We offer consulting services for Medical Device Registration TGA Australia to clients wishing to register medical devices with the Australian TGA, for sale within Australia.
Products classified as medical devices cover a very broad range, from bandages to surgically implanted devices such as pacemakers. The TGA classifies medical devices according to the risk posed by the device to the patient. Accordingly, the TGA requires different processes and levels of information as evidence that the safety, quality and performance of a medical device are adequate, in the process is known as conformity assessment.
PharmOut can help with classification of your medical device, what information is required and when. We can support many types of medical devices: from active and non-active devices, including sterile and electro-medical products, to in vitro diagnostics as well as drug-device combinations and borderline products.
Our Consultants can advise on:
- Medical Device product classification
- Preparation of technical files
- Risk assessment
- Quality audits
- CE Marking
- ISO 13485:2016, US FDA QSR 820 and related standards.
We can provide advice across the life-cycle of your medical device from product development, preclinical and clinical research to market, including scientific advice, quality assurance and regulatory affairs.
R&D programs for novel products
PharmOut can assist with planning R&D programmes for novel products. This includes designing suitable studies to meet regulatory requirements and achieving timely approvals in target countries. Our auditors can undertake cGMP, QSR, ISO 9000, ISO 13485 audits of companies, their suppliers and subcontractors, ensuring that appropriate standards of quality are met for your novel products.
CE Marking of medical devices
Medical device registration in the European Union is now harmonised with four European Directives in force, products bearing the CE mark can be freely marketed in all EU member states. CE marking is an important milestone in getting your product ready to market.
In Vitro Devices (IVD)
The Australian TGA regulates in vitro devices as a subset of medical devices. Their regulatory framework aligns with the recommendations of the (old)Global Harmonisation Task Force (GHTF), which now forms the foundation of the International Medical Device Regulators Forum (IMDRF). More information on IVDs