5 de setembro de 2019

TGA NEWS: Proposed clarification of the regulatory requirements for medical device systems and procedure packs

From: www.tga.gov.au

The Australian government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian government, Department of Health, the TGA regulates these products, and is responsible for implementing the government reforms.

In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) made 58 recommendations for reform of the regulatory framework for medicines and medical devices in Australia. The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released in September 2016. The Government accepted 56 MMDR recommendations including Recommendation Twenty[1] which addressed matters within the remit of the TGA. This Recommendation provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework.

The focus of this consultation, which follows on from an external workshop in Feb 2019, is on the proposed reforms to the regulation of systems or procedure packs and the impact of these reforms. The changes proposed in this consultation are intended to facilitate better regulatory compliance and consequently improve safety and quality of medical devices used in system or procedure packs, and will wherever possible align with the EU Framework.

Interested parties should respond by close of business Thursday, 17 October 2019.

How to participate?

Complete the online consultation submission form to upload your submission in either pdf or word format.

Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:

Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100