Medical Device Manufacturers

The medical device regulations allow manufacturers to obtain Australian Register of Therapeutic Goods (ARTG) Inclusion/Australian TGA certification for most medical devices using certifications such as CE marking, MDSAP, etc.

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 Technical File documentation and Quality Management System. We take a pragmatic approach to regulatory compliance and create strategies aligned with the realities of business.


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 is your roadmap to market.

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 File Documentation

Also known as a Technical File or Design Dossier. KD&A has extensive experience in developing medical device regulatory compliant Technical File. A KD&A Technical File is developed in conjunction with your organisation, in line with internationally acknowledged Standards Guidelines and regulatory requirements. The Technical Documentation 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 support with development of the Technical File, Quality Management System, audits and ongoing support. KD&A’s guidance through the medical device certification process supports you in achieving and maintaining device certification.

Lodge an application for ARTG inclusion – Australia only

The TGA requires all medical devices sold in Australia to be 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 medical devices in Australia.

Prior to supplying medical devices in Australia, 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.