• 2022-01-26 08:15:53

TGA has already implemented reforms to the regulation of software-based medical devices from 25 February 2021. Under the new regulation, some software may be excluded from the TGA regulations, or although still regulated by TGA they may be exempted from the need to include the product in the ARTG. In the following, we gathered some FAQs and have summarised TGA’s article to help you have an insight on what is required to operate legally in Australia.

• 2022-01-26 04:00:20

Despite it being a criminal offense to import, supply or export medical devices that do not meet the EPSP, there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time. TGA Australia grants exemption in certain situations. Here we gather some FAQs related to the application of the consent for non-compliance of the medical devices and summarize this article in order to help you understand what you need to know for the condition and application.

• 2021-11-24 10:36:48

2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, Thailand, Vietnam and Philippines.

• 2021-11-24 10:22:35

2021 saw some new regulations being introduced by the TGA, especially on reclassified medical devices, software and increased effort on safe post market vigilance. Let’s take a look at what awaits the Australia medical device regulatory landscape in 2022.