United States · Medical Devices

Post-Market Surveillance in the United States

A practical guide to Post-Market Surveillance for medical devices sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Manufacturers must monitor device performance and report trends after sale; Brands distributing devices through local partners

Authority

U.S. Food and Drug Administration

Legal basis

21 CFR Part 814

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

Manufacturers must monitor device performance and report trends after sale
Brands distributing devices through local partners

Documents you need

Post-market surveillance plan and reports
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.

Post-market surveillance plan and reports
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

How to comply

Set up post-market data collection
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: Post-Market Surveillance — United States
Product category: Medical Devices
Authority: U.S. Food and Drug Administration
Legal basis: 21 CFR Part 814

Documents we already have:
  1. Post-market surveillance plan and reports
  2. Regulatory classification and registration
  3. Clinical or performance evidence
  4. Quality management system certificate

Questions:
  1. Does our product fall under Post-Market Surveillance in the United States?
  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

No surveillance data after launch
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 Post-Market Surveillance in the United States?

Manufacturers must monitor device performance and report trends after sale Brands distributing devices through local partners.

What documents are required for Post-Market Surveillance?

Post-market surveillance plan and reports; Regulatory classification and registration; Clinical or performance evidence; and quality management system certificate.

What is the first step for Post-Market Surveillance?

Set up post-market data collection. Registration can take months; plan early.

How long does Post-Market Surveillance take?

Registration can take months; plan early.

How much does Post-Market Surveillance cost?

Clinical evidence and QMS audits dominate cost.

What happens if I sell without it?

Import ban, seizure, and enforcement action.

Who regulates Post-Market Surveillance in the United States?

U.S. Food and Drug Administration.