On September, 15th 2021, the Australian Therapeutic Goods Administration (TGA) published on their website the updated table with an essential principles list for Medical Devices.
The table consists of a useful list which ensures Medical Devices Manufactures to demonstrate their products’ compliance to these essential principles.
What are the essential principles?
The document published by TGA includes a full list of essential principles split in two main sections:
- General principles.
- Principles about design and construction.
General principles focus on security and efficiency of Medical Devices authorised to be placed on the Australian market.
Principles about design and construction, on the other hand, describe the aspects concerning the Medical Device and its component’s design, including those connected with its production and composition.
Inside this section, at point n° 15, there are some principles applying to In-Vitro Diagnostic Medical Devices (IVDs) only.
In this case as well, the Manufacturer has to satisfy a series of principles, such as:
- Using suitable materials for Medical Devices;
- Guaranteeing Medical Device safety when used with drugs or substances;
- Adopting measures sufficient enough to minimize the risk of unwanted radiation exposure;
- Evaluating and limiting risk associated to factors like noise, vibrations, and other mechanic risk to which the Medical Device could be exposed;
- Providing the necessary information to identify the Medical Device and its Manufacturer;
- Providing the instructions for use which both patients and health workers using the Medical Device need to consider.
What do Manufactures need to do?
It’s important that the updated version of this TGA document is considered by Manufacturers who want to market their Medical Devices in Australia to demonstrate their compliance to security and efficiency requirements.
Thanks to strategic – regulatory consulting services, Sponsor services, and Medical Devices and IVDs registration in Australia, Thema experts can help you to deal with these new requirements and can give you support if you intend to market your devices in Australia.
Feel free to contact us if you need technical support: email@example.com