tga-updates

TGA Updates

TGA Updates: New Pathways, Rule Changes, and Updated Application Requirements

The Therapeutic Goods Administration (TGA) has implemented several changes that will take effect on 1 July 2024. Read on to determine whether any of these TGA updates could impact your products.

Additional Pathway for Medical Devices that are Programmed or can be Programmed/Software as a Medical Device

New classification rules introduced in 2019 have meant that sponsors of devices included in the Australian Register of Therapeutic Goods (ARTG) before 25 February 2021 had until 1 November 2024 to transition to the new classification rules – many of which would be an up-classification.

Given the upcoming deadline and the lack of applications to up-classify, the TGA has allowed an additional pathway to allow sponsors to continue supply of their product after 1 November 2024.

Essential Points

  1. Applying to the TGA to conduct the conformity assessment before 1 November 2024 will allow extension of the deadline.
  2. The application cannot be withdrawn or lapse prior to 1 November 2024.
  3. Application for a new ARTG must be made within 6 months of the date of either:
    • Withdrawal or lapsing of the TGA conformity assessment application.
    • Issuance of the TGA conformity assessment certificate.

Changes to Rule 5.5

Rule 5.5, a classification rule in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002, has been changed to reflect the decreased risk associated with using tissues and or cells of animal origin. Increased vigilance in managing these tissues or cells, particularly following events like mad cow disease, has contributed to this reduced risk. Table 1 shows the rule before and after the amendment. As a result of this change, certain devices, for example, those containing tissues or cells from hair or wool that were previously classified as Class III, may now be classified under a different rule and a lower classification.

Table 1: Changes in Rule 5.5

Before

5.5 Medical devices containing non‑viable animal tissues, cells or other substances, or microbial or recombinant tissues, cells or other substances

(1) This clause applies to a medical device if the device contains:
(a) tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin; or
(b) a combination of tissues, cells or substances of the kind described in paragraph (a).

(2) The device is classified as Class III, unless: (a) the device contains only tissues, cells or substances of animal origin that have been rendered non‑viable; and
(b) the device is intended by the manufacturer to come into contact with intact skin only.

Note: A medical device that conforms with the description in paragraphs (2)(a) and (b) is classified as Class I under clause 2.1 of this Schedule

After

5.5 Medical devices containing non-viable animal tissues, cells or their derivatives

(1) Subject to subclause (2), this clause applies to a medical device if the device contains any of the following:
(a) non-viable tissues, or cells, of animal origin (other than tissues or cells from hair or wool);

(b) derivatives of tissues or cells covered by paragraph (a) (other than sintered hydroxyapatite or tallow derivatives).

(2) This clause does not apply to a medical device if the device is intended by the manufacturer to come into contact with intact skin only.

(3) A device to which this clause applies is classified as Class III.

Main Takeaway

Review your product against the new Rule 5.5 to ascertain whether there is a change in classification.

Changes in Mandatory Auditing of Applications

The TGA has streamlined the applications that must be selected for mandatory audits to focus only on the medical devices that pose the greatest risk of harm to users. Furthermore, they have removed the requirement for a mandatory audit if an approved overseas comparable regulator is used to support the device application. For example, a Class III medical device that has undergone assessment through the Food Drug Administration (FDA) will not require a mandatory application audit.

Changes for medical devices are detailed in Table 2 and Table 3 for IVDs.

Table 2: Medical devices requiring mandatory application audits

Before

  • medical devices (excluding condoms) that acts as a barrier to prevent pregnancy or the spread of disease during sex
  • implantable contraceptive device
  • spinal fusion implantable device
  • products for disinfecting a medical device
  • implantable intra ocular lens
  • medical devices that are an intra ocular visco elastic fluid
  • a Class III medical device (non-EU assessed)

After

  • a Class III medical device
Table 3: IVDs requiring mandatory application audits

Before

  • non assay specific quality control material that is intended for monitoring a Class 4 IVD
  • an IVD for self-testing
  • an IVD for point of care testing
  • a Class 3 IVD that detects a sexually transmitted agent
  • an IVD supplied for use under the pharmaceutical benefits scheme
  • an IVD to be used in a national screening program
  • any other IVD that the TGA is not convinced that a body or authority has the necessary authority and expertise for conformity assessment under subregulation 3.5(1)
  • a Class 4 IVD
  • a Class 4 in-house IVD
  • an IVD companion diagnostic

After

  • a Class 3 IVD
  • a Class 4 IVD
  • a Class 4 in-house IVD
  • an IVD for self-testing
  • an IVD for point of care testing

Key Highlights

Mandatory application audits streamlined and reduced for those who use approved overseas comparable regulators.

Changes to Information Requirements for Applications

Due to the changes in selecting device applications for mandatory audit, the TGA will now require the submission of additional information to support the application. From the 1st of July 2024, Table 4 details the information requirements for each application type.

Table 4: Information Requirements for Application type
Application TypeInformation Required
Class III medical device· Clinical Evaluation Report.
· Instructions for Use
IVD medical device for self testing or point of
care testing
· An assessment of technical documentation referred to in section 5.1 of Annex IX of the EU IVD regulation.
IVD companion diagnosti· An assessment of technical documentation set out in section 5.2 of Annex IX of the EU IVD regulation.
All other Class 3 IVD· An assessment of technical documentation as set out in section 4 of Annex IX of the EU IVD regulation for at least one representative device in a generic device group.

Main Takeaway

Additional information requirements are required to support device applications for Class III medical devices, IVDs for self-testing, point of care testing, companion diagnostics or all other Class 3 IVDs.

How can PharmOut Help?

PharmOut can help you with Medical Device Registration with the TGA in Australia, providing regulatory compliance services for medical device product classification, preparation of technical files, and troubleshooting compliance problems.

References

Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024, Effective date: 14th June 2024, https://www.legislation.gov.au/F2024L00686/asmade/versions, accessed 28th June 2024.

Explanatory Statement to Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024, Effective date: 14th June 2024, https://www.legislation.gov.au/F2024L00686/asmade/versions, accessed 28th June 2024.

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2024, Effective date: 24th June 2024, https://www.legislation.gov.au/F2024L00760/asmade/versions, accessed 28th June 2024.

Explanatory Statement to Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2024, Effective date: 24th June 2024, https://www.legislation.gov.au/F2024L00760/asmade/versions, accessed 28th June 2024.