Medical Devices
Requirements for Condoms and Contraceptive Devices
Condoms and contraceptive devices supplied in New Zealand must meet the requirements of several Acts, Regulations and Standards. These include;
- The Medicines Act 1981
- The Contraception, Sterilisation and Abortion Act 1977
- The Medicines (Database of Medical Devices) Regulations 2003
- International Standard ISO 4074:2002(E) for Natural Latex Rubber Condoms
- New Zealand Standard NZS 7106:1998 for Polyurethane Condoms
- British Standard BS4028:1966 with amendments for Reusable Contraceptive Diaphragms
- New Zealand Standard NZS 7102:1980 for Intra-Uterine Contraceptive Devices
Additionally there is an expectation by Medsafe that importers of condoms will be able to assure the quality of every batch of condoms imported into New Zealand. For more details about the condom quality monitoring program click here.
Failure to meet the requirements constitutes breaches of the above Acts and Regulations. For information about the penalties for breaching these requirements please click here.
Companies wishing to import and supply condoms and/or contraceptive devices in New Zealand should contact Robert Jelas at Medsafe to discuss their plans.
The Medicines Act 1981
Condoms that contain a spermicide or topical anaesthetic, and Intra-Uterine Contraceptive Devices (IUDs) are classified as medicines under the Medicines Act 1981 and consent for their distribution must be sought from and given by the Minister of Health before they can be distributed in New Zealand. Information about lodging a new medicine application is available from Guidelines & Codes on this website.
If a condom does not contain a spermicide or topical anaesthetic it is classified as a medical device. Sponsors of medical devices sold in New Zealand are required to comply with the Medicines (Database of Medical Devices) Regulations 2003.
The Contraception, Sterilisation and Abortion Act 1977
Section 6 of this Act grants the Minister of Health the power to gazette (mandate) Standards for condoms and contraceptive devices supplied in New Zealand. Contraceptive devices with Standards currently gazetted (mandated) under this Act are;
Natural Latex Rubber Condoms must comply with the International Standard ISO 4074:2002(E) for Natural Latex Rubber Condoms. Refer the Gazette Notice of 27 May 2004, No 60, page 1441
Polyurethane condoms must comply with New Zealand Standard NZS 7106:1998 for Polyurethane Condoms. Refer the Gazette Notice of 28 January 1999, No 8, page 199.
Re-useable Rubber Diaphragms must comply with British Standard BS 4028:1966, with amendments AMD 975 (June 1972) and AMD 1578 (October 1974), Specifications for Reuseable Contraceptive Diaphragms. Refer the Gazette Notice of 12 October 1978, No 86, page 2768.
Intra-Uterine Contraceptive Devices must comply with New Zealand Standard NZS 7102:1980 Specification for Intra-Uterine Contraceptive Devices. Refer the Gazette Notice of 16 August 1984, No 143, page 3175.
Medicines (Database of Medical Devices) Regulations 2003
These regulations require a sponsor (importer/manufacturer) to notify the Director-General of Health within 30 days of becoming the sponsor of a medical device (including condoms) in New Zealand, of the details of the device to the Web Assisted Notification of Devices (WAND) Database.
The Regulations require the following information to be notified on the WAND database;
Name of the manufacturer
The address of the registered office or principal place of business of the manufacturer (whether in New Zealand or overseas)
Name of the sponsor (the importer of the devices)
The address or the registered office or principal place of business in NZ of the sponsor
A contact telephone number or email address for both the manufacturer and the sponsor
The product description attributed to the device by the manufacturer from the Global Medical Device Nomenclature system (GMDN)
The risk classification of that device
Medsafe strongly encourages all sponsors of medical devices to also obtain and hold a copy of the manufacturer's Certificate of Conformity as part of their records.
Details about the WAND database can be found on this website under WAND-Medical Devices.
ISO 4074:2002(E) for Natural Latex Condoms
This international standard sets out the requirements to be met for latex condoms. The standard includes: quality acceptance criteria, testing methods, labeling requirements, instructions for use and packaging requirements. Copies of this standard are available from Standards New Zealand.
NZS 7106:1998 for Polyurethane Condoms
Polyurethane condoms supplied in New Zealand must meet this local standard which sets out the requirements for: quality acceptance criteria, testing methods, labeling requirements, instructions for use and packaging requirements. Copies of this standard are available from Standards New Zealand.
Condoms Manufactured From Materials Other Than Natural Latex and Polyurethane
Condoms supplied in New Zealand must comply with the Standards gazetted by the Minister of Health, as required by Section 6 of the Contraception, Sterilisation and Abortion Act 1977. At this time the only Standards gazetted are for condoms manufactured from Natural Latex and from Polyurethane. Condoms manufactured from other materials may not be supplied in New Zealand. Supply of condoms manufactured from other materials would be in breach of Section 6 of the Contraception, Sterilisation and Abortion Act 1977.
BS 4028:1966 with amendments for Specification for Reusable Contraceptive Diaphragms
Reusable Contraceptive Diaphragms supplied in New Zealand must meet this British Standard which sets out the requirements for: quality criteria, testing methods, and labeling requirements.
NZS 7102:1980 Specification for Intra-Uterine Contraceptive Devices
Intra-Uterine Contraceptive Devices (IUDs) supplied in New Zealand must meet this local standard which sets out the requirements for: quality acceptance criteria, testing methods, labeling requirements, instructions for use and packaging requirements. Copies of this standard are available from Standards New Zealand.
Quality Monitoring Program
Condoms must meet the requirements of Standards gazetted under the Contraception, Sterilisation and Abortion Act 1977. The Act determines the Standard that condoms must conform to in order to be supplied in the New Zealand market. Section 40 of the Medicines Act 1981 also requires all medical devices and medicines for which Standards are set, to meet those Standards.
Medsafe recommends that all companies marketing condoms in New Zealand have every batch of imported condoms tested against the requirements of the prescribed Standard by an independent laboratory before releasing the batch for supply. Medsafe can provide information on companies known to provide a condom testing service.
Penalties for Breaches of Legislation
Condoms that contain a spermicide or a topical anaesthetic, and Intra-Uterine Devices (IUDs) are medicines and the Minster of Health must give consent to their sale or distribution prior to this taking place. Failure to obtain consent is a breach of Section 20 of the Medicines Act 1981 and, on conviction, carries a fine of up to $100,000 for a body corporate or, for an individual, a fine of up to $20,000 or a prison sentence of up to six (6) months.
Section 6 of the Contraception, Sterilisation and Abortion Act 1977 mandates the Standards that must be met for condoms and contraceptive devices in order to be supplied on the New Zealand market. Failure to comply with that Act may result in a fine not exceeding $5,000 per offence.
Regulation 9 of the Medicines (Database of Medical Devices) Regulations 2003 requires the sponsor to notify the medical device into the WAND database. Failure to meet this requirement may result in imprisonment for a term not exceeding 3 months or a fine not exceeding $500 per offence, and if the offence is a continuing one, to a further fine not exceeding $50 per day for every day or part of a day during which the offence has continued (Section 78 of the Medicines Act 1981).
Companies wishing to import and supply condoms and/or contraceptive devices in New Zealand should contact Robert Jelas at Medsafe to discuss their plans.
Other/External Links
Guidelines & Codes - http://www.medsafe.govt.nz/regulatory/guidelines.asp
WAND-Medical Devices - http://www.medsafe.govt.nz/regulatory/wand.asp
Standards New Zealand - http://www.standards.govt.nz/default.htm
Polyurethane condoms - http://www.medsafe.govt.nz/regulatory/Guideline/condoms.asp