Before someone can supply a medical device for sale in Australia they are required to make an application to include the device/system in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. Please note that all accessories to medical device systems (eg defibrillator pads, tubing, filters, masks etc) must also be registered in the ARTG if sold individually.
The application process can be exhaustive as this is dependant upon the classification of the device. Once a product has been approved for supply, the obligations of sponsors continue. The device must continue to meet regulatory, safety and performance requirements (Post Market Surveillance).
Compliance Management Solutions can assist in device registration and post-market surveillance.
If you require further information regarding the Australian Medical Device Regulations, please do not hesitate to contact Compliance Management Solutions.
About CMS:
Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | 13485 (Medical Devices) | 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/ 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 transfer of ISO certificates
• 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