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Technical documentation

No mandatory format​

New Zealand does not prescribe a specific format or content list for technical documentation. There is no "Technical File" equivalent mandated by regulation. However, Medsafe may request documentation at any time to verify that a device is safe and performs as intended.

The practical standard is: hold documentation that would satisfy a regulator who knows what good looks like.

What to include​

For most devices, a complete documentation package for the NZ market would include:

Device description​

  • Device name, model numbers, and variants
  • Intended purpose and intended users
  • Principle of operation
  • List of accessories and accessories' intended purpose

Design and manufacturing information​

  • Materials of construction
  • Sterilisation method (if applicable)
  • Manufacturing site(s)

Risk management​

  • Risk management file in accordance with ISO 14971
  • Benefit-risk analysis

Conformity evidence​

  • CE certificate, TGA ARTG listing, FDA clearance, or Health Canada licence (any of these suffices)
  • Alternatively: full technical testing evidence (biocompatibility, electrical safety, performance testing, etc.)

Clinical or performance evidence​

  • Clinical evaluation report (for non-IVDs) or Performance evaluation report (for IVDs)
  • Literature review or clinical study data
  • Post-market clinical follow-up data (where available)

Labelling​

  • Final approved labels
  • Instructions for use (IFU)

Quality management​

  • ISO 13485 certificate (if held)
  • Relevant QMS procedures

Leveraging existing documentation​

If your device holds CE marking, TGA ARTG listing, or FDA clearance, your existing technical file or design dossier will generally be sufficient for NZ purposes. You do not need to create a separate NZ-specific technical file.

The Sponsor should ensure they:

  • Have access to the technical documentation (not just a copy of the CE certificate)
  • Can provide it to Medsafe within a reasonable timeframe if requested
  • Are notified by the manufacturer of any updates to the documentation that affect the NZ market device

Document retention​

There is no explicit document retention period prescribed in the WAND Regulations. Best practice (and alignment with other market requirements) is to retain technical documentation for:

  • At least 5 years from the date of supply of the last device of that model
  • At least 15 years for implantable devices

Sponsors should ensure the manufacturer agrees to retain documentation for this period and to provide it to the Sponsor on request even after the commercial relationship ends.