Australian Manufacturers

flow-chart-aust-manufacturer1-300x225Medical device regulations allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European Notified Bodies. This means most Australian manufacturers can now choose to have their conformity assessment conducted by the TGA or a European Notified Body.

KD&A, as an expert medical device and IVD consultant, has 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

KD&A can help you understand what you need to do, when you need to do it and how much it will cost. 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

KD&A specialises in building and maintaining Quality Management Systems based on ISO 13485 and medical device regulations. A KD&A Quality Management System is designed specifically for your organisation and country specific requirements. Having a Quality Management System is an essential medical device requirement that assist in demonstrating regulatory compliance and product conformity.

Build Technical Documentation

Also known as a Technical File or Design Dossier. KD&A has extensive experience in developing medical device regulatory compliant Technical documentation. A KD&A Technical File is developed in conjunction with your organisation, in line with internationally acknowledged Standard Technical Documentation (STED) Guidelines and describes the performance and safety requirements of your device. This is a key component of gaining regulatory certification.

Lodge a TGA or CE Marking Conformity Assessment and Product Certification

KD&A can assist you to successfully work through the TGA or CE Marking Conformity Assessment process including the examination of technical documentation and quality management system audits. KD&A provides critical initial and ongoing support. KD&A’s guidance through the medical device certification process ensures you achieve and maintain device certification.

Lodge an application for ARTG inclusion – Australia only

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. KD&A’s vast experience with medical device applications will save you time and money so that you can begin to supply the medical device on the Australian market.

Prior to supplying your medical device on the Australian market, KD&A recommends the following additional service.

Promotional Materials Review

Ensure your medical device’s promotional materials (including labelling and packaging) comply with the Therapeutic Goods Advertising Code.