Australian Medical Device Registration / Sponsorship

As you may be aware, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia.

If you are an overseas manufacturer of medical devices and you require Australian registration, let Compliance Management Solutions act as your sponsor.

About CMS: 

Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include: 

•        Australian ARTG registration/sponsorship/consultancy (medical devices/medicinal products)

•        Implementation and maintenance of Management Systems (TGA/MDD/ISO 13485/Sterilization/ISO 9001)

•        Management Systems audits – (TGA/MDD/ISO 13485/Sterilization/ISO 9001)

•        3rd Party Notified Body Certication Audits (MDD/ISO 13485/ISO 9001/ISO 22716)

•        Quotations for ISO re-certification

•        Risk Management

•        Continuous improvement including Corrective/Preventive Action

•        Validation including (Process/Equipment Qualification/Sterilization)

•        Machinery/Equipment commissioning/installation and troubleshooting

•        Complaint handling

•        Process Improvement using Lean Six Sigma methodologies

•        Web based compliance management software 

Thank you and regards, 

George Loizou
Compliance Management Solutions
 

E:  [email protected] | M: +61 4 3312 4266
W:
https://compliancems.com.au