Information for Medical Device Suppliers
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. Some products considered to be contraceptive devices in other countries are medicines in New Zealand.
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.
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 March 2011 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.)
NZS 7102:1980 - Specifications for Intra-Uterine Contraceptive Devices (Refer the Gazette notice of 16 August 1984, No 143, page 3175.)
BS 4028:1966 with amendments AMD 975 (June 1972) and AMD 1578 (October 1974) - Specification for Reusable Contraceptive Diaphragms (Refer the Gazette notice of 12 October 1978, No 86, page 2768.)
Copies of these Standards are available for purchase from Standards New Zealand.
Non-Natural Latex Rubber Condoms
Condoms manufactured from materials other than natural latex rubber or polyurethane may not be supplied in New Zealand as there are no approved Standards for these products. Medsafe is aware of a Standard being developed for non-natural latex rubber condoms. Once the Standard is published this may be assessed and may be recommended to the Minister of Health for approval.
The only Standard applicable to female condoms is NZS 7106:1998 for polyurethane condoms. Female condoms manufactured from materials other than polyurethane may not be supplied in New Zealand. Medsafe is aware of a Standard being developed for female condoms. Once the Standard is published this may be assessed and may be recommended to the Minister of Health for approval.
Categorisation of Contraceptives
Some contraceptives that are categorised as medical devices in other countries are medicines in New Zealand and must be approved before they can be supplied. The table below summarises the key types of contraceptives and their regulatory pathway.
|Condom with spermicide||Medicine|
|Condom with topical anaesthetic||Medicine|
Contraceptives categorised as medicines (refer above) that are supplied in New Zealand without approval are in breach of the Medicines Act 1981. The penalty for supply of unconsented (unapproved) medicines is a fine not exceeding $100,000 for a body corporate, or for an individual, a fine not exceeding $20,000 or imprisonment of up to six months.
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.
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.
Page last updated 10 May 2011