Australia’s Therapeutic Goods Administration is proposing changes to its low-value turnover exemption scheme that could help some devicemakers save money while reducing red tape and making the process more user-friendly and transparent.

The government levies annual charges to recover the costs of certain regulatory functions for medical devices and other products listed on the Australian Register of Therapeutic Goods.

The current scheme allows firms to avoid those charges if their annual sales turnover is less than or equal to 15 times the fee. Because of the burden involved in preparing and submitting an application, some companies are discouraged from seeking the exemption, the TGA says.

Under the revised scheme, the exemption would be replaced by an annual charge exemption, or ACE. Devicemakers could self-declare that they had zero dollars of sales turnover in the previous fiscal year to qualify for the exemption, rather than having to obtain a third-party accountant’s certification. The government would conduct audits to detect incorrect declarations.

The new scheme would simplify the exemption process for devicemakers and the TGA by eliminating applications and application fees and not requiring approval by a delegate of the health secretary, the TGA says.

The Federal Executive Council is expected to consider the proposal before June 30, says TGA spokesman Neil Branch. Once approved, the agency will provide guidance to industry.

Starting next month, the TGA plans to inform devicemakers of eligibility for an initial ACE, with plans to implement the scheme on July 1. Sponsors would be required to self-declare on an annual basis between July 1 and July 22 starting next year. Annual charges would be due Sept. 15.

Read the regulation impact statement and Q&A document at www.fdanews.com/5-15-TGA-ACE.pdf and www.fdanews.com/5-15-TGA-ACE-QA.pdf, respectively. — Jonathon Shacat