The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.
More In the beginning of 2022, the Therapeutic Goods Advertising Code 2021 came into effect. Six month transition period were given, and sponsors and manufacturer were allowed to either follow the 2018 Code or the 2021 Code until 30th June 2022. From 1 July 2022 onwards the option of complying with the 2018 Code yet no longer applies.
More The TGA has given a presentation about the evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims in the Australasian Society for Biomaterials and Tissue Engineering (ASBTE) Conference 2022. This presentation provided manufacturers and sponsors general insights on the subject of medical devices with anti-viral or anti-microbial claims before the device inclusion in the Australian Register of Therapeutic Goods (ARTG).
More Recently, software technology has made significant advances and has been used considerably more frequently for medical purposes. It can drive itself to infer a clinical judgment in addition to serving as a message informant. The number of software-based medical devices that are currently on the market has significantly increased as a result of such software improvements. Therefore, it is important to monitor patient safety appropriately.
More In December 2018, TGA has announced that there will be an adjustment of Surgical Mesh Devices to transform from medium risk (Class IIb) to high-risk devices (Class III), in order to meet the highest levels of safety, quality and clinical performance.
Sponsors were given three years to comply with the changes, and from 1 December 2021 onwards TGA has already commenced on cancelling surgical mesh devices in the ARTG as Class IIb entries, who do not have obtained an appropriate conformity assessment certificate for Class III devices prior to the set deadline, or within six months of the conformity assessment certificate for the Class III device being issued.
TGA has listed out 3 different tables, categorising meshes that are eligible for transition, approved surgical mesh devices, and existing Class III surgical mesh devices. This is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1st December 2021, and to provide alternative sources of supply.
As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.
More Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.
More 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.
More 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.
More TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.
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