As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia).
Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies – what the Australian medical device industry has been pushing for for quite some time now has finally come to fruition.

This means that Australian MD manufacturers will no longer require TGA Conformity Assessment to manufacture and sell medical devices here in Australia; European EC Certificates will now be accepted (class dependant).

For more information on this regulatory change contact Compliance Management Solutions.

About CMS:

Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA/MDD | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:

Ø Australian ARTG registration/sponsorship/consultancy (medical devices/medicinal products)
Ø Implementation and maintenance of Management Systems (MDD/ISO 13485/Sterilization/ISO 9001)
Ø Management Systems audits – (MDD/ISO 13485/Sterilization/ISO 9001)
Ø 3rd Party Notified Body Certification Audits (MDD/ISO 13485/ISO 9001/ISO 22716)
Ø Quotations for ISO transfer of certificate
Ø Risk Management
Ø Continuous improvement including Corrective/Preventive Action
Ø Validation including (Process/Equipment Qualification/Sterilization)
Ø Machinery/Equipment commissioning/installation and troubleshooting
Ø Complaint handling
Ø Process Improvement using Lean Six Sigma methodologies
Ø Web based compliance management software

Compliance Management Solutions
Melbourne, Australia

E: [email protected] | M: 0433 12 42 66
W: www.compliancems.com.au