• 2024-06-20 06:31:57

Australia is advancing in 3D-printed medical devices, demonstrating the technology's potential in healthcare. The market, valued at $36 million in 2022, is projected to reach $132 million by 2030, driven by applications in pre-operative planning, education, orthodontics, bioprinting, and customized prosthetics and implants. These innovations enhance patient outcomes and surgical accuracy, with significant growth expected in the Asia-Pacific region.

• 2024-06-20 06:13:07

The TGA's new "Examples of Boundary and Combination Products" clarifies how to classify complex goods that blur the lines between medicines, medical devices, and biologicals. This list includes common products like injectable fillers and contact lens solutions.

• 2024-06-27 05:11:25

This article provides a comprehensive guide on TGA sponsors, a critical partner for medical device companies seeking to enter the Australian market. It explains the role of the Therapeutic Goods Administration (TGA) and how a TGA sponsor acts as a liaison, navigating the complex regulatory process to ensure compliance.

• 2024-05-08 03:23:54

The TGA is streamlining therapeutic goods recalls with phase two of its Recall Reforms. This initiative aims to achieve a dual benefit: reducing the regulatory burden on sponsors and strengthening public safety.

Sponsors will experience a simplified and more flexible reporting process, while the "Early Advice" program, allowing proactive communication with the TGA, will see enhanced communication protocols.

• 2024-05-08 03:10:55

To promote consistent advertising practices across the medical industry, the TGA updated its guidelines for promoting cosmetic injectables.

• 2023-10-20 08:57:40

The TGA is launching an initiative known as the Medical Devices Vigilance Program (MDVP). This program will kick off with a 12-month pilot phase, strategically crafted to assist medical device sponsors in adhering to regulations and assuring the Australian public that sponsors are fulfilling their obligations.

• 2023-08-23 06:20:33

The Australian government has extended medical device reform deadlines due to the EU MDR transition, enabling manufacturers to obtain EU MDR certificates and sponsors to engage with the TGA under the new regulations until July 1, 2029. This adjustment aligns with the EU MDR transition's conclusion on December 31, 2028.

• 2023-07-21 03:49:06

The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.

• 2023-06-28 09:52:24

The Therapeutic Goods Administration (TGA) created a plan to help Australian medical device sponsors and stakeholders transition to the new EU Medical Device Regulation (MDR). The EU then extended the transition period, so the TGA reviewed its original plan. An updated strategy guideline has been published by the TGA regarding the transition and reclassification of certain medical devices.

• 2023-05-24 07:30:46

To mitigate the risk of nanomaterials, the amendment has been made by the Therapeutic Goods Administration (TGA) to the existing Essential Principle 7 to include the additional obligations. The amended Essential Principles checklist can be viewed and downloaded from TGA’s website.