As an Australian medical device or IVD manufacturer, you are required by Australian regulator, the Therapeutic Goods Administration (TGA), to obtain certification of your products and to maintain compliance with TGA requirements.
KD&A have many years of experience with the TGA. We work closely with our clients to assist them from the early product development phase to build the required regulatory documentation and a Quality Management System. We take a pragmatic approach to regulatory compliance and create strategies aligned with the realities of business.
Recommended Route to Regulatory Certification
Develop a Regulatory Strategy
A KD&A Regulatory Strategy will enable your organisation to identify the regulatory requirements for your medical device in desired markets and plan accordingly for the future.
Develop and Implement a Quality Management System
A KD&A Quality Management System is designed specifically for your organisation, and will be based on ISO 13485 and country specific requirements. A Quality Management System is essential in demonstrating regulatory compliance and product conformity.
Build Technical Documentation
Also known as a Technical File or Design Dossier. Technical documentation by KD&A shall be developed in conjunction with your organisation, in line with internationally acknowledged Standard Technical Documentation (STED) Guidelines.
Lodge a TGA Conformity Assessment Application
This application is the next step in obtaining TGA certification. KD&A has significant experience with this process and can provide guidance and support to your organisation.
Lodge an application for ARTG inclusion
The TGA requires all medical devices sold in Australia are included on the ARTG. To obtain inclusion on the ARTG your organisation must complete a process which is dependent on device type and classification. Once an ARTG inclusion is obtained, you can begin to supply the medical device on the Australian market.
Identify distributors and lodge applications for other desired markets based on your organisation’s Regulatory Strategy (see Regulatory Strategy above).
Note: This process does not apply to IVD manufacturers . For information on the IVD requirements contact KD&A.
Prior to supplying your medical device on the Australian market, KD&A recommends the following additional service.
Ensure your medical device’s promotional materials (including labelling and packaging) comply with the Therapeutic Goods Advertising Code.