TGA 2020- 2021 Fiscal Year Fee Schedule:
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July 1, 2020. The schedule includes an increase of 1.95% from the previous year.
An important update to the fee schedule is a discount of 50% to the annual Australian Register of Therapeutic Goods (ARTG) Prostheses listing for Fiscal year due to the COVID pandemic. Medical Device manufacturers need not submit a request for the discount, it automatically applies to the eligible entries.
Proposed Regulation Delays:
Another announcement from the TGA, is the delay in the proposed rule for a number of medical device regulatory forums. The TGA announces a delay in the implementation of the reforms from August 25, 2020 to:
- November 25, 2021 for reclassification of certain devices
- February 25, 2021 for software as a medical device (SaMD)
- February 25, 2021 for personalized medical devices (including 3D-printed devices)
- November 25, 2021 for systems or procedure packs
- May 26, 2023 Medical Device Regulations
- May 26, 2025 In-Vitro Diagnostics
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at email@example.com