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Appointing a Sponsor

When you need to appoint a Sponsor​

Any manufacturer without a legal presence in New Zealand must appoint a NZ Sponsor before supplying devices in New Zealand. The Sponsor must be in place before WAND notification — and WAND notification must be complete before supply begins.

Who to appoint​

You have several options for who acts as your NZ Sponsor:

1. Your NZ importer or distributor​

The most common arrangement. Your NZ distributor takes on the Sponsor role alongside their commercial relationship. This is efficient — one party manages both logistics and regulatory obligations.

Pros: Single point of contact; distributor already knows the product
Cons: Sponsor liability is with your commercial partner; if the relationship ends, a WAND transfer is needed

2. A regulatory affairs firm or professional Sponsor service​

Several NZ-based regulatory consultancies offer Sponsor services — acting as Sponsor for manufacturers with no other NZ presence.

Pros: Specialist regulatory knowledge; separation of regulatory and commercial roles
Cons: Additional cost; may not have deep product knowledge

3. A NZ subsidiary of your company​

If your organisation establishes a NZ entity (e.g., a registered company), that entity can act as Sponsor directly.

Pros: Full control over regulatory obligations
Cons: Cost and time of establishing a NZ legal entity

What to include in a Sponsor agreement​

A formal written agreement between the manufacturer and Sponsor should cover:

  • Scope — which devices are covered
  • WAND — who is responsible for initial notification and ongoing updates
  • Documentation access — the manufacturer must provide the Sponsor with technical documentation, conformity evidence, and safety information on request
  • Adverse event reporting — how safety information flows between manufacturer and Sponsor; who reports to Medsafe
  • Recall and FSCA obligations — notification timelines and coordination
  • Termination — notice periods and WAND transfer obligations when the relationship ends
  • Insurance — product liability coverage requirements
  • Costs — who bears regulatory costs (WAND fees are nil, but Sponsor time has cost)

Finding a Sponsor in New Zealand​

There is no official Medsafe directory of Sponsors or regulatory affairs service providers. Options for finding a Sponsor include:

  • Industry associations such as MTAA New Zealand — Medical Technology Association of Australia (which covers NZ members)
  • Regulatory affairs consultants based in New Zealand
  • Existing NZ distribution partners
  • The Regulatory Affairs Professionals Society (RAPS) NZ chapter
Plan for Sponsor changes

Include clear exit provisions in your Sponsor agreement from day one. If your Sponsor relationship ends without an agreed WAND transfer process, devices can be left without active WAND entries — a compliance gap.