February 9th – 13th 2026

Inform Items

1. MTAA responded to a review on the national messaging  ‘Why conduct a clinical trial in Australia’ of the relevant webpage on the Australian Clinical Trials website, you can find our comments in the attached document.
2. The TGA is progressing administrative amendments to relocate the power for Authorised Persons to enter and inspect clinical trial sites under the CTN and CTA pathways from the Therapeutic Goods Regulations 1990 into the Therapeutic Goods Act 1989. This change will not affect the operation of the GCP Inspection Program, which has been in place since 2022, and no additional consultation is planned. Existing powers under Section 46 of the Act remain in effect, so there will be no interruption to inspections. There is also no impact on implementation of ICH E6(R3), and the transition period from 13 January 2026 to 13 January 2027 remains unchanged. Members are to contact JB or LAW with any questions.
3. Virtual participation is available for Days 1 and 2 of the IMDRF meeting in Singapore, 9 to 13 March 2026, those interested in attending virtually can contact the organisers directly at: contactus@imdrf2026.com.sg.

Action Items

1. The DR AS/NZS 3551:2026 Management programs for medical equipment standard is open for commenting, you are invited to review and submit public comments for the draft of the same (attached), via this link, open until March 12th.
2. We are inviting nominations to MTAA’s 2026 Clinical Investigations Forum (CIF), please reach out to LAW or JB if you or someone in your organisation would like to be involved.
3. Marcelle will be attending the first QAF meeting in-person in April, please reach out if you would like to be included in the group this year.
4. There are four open consultations:

i) Conformity Assessment Procedures – we’ve created a short-term working group to formulate our response, given the significant impact to our members. Please reach out to LAW if you would like to be involved, the first meeting is on Wednesday Feb18 from 10 – 11am.

ii) Improved sharing of information about medical devices

iii) Targeted consultation on improved information sharing (attached)

iv) TGA Fees and Charges – feedback on TGA’s proposed fees and charges for 2026-27. Here is the MTAA Response form link , open for response until COB Feb20.

We are having a meeting on Monday Feb16 between 12 – 1pm to discuss our response to both ii) and iii). Please reach out to LAW if you would like to be involved.