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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
Version 1.0, November 2011
Manufacturers are invited and encouraged to meet with the TGA prior to submitting their application for a TGA Conformity Assessment Certificate. A meeting will assist to:
- ensure that the applicant understands the conformity assessment process
- introduce the devices to the TGA so that issues are considered before the application is lodged and documentation can be provided with the application to address any concerns.
Pre-submission meetings may be face-to-face or via teleconference.
Meetings provide a valuable opportunity to discuss any anticipated difficulties, which should assist in a timely completion of the assessment. However, please be aware that at the time of the meeting, the TGA cannot guarantee the acceptability of the application or anticipate the outcome of the assessment. To arrange a meeting an email can be sent to firstname.lastname@example.org.
Applicants requesting a pre-submission meeting should be prepared to provide:
- a presentation on a novel, or newly developed device, its use and design, or a list of the devices to be covered by the application
- a summary of the testing done and evidence held, including clinical evidence
- an outline of the dossier(s) to be presented (for a Class 4 IVD or Class 4 in-house IVD) or the technical files for lower classification devices
- proposed conformity assessment route(s)
- a summary of readiness for quality management system audit of the manufacturer and/or description of other regulatory QMS certification for the manufacturer
- an expected date of submission of an application.
There are no fees for a pre-submission meeting.