Contraceptive Devices Regulatory Requirements in New Zealand

1. Regulatory Classification and Status

Contraceptive devices are regulated as medical devices under the Medicines Act 1981 and the Medicines (Database for Medical Devices) Regulations 2005. They are classified as high-risk products, typically falling into Class IIb or Class III depending on their design and mechanism (e.g., intrauterine devices, diaphragms, and certain barrier methods). This classification reflects the potential consequences of failure (unintended pregnancy) and the invasive or long-term nature of many contraceptive devices. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

Due to their high-risk status, contraceptive devices require more stringent conformity assessment procedures, including third-party involvement for most classes, and must be notified to the WAND database before supply. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

2. Conformity Assessment Requirements

Manufacturers must demonstrate compliance with the essential principles of safety and performance through appropriate conformity assessment procedures aligned with the device's risk class. Acceptable evidence includes:

• Declarations of conformity supported by recognised standards (e.g., ISO standards for specific contraceptive devices)
• Certification from a conformity assessment body (notified body equivalent) for higher-risk classes
• Technical documentation demonstrating design verification, risk management, and clinical evidence where required

Overseas approvals from comparable regulatory jurisdictions (e.g., EU CE marking, Australian TGA approval) may be accepted as supporting evidence. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

3. WAND Notification and Sponsor Obligations

Before supplying a contraceptive device in New Zealand, the sponsor must notify details to the WAND database, including classification, GMDN code, intended purpose, and evidence of conformity. Sponsors remain responsible for:

• Maintaining distribution records
• Reporting adverse events and field safety corrective actions to Medsafe
• Conducting post-market surveillance
• Ensuring ongoing compliance with essential principles

Custom-made contraceptive devices (if any) may qualify for exemption from notification under specific conditions. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

4. Labelling and Instructions for Use

Labelling must be in English and include comprehensive information such as:

• Device description and intended purpose (including contraceptive efficacy claims supported by evidence)
• Instructions for correct use, insertion/removal (where applicable), and duration of use
• Warnings, precautions, contraindications, and potential risks/side effects
• Manufacturer and sponsor details, batch/lot number, and expiry date

Specific requirements apply to intrauterine devices (e.g., inclusion of patient information leaflets) and other implantable/long-acting contraceptives. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

5. Advertising Restrictions

Advertising contraceptive devices directly to the public is strictly controlled under the Medicines Act 1981. Key restrictions include:

• Prohibition of claims implying 100% effectiveness or guaranteeing prevention of pregnancy
• No misleading statements about ease of use, reversibility, or absence of side effects
• Requirement for balanced information including efficacy rates (e.g., Pearl Index), failure risks, and need for additional contraception in certain circumstances
• Advertisements must not target minors or imply use without medical consultation where appropriate

Therapeutic claims must be substantiated, and advertisements require approval in some cases. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

6. Post-Market Vigilance and Enforcement

Medsafe monitors contraceptive devices through:

• Mandatory reporting of adverse events (e.g., perforation, expulsion, unintended pregnancy)
• Review of field safety notices and recalls
• Periodic safety update reports for certain high-risk devices
• Investigation of complaints or non-compliance

Non-compliance may result in product prohibition, recall, or enforcement action against the sponsor. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

7. Additional Notes

The regulatory framework for contraceptive devices aligns closely with international standards (e.g., EU MDR) and facilitates recognition of overseas conformity assessments. Sponsors should consult Medsafe guidance or seek advice for specific products. The page provides links to related resources on classification, essential principles, and advertising codes. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp

This stringent approach ensures contraceptive devices supplied in New Zealand are safe, effective, and appropriately represented to users. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/6Contraceptive.asp