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Our local team are your experts in Medical Device Registrations for Australia

Welcome to RQSolutions

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RQSolutions is a team of strategic professionals with over 35 years in Product Registrations and Quality Management in the Health Care Industry.

We are well known at both a local and global level with involvements with a number of companies ranging from the startup company to multinational manufacturing facilities in Europe, US and the Asia Pacific region.

Our forte is our continual training on updated regulatory requirements, our deliberations in various committees in association with our collaborating partners for a globalised and harmonized registration framework and the implementation of best practice excellence in Quality System maintenance.

We work closely with the Therapeutic Goods Administration (commonly referred to as the TGA), the Australian government regulatory health authority, responsible for therapeutic goods clearance for our client companies intending to supply therapeutic products – Medical Devices

Products approved for supply to the Australian Healthcare market include orthopaedic implants, pacemakers, ophthalmic, surgical equipment and a myriad of other medical devices with a risk classification of I to class III and AIMD).

We are continuously looking at partnership with other associations in our effort to jointly provide excellence in the services we provide.

We also represent OBELIS. S.A. in Australia for companies who are looking for EC representation and product registrations in the European market. Click here to visit our page at OBELIS. S. A. Click here to visit the OBELIS. S. A. page on the Australian and the European Regulatory Environment for Medical Devices

Should you require to contact them, Please email Obelis on mail@obelis.net or call RQSolutions directly on +61 2 9882 2030 and ask for George Azoury.

Need help?

Call RQSolutions for assistance on
+61 413 578 665

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Testimonials
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US Medical Device manufacturers supporting Australia’s growing Health Care needs.

I was most privileged to be invited at a recent reception, hosted in April 2017, by the U.S. Consul General Mrs Fowler, in Double Bay,...

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Critical changes restricting the importation of Medical Devicesto Australia from 1 December 2016.

Medical Devices must be registered with the Australian Health Authority, the Therapeutic Goods Administration (TGA) before they are authorised for supply in the market. Respective...

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The significance of the Australian Declaration of Conformity for Medical Devices

Introduction The Australian Declaration of Conformity (DoC) for medical devices is a required document by both the Therapeutic Goods Administration (TGA)and the Australian Communications and...

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European Union (EU) Essential Requirements Checklist and the Australian Principles Checklist for Medical Devices-Significance in a technical file and differences

Introduction The Australian Essential Principles Checklist (AEPC) is a list of 15 general and specific rules set by the Therapeutic and Good Administration (TGA). These,...

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