Published: 11 April 2024


Outcome of the consultation on standards for contraceptive devices in New Zealand

About the consultation
Submissions received


  • Medsafe sought comments on updating the gazetted standards applicable to four groups of contraceptive devices.
  • Medsafe received 11 responses to the consultation.
  • Download the consultation outcome document to view the consultation feedback:
    Standards for contraceptive devices in New Zealand – Consultation outcome (PDF, xx KB, 9 pages)
  • Medsafe will recommend that the updated standards be gazetted.
  • These standards will take effect from the date of the gazette notice, and contraceptive devices supplied in New Zealand from that date will be required to meet the new standard.

About the consultation

Contraceptive devices supplied in New Zealand, as required under section 6 of the Contraception, Sterilisation and Abortion Act 1977, must comply with standards as published in the New Zealand Gazette by the Minister of Health.

The last change to the gazetted standards for these devices was in 2014. Since that time, four of the five ISO standards gazetted at that time have been updated, one of the NZ standards that was gazetted has been removed by Standards New Zealand. This consultation proposed replacing some older standards with the latest versions of these standards – as shown in Table 1.

Table 1: Contraceptive device standards under consultation

Standard to be replaced Standard name New standard
ISO 4074:2002e / Corrigenda 1:2003 Natural Latex Rubber Condoms, Requirements and test methods ISO 4074:2015
ISO 25841:2011 Female Condoms – Requirements and test methods ISO 25841:2017
ISO 8009:2004 Mechanical contraceptives – Reusable natural and silicone rubber contraceptive diaphragms, requirements and tests ISO 8009:2014
ISO 7439:2011 Copper-bearing contraceptive intrauterine devices – Requirements and tests ISO 7439:2015

The New Zealand Standard, NZS 7102:1980 Specifications for Intra-Uterine Contraceptive Devices, was withdrawn by Standards New Zealand in 2014. The consultation feedback identified that no contraceptive devices are currently being supplied that meet this withdrawn standard.

The consultation opened on 17 March 2020 and closed on 14 May 2020.

Submissions received

There were 11 responses to the consultation. Respondents included importers, health care professionals, members of the public, manufacturers, sponsors (suppliers), industry organisations and a community health organisation.

Medsafe would like to thank all those who took the time to respond to the consultation and provide comments.

To view a summary of the submissions, please download the Consultation outcome document.


After consideration of the consultation feedback, Medsafe has decided that the updated standards should be recommended for gazettal.

Medsafe will arrange for the four new standards to be gazetted.


The new standards will be effective from the date of the gazette notice. Any new product imported or introduced to the market must comply with the new standard.


For any enquiries about this consultation, please email and put Contraceptive Standards in the subject line of your email.

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