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Australian Medical Device Conformity Assessment Regulations updated by the TGA

Posted by:
October 12, 2021
in: Medical Technology Regulation, News, TGA


In July 2021 the Therapeutic Goods Administration (TGA) published significant updates to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

Access the current version of the Regulations via the TGA website.

WHAT HAS BEEN UPDATED?

Sub-regulation 4.1

This sub-regulation has been repealed.

So what does this mean? It is no longer a requirement for the manufacturer of medical devices which fall into the categories listed below, to hold a TGA Conformity Assessment (CA) certificate as the only accepted evidence of conformity, before submitting your application for inclusion on the Australian Register of Therapeutic Goods (ARTG).

  • Medical devices, other than IVD medical devices, that contain tissues of animal origin that have been rendered non-viable (other than those that are intended to come into contact with intact skin only);
  • medical devices, other than IVD medical devices, that contain tissues, cells or substances of microbial or recombinant origin and are intended for use in or on the human body;
  • medical devices, other than IVD medical devices, incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;
  • medical devices, other than IVD medical devices, that incorporate, or are intended to 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;
  • Class 4 IVD medical devices;
  • Class 4 in-house IVD medical devices (other than those to which the conformity assessment procedures set out in Part 6B of Schedule 3 are applied).

Sub-regulation 5.3

This sub-regulation details medical devices which have been subject to audit as part of the ARTG inclusion process. The list has been extracted from the Regulations and is provided below.

  • A medical device (other than a condom) that is a barrier indicated for contraception or prevention of the transmission of disease in the course of penile penetration during sexual intercourse.
  • A medical device that is an implantable contraceptive device.
  • A medical device of a kind described in subclause 5.3(2) of Schedule 2; Note: Subclause 5.3(2) of Schedule 2 applies to a medical device that is specifically intended by the manufacturer to be used for disinfecting another medical device.
  • A Class AIMD medical device.
  • A medical device that is an implantable intra-ocular lens.
  • A medical device that is an intra-ocular visco-elastic fluid.
  • A Class III medical device that has not been assessed under the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement.
  • Any of the following IVD medical devices:
    • Non assay-specific quality control material that is intended for monitoring a Class 4 IVD medical device;
    • an IVD medical device that is intended for self-testing;
    • an IVD medical device that is intended for point of care testing;
    • a Class 3 IVD medical device that is intended for detecting the presence of, or exposure to, a sexually transmitted agent;
    • an IVD medical device for managing or monitoring the treatment of infections diagnosed using a Class 4 IVD medical device (for example, quantitative nucleic acid test (NAT) and genotyping assays for HIV and HCV);
    • an IVD medical device that is intended to be supplied for use under the pharmaceutical benefits scheme;
    • an IVD medical device that is intended to be supplied for use in a national screening program;
    • if the Secretary is not satisfied that a body or authority has the authority and expertise to exercise a power or perform a function of the Secretary mentioned in sub-regulation 3.5(1)—an IVD medical device that has been manufactured in a location and at a site where that body or authority has exercised such a power or performed such a function in relation to the device;
    • a Class 4 IVD medical device;
    • a Class 4 in-house IVD medical device;
    • an IVD companion diagnostic.

So what has changed? A new item (2AA) has been added to this sub-regulation which removes the requirement for devices listed above to undergo mandatory audit by the TGA prior to ARTG inclusion. To be eligible, manufacturers of the devices listed above must hold current conformity assessment certificate issued by a Notified Body under the European Medical Device (MDR) Regulations 2017/745 or In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It should be noted that expired, suspended and revoked certificates will not be accepted.

WHAT DO THESE UPDATES MEAN?

The updates made to the legislation will ease the regulatory burden for certain manufacturers that previously required TGA CA as the only evidence of conformity in addition to speeding up the ARTG inclusion process for certain devices that were previously subject to mandatory audit. It is worth noting that these changes only apply to CE Marked devices under the MDR (EU) 2017/745 and the IVDR (EU) 2017/746 and does not change the requirement to ensure all necessary evidence to demonstrate conformity is maintained.


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