Currently, the TGA is the only Notified Body in Australia that can issue Conformity Assessments (CA). There has been significant movement with respect to CA for Australian medical device manufacturers. It is expected that in 2015 the TGA will accept conformity assessments from 3rd party Notified Bodies.  

If you require further information regarding this significant change or a CA quotation, 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/Sterilization/ISO 9001)

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

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

•        Quotations for ISO transfer of certificate

•        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