Published: 8 January 2014
Consultations
Standards for Contraceptive Devices supplied in New Zealand - Summary of Consultation
About Medsafe
Introduction
Reason for Consultation
Submissions
Next Steps
About Medsafe
- Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is responsible for the regulation of therapeutic products in New Zealand through administration of the Medicines Act 1981.
- Medsafe is a business unit of the New Zealand Ministry of Health.
- Medsafe’s Mission is: 'To enhance the health of New Zealanders by regulating medicines and medical devices to maximise safety and benefit.'
- In working to achieve the stated mission Medsafe:
- applies accepted international practice to the regulation of therapeutic products
- provides efficient services measured against agreed stated performance indicators
- prepares and maintains regulatory guidelines reflecting sound science and promoting evidence based decisions
- applies processes that are consistent, transparent and minimise the costs of regulatory action
- provides timely and unbiased information to health professionals and consumers about the safe use of therapeutic products.
Introduction
From 4 September to 27 September 2013 the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) consulted about proposed changes to the Standards for contraceptive devices currently gazetted by the Minister of Health. Thirty five stakeholder organisations were identified by Medsafe and contacted directly. Additionally the consultation was published to the Medsafe website for public view. (www.medsafe.govt.nz/consultations/ContraceptiveDevices.asp) Seven submissions were received by Medsafe. These submissions have been reviewed by Medsafe and 17 comments were identified as relevant to the consultation.
This document summarises the main themes identified from these submissions and outlines Medsafe’s responses. Medsafe thanks everyone who provided a submission for their valuable contribution to this project.
Reason for 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 Gazette by the Minister of Health.
Only devices complying with the current gazetted Standards may be supplied in New Zealand.
The changes being consulted on were proposed for the following reasons;
- to update older Standards to the latest versions
- to recognise international Standards for contraceptives for which there were no previous Standards, and
- to recognise international Standards for contraceptives manufactured from materials not covered by current Standards
Current Standards
At the time of the consultation the following Standards were gazetted.
| Standard Ref | Standard Name |
|---|---|
| ISO 4074:2002e Corrigenda 1: 2003 | Natural Latex Rubber Condoms; Requirements and Test Methods |
| NZS 7106:1998 | Polyurethane Condoms |
| NZS 7102:1980 | Specifications for Intra-Uterine Contraceptive Devices |
| BS 4028:1966 with amendments | Specification for Reusable Contraceptive Diaphragms |
Proposed New and Changed Standards
Medsafe proposed to recommend to the Minister of Health the following changes be made to the gazetted Standards.
It was proposed to REPLACE the following Standard:
| Standard to be replaced | New Standard |
|---|---|
| BS 4028:1966 with amendments | ISO 8009:2004 - Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms, requirements and tests |
It was proposed to ADD the following Standards:
| New Standard |
|---|
| ISO 23409:2011 - Male Condoms - Requirements and test methods for condoms made from synthetic materials |
| ISO 25841:2011 - Female Condoms - Requirements and test methods |
| ISO 7439:2011 - Copper-bearing contraceptive intrauterine devices - Requirements and tests |
Note that ISO 7439:2011 only applies to copper-bearing IUDs. This would
be in addition to NZS 7102:1980 which would remain applicable to both copper
bearing and non-copper bearing IUDs.
Submissions
Medsafe received submissions on all of the proposed Standards as well as on some of the currently gazetted Standards.
Two submissions were also received in relation to the approval process for copper intrauterine devices (IUDs) which are categorised as medicines under the Medicines Act 1981. These submissions were outside of the scope of the consultation, however, the comments have been noted.
ISO 4074:2002 – Natural Latex Rubber Condoms, requirements and test methods
Two submissions were received in relation to this currently gazetted Standard. Both submissions noted that an update to the Standard (“Technical Corrigendum 2”) was issued in 2008 but not mentioned as part of this consultation.
Medsafe notes Technical Corrigendum 2 was published by the International Standards Organisation on 15 April 2008. The document deletes the requirement for testing of oven treated condoms to check for major formulation or vulcanisation errors. As the Technical Corrigendum does not change any of the fundamental requirements and tests for latex condoms it has not been proposed to gazette this amendment. A revised edition of ISO 4074 will be consulted on once it is published.
ISO 8009:2004 – Mechanical contraceptives, reusable rubber and silicone rubber contraceptive diaphragms, requirements and tests
Two submissions were received in relation to the proposed replacement of the current gazetted Standard (BS 4028:1966 with amendments) with this Standard. Both submissions were supportive of the adoption of the ISO 8009:2004 Standard.
ISO 23409:2011 – Male Condoms, requirements and test methods for condoms made from synthetic material
Medsafe received four submissions on the proposed adoption of this Standard. All submissions were supportive of the adoption of the ISO 23409:2011 Standard.
One submission was also received relating to the potential for ISO 23409:2011 to replace the currently gazetted Standard NZS 7106:1998 Polyurethane Condoms.
Medsafe notes this submission and will consider this as part of a future consultation on contraceptive devices.
ISO 25841:2011 – Female condoms, requirements and test methods
Medsafe received five submissions on the proposed adoption of this Standard. All submissions were supportive of the adoption of the ISO 25841:2011 Standard.
ISO 7439:2011 – Copper bearing contraceptive intrauterine devices, requirements and tests
Medsafe received four submissions relating to this Standard. Two of the four submissions were supportive of the adoption of the ISO 7439:2011 Standard. Two of the submissions were not within the scope of the consultation as they commented on the use of the Standard in relation to applications for approval as medicines.
Other comments
Medsafe received two submissions relating to the consultation process and the need for organisations to purchase copies of the Standards in order to respond on the technical requirements of the Standards.
Medsafe appreciates the difficulties; however, Standards documents are the subject of copyright and the use of ISO publications is subject to acceptance of ISO's terms of use and conditions, as set out below.
'All ISO publications and national adoptions thereof are protected by copyright. Therefore and unless otherwise specified, no part of an ISO publication or a national adoption thereof may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, microfilm, scanning, without permission in writing from the publisher'.
Next Steps
Medsafe has reviewed the submissions received in response to this consultation. As the overall response from stakeholders was in support of the proposal Medsafe will recommend adopting the proposed change to the Minister of Health.
Until these proposed Standards are gazetted only devices complying with the current Standards may be legally supplied in New Zealand.
If the Minister of Health accepts the recommendation proposed regarding these Standards, this decision will be confirmed in the New Zealand Gazette and on the Medsafe website.
