SERVICES
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A summary of services is provided below.
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AUSTRALIANÂ TGA REGISTRATION
All medical devices supplied in Australia must be registered with the Australian Therapeutic Goods Administration (TGA).
In this context, registered means included on the Australian Register of Therapeutic Goods (ARTG).
To be included on the ARTG medical devices must meet the requirements of the Australian medical devices regulations, including compliance with the Australian Essential Principles for safety and effectiveness.
MDA can manage all steps in the TGA registration process, from Sponsor registration to product applications and TGA liaison.
AUSTRALIAN SPONSOR (DISTRIBUTOR)Â RESPONSIBILITIES
The Australian Sponsor is the company responsible for the registration of a medical device with the TGA. They have a number of legal responsibilities associated with TGA registration.
The Sponsor must ensure:
• Any manufacturer’s certification used to support a TGA registration application remains valid.
• Procedures are in place, including a written agreement with the manufacturer, to ensure documentation to substantiate compliance with the Essential Principles, and in some cases product samples, are available and provided to the TGA on their request.
• Distribution records for devices supplied in or exported from Australia are maintained.
• All product complaints are assessed, and adverse events and performance issues are reported to the TGA.
• Any overseas regulatory actions related to devices are reported to the TGA.
• Implementation of any field corrective action (recall, notices to customers) is reported to and coordinated with the TGA.
• Any advertising is compliant with the Therapeutic Goods Advertising Code.
• When applicable, annual reports are submitted to the TGA.
MDA provides guidance and assistance to Sponsor’s with all their legal obligations.
REIMBURSEMENT (PROSTHESES LISTING)
Medical devices included on the Prostheses List are eligible for reimbursement by private health insurance companies, thus minimising patient out-of-pocket expenses. The Prostheses List is administered by the Prostheses List Advisory Committee (PLAC) in the Australian Department of Health and Ageing.
While the Therapeutic Goods Administration (TGA) assesses medical devices for clinical effectiveness and safety, the PLAC determines whether devices should be included on the Prostheses List and sets the level of reimbursement (benefit).
Medical devices that are eligible for inclusion on the Prostheses List include many types of implantable devices such as hip replacements, intraocular lenses, spinal implants, and cardiac implantable pacemakers. Some non-implantable medical devices, such as ablation catheters, insulin infusion pumps and cardiac home/remote monitoring systems, are also eligible for listing. Devices such as external limb prosthetics, external breast prostheses, or implants used solely for cosmetic purposes are not eligible for inclusion.
Applications for inclusion on the Prostheses List are made via the Prostheses List Management System (PLMS) website portal.
MDA can manage all steps in the reimbursement application process.
MEDICAL DEVICE MANUFACTURERS
MDA can assist medical device manufacturers with:
• Regulatory planning
• Submission preparation and writing
• Design control
• Risk management
• Training in regulatory in requirements