Chapter 1 New Zealand MEDSAFE administration information abstract

1. Administration and Abstract

New Zealand MEDSAFE (Medicines and Medical Devices Safety Authority) is the authority of New Zealand government which be responsible for the supervision and administration of medical devices and other medical products. It is responsible for the registration of medical products in New Zealand, the formulation of regulations and market supervision.

2. Administrative Regulation

Medicines Act 1981

Medicines Regulations 1984

3. Risk Level Classification of Medical Device and IVD Products

All medical devices are classified according to a risk-based approach which is similar to the EU and US FDA classification systems, ranging from Class I (Basic/sterilized/measured), IIa, IIb to III.

4. Entry Requirements

ISO 13485

Technical Documents: Manufacturers must submit detailed technical documents, including product specifications, quality standards, manufacturing processes, risk assessment reports, etc., to demonstrate the safety and effectiveness of the product.

5. Registration Language

English.

Chapter 2 Cycle & Official Fee

Cycle

Medsafe usually takes about 1 month to complete the registration of medical products after receiving all the necessary documents and information.

Official Fee

Registration cycles may vary depending on product type, complexity and other factors.

New Zealand MEDSAFE does not currently charge official fees.

Chapter 3 FAQ

Q: Whether the WAND list has an expiration date limit?

A: In New Zealand, there is no expiration date limit on the marking list of medical devices. However, if a medical device is deemed to pose an unacceptable hazard to the public, it may be required to be withdrawn from the market.