TGA Updates Uniform Recall Procedure
27th Oct 17
The Therapeutic Goods Administration (TGA) has published a revised Uniform Recall Procedure for Therapeutic Goods (URPTG) that should be used by dental product suppliers needing to undertake a recall.
Key Issues For The Dental Industry —
The TGA Uniform Recall Procedure for Therapeutic Goods provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia. It has been updated following a period of public consultation, with the last edition having been published in 2014.
The purpose is to assist sponsors in conducting recalls and non-recall actions using a standardised systemic procedure. It enables sponsors to respond efficiently and effectively to issues with a therapeutic good that has or may pose a risk to public health and safety.
This procedure is also applicable when the TGA orders an appropriate responsible entity to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall. Further information on the URPTG can be downloaded from the link below:
The publication is particularly relevant to dental product manufacturers and suppliers as, under the Therapeutic Goods Act 1989 (Cth), a product recall is taken to protect the health and safety of consumers from therapeutic goods that are, or may be, affected by an issue with a therapeutic good in relation to its safety, efficacy, performance, presentation, or quality. The process applies equally to businesses that have entries on the Australian Register of Therapeutic Goods (ARTG), the list of medical devices that can be lawfully supplied in Australia, in addition to custom-made medical devices (e.g. dental laboratory products) where there is no requirement to place the products on the ARTG.
To product public health and safety, it is important that any recall or non-recall action is undertaken by the sponsor responsible for therapeutic goods, follows the recall procedure, and involves all relevant stakeholders.
Member engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to matters associated with dental product the team in the ADIA national office receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee with updates provided to members at the quarterly series of ADIA State Branch Briefings.
Currency & Disclaimer —
This update was issued on 27 October 2017 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
2nd Jul 18
Importers of dental laboratory products are being encouraged to review Australia’s regulatory standards to ensure their suppliers are aware of the design and construction principles that protect patient safety.
25th Jan 18
For the dental industry, and medical devices sector more broadly, the TPP Free Trade Agreement will improve the information available to importers and exporters and reduce unnecessary delays in approvals, improving standard-setting.