Dec 2, 2010
There are modifications to TGA medical device applications, TGA's public regulatory consultation, and IVD guidance.
Three additional questions that have been added to the medical device application for inclusions. These questions are designed to give applicants the opportunity to notify relevant Health Technology Assessment (HTA) authorities of their intent to apply for HTA reimbursement.
The questions are as follows:
In the future when Emergo, acting as Australian Sponsor, submits an application for ARTG listing we will address these questions with our clients.
On November 2, 2010, the TGA released a discussion paper, Reforms in the Medical Devices Regulatory Framework, for public comment on proposed reforms of the Australian regulatory system based on recommendations from the HTA Review.
The HTA Report was released (Feb 27) with recommendations for reforms to the current system designed to improve health care for Australian population, reduce regulatory burdens on industry, and allow timely access to emerging technologies. The TGA proposed changes are designed to comply with the HTA Review recommendations.
Among several important proposed changes that would affect the medical device industry are:
Anyone wishing to participate in the future direction of the Australian Regulatory system is encouraged to submit their input. The public comment period will end December 17, 2010. Instructions for submitting comments by mail or email can be found on the TGA website at: https://www.tga.gov.au/consultation/reforms-medical-devices-regulatory-framework
With IVD regulations now fully implemented, the TGA has rolled out their first guidance documents. These will be valuable resources for manufacturers to determine conformance requirements. The documents can be accessed through the TGA website at: https://www.tga.gov.au/ivd-guidance-documents
The TGA has published public comments to the discussion paper, Reforms in the Medical Devices Reg
The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010. The changes will be implemented on 1 July 2010, and serve to amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes to TGA legislation pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs); the likely implications of which are described below.
The Therapeutic Goods Administration (TGA), Australia’s medical device and pharmaceutical regulator, has set up easier online access to its