The Australian medical device regulations allow manufacturers to obtain Australian Register of Therapeutic Goods (ARTG) Inclusion/Australian TGA certification for most medical devices using certifications such a CE Marking Certification, Pre-Market Certificate (Japan), Register Entry (Singapore) and MDSAP with the applicable product assessment evidence (510(k), De Novo request or Medical Device License (Canada).
KD&A, as an expert medical device consultant has 30 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 QMS, Technical File documentation and medical device applications. 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 is your roadmap to market.
Develop and implement a Quality Management System
KD&A specialises in ISO 13485 QMS development, maintenance, internal auditing and support including regulator/ Notified Body audits. A KD&A QMS is designed specifically for your organisation and country specific requirements. Maintaining a QMS is an essential medical device requirement to ensure 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 File 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, QMS, 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 registration 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.