11609 (2025). Benjamin Doyle to the Associate Minister of Health
Written Question
Published date: 01 Apr 2025
11609 (2025). Benjamin Doyle to the Associate Minister of Health: On what date, if at all, did the Minister or their Officials provide the Ministry of Regulation with a Regulatory Impact Analysis (RIA) regarding the regulation of POCT (STI self-test kits)?
Hon Casey Costello: Ministry of Health officials provided a draft RIA on medical device regulation to the Ministry of Regulation on 12 August 2024, and a final version was provided on 16 September 2024. This RIA included a discussion of Point of Care Tests such as STI self-test kits.
The RIA is publicly available on the Ministry of Regulation website: https://www.regulation.govt.nz/our-work/regulatory-impact-statements/regulatory-impact-statement-product-and-activity-controls-for-medical-devices/