If your product meets the Private Health Insurance (Prostheses) Rules then it qualifies to be government reimbursed and approved for inclusion in the Prosthesis List . The application to the Prosthesis List Advisory Committee requires particular and specific inputs.
RQSolutions involvement in a number of different technologies inclusive of implantable orthopaedic (knees, shoulders, acetabular liners, screws etc), cardiovascular (stents, pacemakers, shunts etc) , neuromuscular stimulation systems etc will give you that assurance of unquestionable expertise.
We know our requirements and we will work with you and our contacts at the department to ensure your product is listed in the next PLAC publication.
In the event, your product does not have an associated Professional Service number and considered a new technology that let us assist you with required applications to the Medical Services Advisory Committee (MSAC).
RQSolutions has been servicing the global Therapeutic Goods Industry for over 35 years’ expertise, in Australian Sponsorship, TGA Registrations and Licences, Reimbursement of Medical Devices, Quality Management Systems and auditing, Complaints Handling and Compliance, Regulatory Intelligence, EU Representation, Cosmetics assessments and Approval,Training, Document Management, Distributor Appointments.
We are based in Sydney and a heartbeat away from our colleagues at the TGA. Unlike others with only a virtual office in Australia, we will get back to you with prompt responses whenever received.
Let us share with you, the various available options on Medical Devices in Australia. We are only a phone call away to discuss your Registration and Compliance needs.