How to apply for a conformity assessment certificate and/or an EC Certificate of Conformity under the EU-Australia MRA
Australian medical devices guidelines
Guidance document number 26
A Conformity Assessment Certificate is a certificate some manufacturers need to obtain from the TGA before a medical device can be included in the Australian Register of Therapeutic Goods (ARTG). Conformity Assessment Certificates are issued to manufacturers, not to sponsors.
This document outlines how to apply for a conformity assessment certificate and/or an EC certificate of conformity under the EU-Australia MRA.
Contents
- What is a conformity assessment certificate
- Section A - for manufacturers who are not EC certified by a EU notified body
- Section B - for manufacturers who are EC certified by a EU notified body
- Section C - for all manufacturers of devices containing materials of animal, microbial or recombinant origin
- Section D - for all manufacturers of devices containing medicinal substances
- Section E - for Australian/New Zealand manufacturers applying for an EC certificate of conformity under the EU-Australia mutual recognition agreement
- Section F - other certificates for medical device manufacturers
- How to apply for a certificate
- What happens next
- How can I get further information about the application process if this document does not answer my questions
- Form to be supplied with the supporting information