07/22/2019 | News release | Distributed by Public on 07/21/2019 21:09
This webinar will provide an introduction to the difference in regulatory oversight for a Class I and Class IIa medical device. This is important if you are the manufacturer or sponsor of a medical device that changes from Class I to Class IIa. This might happen because new features are added to the product or because of regulatory reform. This webinar is intended for stakeholders who are unfamiliar with the Australian framework for regulating medical devices.
Who should attend?
Software developers, manufacturers and sponsors that are unfamiliar with the difference in requirements between Class I and Class II medical devices.
Medical devices are classified according to their potential to cause patient harm, except for Software as a Medical Device (SaMD). Under the current regulations, the majority of SaMD products are classified as Class I, regardless of the potential for harm. As part of its reform to the regulation of software, including SaMD, the TGA has proposed to bring classification of SaMD in line with other medical devices. This proposal has been generally supported by stakeholders. However, it is likely to mean that some SaMD products change from being Class I products, which are self-certified, to Class IIa, which require third party oversight.
Developers, manufactures and sponsors who are new to the medical device sector, or who only produce Class I products may not be familiar with what the regulatory requirements will be if their product changes from Class I to Class IIa.
How do I register?