No Medical Devices can be supplied in Australia unless they are TGA approved. RQSolutions will review your regulatory files and will work with you to ensure that your product meets the Essential Principles Checklist and that all associated requirements are met before the application is lodged for TGA assessment.
Our expertise and involvement in the Medical Devices industry since the introduction of regulations is your assurance that your product will be approved in readiness for your launch dates. We specialise is Risk and Clinical Data Assessments and Standard Procedure write-ups.
Our involvement with a myriad of companies manufacturing various current and new technologies, will give you that confidence that you are with the right professionals in the industry. Refer to testimonials in this website for a small number of our clients.
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.