In Vitro Diagnostic Devices Regulatory Framework in New Zealand

1. Definition and Scope

In vitro diagnostic (IVD) devices are medical devices intended for in vitro examination of specimens derived from the human body for the purpose of providing information on physiological state, health, disease, congenital abnormality, or to determine safety and compatibility for transfusion or transplantation. This includes reagents, instruments, specimen receptacles, calibrators, control materials, and software. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

IVDs are regulated under the Medicines Act 1981 and the Medicines (Database for Medical Devices) Regulations 2005 as medical devices, with specific classification rules and conformity assessment requirements tailored to IVDs. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

2. Risk Classification for IVDs

IVD devices are classified into four classes based on the risk posed by incorrect results:

• Class 1: Low individual and public health risk (e.g., general laboratory reagents, instruments without specific high-risk claims, certain non-critical tests).
• Class 2: Moderate individual risk / low public health risk (e.g., most self-test kits, many routine clinical chemistry and immunology tests).
• Class 3: High individual risk / moderate public health risk (e.g., tests for sexually transmitted agents, genetic tests, cancer markers).
• Class 4: High individual and public health risk (e.g., high-risk blood and tissue screening tests, confirmatory tests for HIV, hepatitis B/C, syphilis, and certain transfusion-related tests).

Classification follows seven specific rules, considering intended use, specimen type, and consequences of false results. Self-testing and near-patient testing IVDs often fall into higher classes due to user-related risks. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

3. Conformity Assessment Requirements

Manufacturers must demonstrate compliance with essential principles of safety and performance through conformity assessment procedures appropriate to the IVD class:

• Class 1: Manufacturer self-declaration usually sufficient.
• Class 2, 3, and 4: Increasing levels of third-party involvement (e.g., conformity assessment body certification for higher classes).
• Evidence may include technical documentation, risk management files, performance evaluation data, and recognised standards (e.g., ISO 13485 for quality management).

Overseas approvals from comparable jurisdictions (e.g., EU IVDD/IVDR, Australian TGA) may support conformity assessment. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

4. WAND Notification and Sponsor Responsibilities

Before supplying an IVD in New Zealand, the sponsor must notify details to the WAND database, including classification, GMDN code, intended purpose, and conformity evidence. Sponsors are responsible for:

• Maintaining distribution records
• Reporting adverse events, including false results leading to harm
• Conducting post-market performance follow-up
• Cooperating with Medsafe investigations

Additional vigilance applies to high-risk IVDs (Class 3 and 4). Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

5. Labelling, Instructions, and Information Supply

Labelling must be in English and include:

• Device description and intended purpose
• Performance characteristics (sensitivity, specificity, etc.)
• Instructions for use, including specimen requirements and interpretation of results
• Warnings, limitations, and contraindications
• Manufacturer/sponsor details, batch/lot, and expiry

For self-testing IVDs, additional user-friendly instructions and interpretation guidance are required. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

6. Advertising and Promotion Restrictions

Advertising IVDs to the public is restricted, especially for self-testing devices. Prohibited or controlled claims include:

• Implying diagnosis without professional confirmation
• Guaranteeing accuracy or absence of false results
• Targeting vulnerable groups inappropriately

All therapeutic or diagnostic claims must be substantiated, and certain advertisements require prior approval. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

7. Post-Market Surveillance and Additional Requirements

Medsafe monitors IVDs through mandatory adverse event reporting, field safety corrective actions, and periodic reviews. High-risk IVDs (especially Class 4) may require ongoing performance monitoring or additional clinical evidence post-market. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp

The framework aligns with international standards (e.g., IMDRF, EU IVDR) to facilitate global harmonization while ensuring appropriate oversight for IVDs in New Zealand. Source: https://www.medsafe.govt.nz/regulatory/DevicesNew/7InVitro.asp