Japan · Medical Devices

Device Import Licence in Japan

A practical guide to Device Import Licence for medical devices sold in Japan: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

The local importer must hold the licence that covers the device class; Brands distributing devices through local partners

Authority

Pharmaceuticals and Medical Devices Agency

Legal basis

Pharmaceuticals and Medical Devices Act

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

The local importer must hold the licence that covers the device class
Brands distributing devices through local partners

Documents you need

Importer licence
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.

Importer licence
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

How to comply

Verify the importer licence covers the class
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: Device Import Licence — Japan
Product category: Medical Devices
Authority: Pharmaceuticals and Medical Devices Agency
Legal basis: Pharmaceuticals and Medical Devices Act

Documents we already have:
  1. Importer licence
  2. Regulatory classification and registration
  3. Clinical or performance evidence
  4. Quality management system certificate

Questions:
  1. Does our product fall under Device Import Licence in Japan?
  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

Importer licence does not cover the device
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.