Pre-submission meetings for medical device conformity assessment
Section 41EA of the Therapeutic Goods Act 1989 (the Act) requires that certain manufacturers and certain devices must undergo conformity assessment by the TGA before an application can be made to include the devices in the Australian Register of Therapeutic Goods.
The Therapeutic Goods (Medical Devices) Regulations 2002 specify that in accordance with section 41EA of the Act that a conformity assessment certificate issued by the TGA is required for medical devices which
- contain tissues of animal origin that have been rendered non-viable (other than those intended to come into contact with intact skin only), or
- contain tissues, cells or substances of microbial or recombinant origin intended for use in or on the human body, or
- incorporate stable derivatives of human blood and human plasma that are likely to act on the human body in a way that is ancillary to the device, or
- incorporate as an integral part, a substance that if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device.
Australian manufacturers are also required to hold a conformity assessment certificate issued by the TGA for all devices manufactured and supplied in Australia (except for Class I devices).
Applicants for a conformity assessment certificate issued by the TGA are invited and encouraged to meet with the assessment staff within the devices program prior to submission of an application for a conformity assessment certificate. A meeting serves the purposes of
- ensuring that the applicant understands the process and the time-frames for the conformity assessment process, and
- introducing the device(s) to the TGA so that issues which may arise during the assessment are considered and may be addressed in the documentation accompanying the application.
It is the TGA's experience that such meetings provide a valuable opportunity to forestall problems with an assessment and facilitate timely completion. The meetings also provide a forum for the applicant to discuss expected difficulties and for both parties to agree on an acceptable approach to resolution. However, at the time of the meeting, the TGA cannot guarantee the acceptability of the application or anticipate the outcome of the assessment.
Applicants requesting a pre-submission meeting should be prepared to provide
- a demonstration or presentation on the device, it's use and design, with a sample if appropriate and possible;
- a summary of the testing done and evidence held, including clinical evidence;
- an outline of the dossier to be presented (for a Class III or AIMD device) or the technical file for a lower class device;
- a summary of readiness for quality management system audit of the manufacturer and/or description of other regulatory QMS certification for the manufacturer; and
- expected date of application.
Should you wish to arrange a pre-submission meeting for your application, please contact Ms Shelley Tang <mailto:shelley.tang@tga.gov.au> on 02 6232 8793 or Mr Rod Ferrari <mailto:rodolfo.ferrari@tga.gov.au> on 02 6232 8706.