minimise the potential risks as much as possible. To be certain of TGA compliance, it might be advisable to seek professional help with registering medical devices in Australia.
This communication (including any attachment) has been prepared by BWES and is based on the available information at the time of publication and is believed to be true and accurate. The information contained in this communication should be used as a guide only and may cease to apply if applicable regulation or the product’s design or application is altered. BWES does not take responsibility for any Injury, Loss for damage suffered by any party’s interpretation or decisions made by any party on the information provided in this communication.