Revised: 1 July 2014
Medical Devices
Contraceptive Devices
Contraceptive devices must comply with the requirements of the Contraception, Sterilisation and Abortion Act 1977. Products must comply with the appropriate approved Standards for contraceptives.
Legislation
All contraceptives devices supplied in New Zealand must comply with the Medicines Act 1981 and the Contraception, Sterilisation and Abortion Act 1977. The Medicines Act 1981 provides the definitions that indicate whether contraceptives are medicines or medical devices. The Contraception, Sterilisation, and Abortion Act 1977 established the requirement for contraceptive devices to comply with Standards approved by the Minister of Health.
Approved standards
Section 6 of the Contraception, Sterilisation, and Abortion Act 1977 requires the Minister of Health to approve Standards for contraceptive devices. Only products meeting all of the requirements of the appropriate Standard may be legally supplied in New Zealand. As of 1 May 2014 the following Standards have been approved;
ISO 4074:2002e / Corrigenda 1:2003 - Natural Latex Rubber Condoms, Requirements and Test Methods (Refer the Gazette notice of 27 May 2004, No 60, page 1441.)
NZS 7106:1998 - Polyurethane Condoms (Refer the Gazette notice of 28 January 1999, No 8, page 199.)
ISO 23409:2011 - Male Condoms - Requirements and test methods for condoms made from synthetic materials (Refer the Gazette notice of 3 April 2014, No 36, page 1045)
ISO 25841:2011 - Female Condoms - Requirements and test methods (Refer the Gazette notice of 3 April 2014, No 36, page 1045)
NZS 7102:1980 - Specifications for Intra-Uterine Contraceptive Devices (Refer the Gazette notice of 16 August 1984, No 143, page 3175.)
ISO 7439:2011 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (Refer the Gazette notice of 3 April 2014, No 36, page 1045)
ISO 8009:2004 - Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms, requirements and tests (Refer the Gazette notice of 3 April 2014, No 36, page 1045)
Copies of these Standards are available for purchase from Standards New Zealand.
Penalties
Supply of contraceptives that do not meet the requirements of the approved Standards is a breach of the Contraception, Sterilisation, and Abortion Act 1977. The penalty for supply of such contraceptives is a fine not exceeding $5,000 per offence.
Medical devices supplied in New Zealand must be notified to the WAND database in accordance with the Medicines (Database of Medical Devices) Regulations 2003. The penalty for failure to notify a medical device to the database is a fine not exceeding $500 per offence, and if the offence is a continuing one, a further fine of $50 per day or part day during which the offence continues, applies.
Quality program
As the Contraception, Sterilisation and Abortion Act 1977 requires compliance with certain Standards, Medsafe recommends that all companies marketing condoms in New Zealand ensure that each batch of product meets the Standard. This can be achieved by ensuring every batch of condoms is tested against the requirements of the prescribed Standard (ideally by an independent laboratory) before releasing the batch for supply. Medsafe can provide information on companies known to provide a condom testing service.
