Australia’s TGA Medical Device Reform to reclassify certain medical devices
TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union.
Australia’s TGA GMP inspections during COVID-19
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
Australia’s TGA regulations for cosmetics with sunscreens
In Australia, cosmetics that contain sunscreens (UV filters) are regulated by the Health Authority Therapeutic Goods Administration (TGA). The cosmetic can only be approved for market if it meets the legal definition of either ‘therapeutic’ or ‘cosmetic’.
TGA’s expectation on hosting remote inspection during COVID-19 pandemic
Therapeutic Goods Administration (TGA) publishes the Good Manufacturing Practices (GMP) approach for oversees manufacturers to assist manufacturers who may undergo remote inspection.
TGA announces new fee schedule and delays in proposed regulations
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July1, 2020.
Social Media Advertising in Australia
Therapeutic Goods Administration (TGA) oversees advertisement of goods in Australia and has set forth the requirements of advertising
Australia’s TGA lifts pre-approval for medicinal advertisements in “specified media”
As of 1 July 2020, medicine advertisements in specified media will no longer need pre-approval from Australia’s (TGA)
Fecal Microbiota Transplant Products guidelines published by TGA
TGA released new guidelines on fecal microbiota transplant (FMT) products which states how FMT products would be classified and regulated.