The sponsor is responsible for applying to the TGA to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG). In Australia, therapeutic goods must be included on the ARTG before they can be sold. The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.
RGN Medical is a registered entity based in Adelaide, South Australia and fulfils all the necessary requirements to qualify as a sponsor for overseas medical device manufacturers
Employees are the biggest asset for any organization. Keeping the skill and knowledge at optimal levels is essential to maintain an edge in the industry. With rapidly evolving regulatory requirements and new industry standards, it is often challenging to keep up with the requirements.
RGN Medical provide a wide range of services to meet the individual organization needs. From providing pre regulatory audit supports to QMS system development, we are always with you on this journey. With years of experience in regulatory industry (Pharmaceutical and Medical Devices) we endeavour to bring the best and most efficient Quality Management System to you.
RGN medical aspire to the trusted business partner by acting as a “Sponsor” for overseas manufacturers to liaise with the Therapeutic Goods Administration (TGA) on all matters relating to the provision of Medical Devices in Australia and ensure product registration with ATGR. We understand the confidentiality of commercial operation and act with integrity and ethics while handling sensitive information. RGN has robust procedures in place to ensure data security both in electronic and physical form.
With years of industrial experience, we have gained extensive knowledge in global regulatory requirements across a range of device classifications for CE Marking (European Union), Food and Drug Administration (FDA, United States), Health Canada and TGA (Australia). With hands-on experience across the entire medical device life cycle including design and development, risk management, manufacturing support and post market surveillance our practical industry experience provides clients with regulatory solutions focused on compliance while meeting individual commercially focused needs.
To maintain control over device and IVD registration, it is generally recommended for overseas manufacturers to appoint a "third party" Sponsor who is not commercially involved in the sale of the products and acts solely as regulatory representative in Australia. RGN medical not only provide Sponsorship services at the most competitive price, but it also provides you with necessary regulatory intelligence to make informed commercial decisions.