Recently, the European Union has issued a new version of the Medical Device Regulation (MDR), aimed at improving the safety and quality of medical devices, ensuring their reliability and effectiveness. Company news FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regu...
Once a product is approved, the agency continues to monitor it through various vigilance activities. This means manufacturers should pursue postmarket quality management and continuous improvement. Learn More Pursue TGA compliance with confidence. Guide your company to successful compliance with TGA ...
After submission, the TGA reviews the documentation to assess whether the device meets Australian safety, quality, and performance standards. If the device is approved, it is included in the Australian Register of Therapeutic Goods (ARTG), and the manufacturer can legally market the...
It is also alleged that advertising on the VeraTemp Pty Ltd website for non-contact infrared thermometers falsely suggested that the thermometers had been approved by the TGA, when no such approval has been given. Advertisers must not make any statement that implies goods have been recommended or...
TGA RELEASED REGULATION IMPACT STATEMENT (RIS) EXPOSURE DRAFT OUTLINING PROPOSED TIGHTER CONTROLS FOR CONFORMITY ASSESSMENTBased on the TGA assessment, the proposed reforms fulfill the objectives of the RIS. It will help ensurethat high risk medical devices approved do notcompromise public health and ...
https://www.tga.gov.au/covid-19-rapid-antigen-self-tests-are-approved-australia#home-use 3. 不是所有的新冠检测试剂盒都能家用 ARTG中注册的许多新冠快速抗原测试并不提供用于家庭自测。这些新冠检测试剂用于即时检测,可由卫生从业人员或在其监督下经过培训的工作人员在实验室环境之外使用。相关检测试剂盒的信...
European Union and Canada for medical devices); products which are not approved in Australia but approved in countries other than those with regulatory standards comparable to that in Australia; products which are currently under evaluation within TGA; products that are not approved anywhere and are ...
medical practitioner as an Authorised Prescriber 19 Conditions may be imposed on the endorsement by an ethics committee 19 An ethics committee can withdraw its endorsement 20 Circumstances under which TGA may revoke an Authorisation 20 How to obtain an unapproved medicine or medical device once ...
UK. The approved indication in Europe is the same as the proposed indication in this application. A similar application has been lodged in the USA (June 2006) and Canada (November 2007). The status in these countries is pending. Product Information ...
may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia. Report counterfeit medicines and medical devices If you are worried aboutcounterfeit medicines or medical devices, and want to report an issue, you can report the matter to the...