Web16 feb 2024 · PI documents can be found by searching this website or by using the PI search database in eBusiness Services (for industry). You can enter the product name, … WebAbout the ARTG. The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia. The search is regularly used for various personal, research and business …

Standards, guidelines & publications (medical devices & IVDs)

WebIf your enquiry is not about TGA Business Services, see: Contact the TGA. Email. [email protected]. Phone. 1800 010 624 (freecall within Australia) +61 2 6232 8888. Users who are deaf or have a hearing or speech impairment can call through the National Relay Service: TTY or computer with modem users: phone 1800 555 677 then ask for … WebThe Australian Sponsor is responsible for device registration (ARTG listing) and post-market activities, such as adverse incident reporting and recalls. The Australia Sponsor’s name and contact information must appear on the device and device label. Emergo can provide Australia Sponsor services from our office in Sydney. citywise cars

Including IVD medical devices in the ARTG Therapeutic Goods ...

WebThe ARTG is the public database of therapeutic goods that can be legally supplied in Australia. You can search the ARTG to find details of therapeutic goods approved for … WebApplications for new generic and biosimilar medicines are excluded from this list. The entry for each application includes: the proposed tradename. the applicant name. the active ingredient (s) a summary of the proposed indication (s) the application type. Publication commenced for applications accepted for evaluation from January 2024. WebTherapeutic Goods Administration (TGA) We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. We regulate medicines, medical devices and biologicals to help Australians stay healthy and safe. city wisconsin