Australia · Medical Devices

Vigilance Reporting in Australia

A practical guide to Vigilance Reporting for medical devices sold in Australia: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Serious incidents and field safety actions must be reported within the local timelines; Brands distributing devices through local partners

Authority

Therapeutic Goods Administration

Legal basis

Therapeutic Goods Act 1989

Local representative

A local licence holder or authorised representative is required

Timeline

Registration can take months; plan early

Cost

Clinical evidence and QMS audits dominate cost

If you do not comply

Import ban, seizure, and enforcement action

Who needs this

Serious incidents and field safety actions must be reported within the local timelines
Brands distributing devices through local partners

Documents you need

Vigilance procedure and incident log
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Vigilance procedure and incident log
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

How to comply

Set up incident reporting within the deadline
Classify the device under local rules
Prepare technical documentation
Complete registration or notification

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Vigilance Reporting — Australia
Product category: Medical Devices
Authority: Therapeutic Goods Administration
Legal basis: Therapeutic Goods Act 1989

Documents we already have:
  1. Vigilance procedure and incident log
  2. Regulatory classification and registration
  3. Clinical or performance evidence
  4. Quality management system certificate

Questions:
  1. Does our product fall under Vigilance Reporting in Australia?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Registration can take months; plan early.

Clinical evidence and QMS audits dominate cost.

Common rejection reasons

Serious incident reported late
Wrong risk classification
Clinical evidence insufficient
QMS certificate not accepted

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs Vigilance Reporting in Australia?

Serious incidents and field safety actions must be reported within the local timelines Brands distributing devices through local partners.

What documents are required for Vigilance Reporting?

Vigilance procedure and incident log; Regulatory classification and registration; Clinical or performance evidence; and quality management system certificate.

What is the first step for Vigilance Reporting?

Set up incident reporting within the deadline. Registration can take months; plan early.

How long does Vigilance Reporting take?

Registration can take months; plan early.

How much does Vigilance Reporting cost?

Clinical evidence and QMS audits dominate cost.

What happens if I sell without it?

Import ban, seizure, and enforcement action.

Who regulates Vigilance Reporting in Australia?

Therapeutic Goods Administration.