What happens
A medical device that has not been approved in Japan cannot be imported as it stands.
For exhibition, however, you can bring it in and display it once you hold an import confirmation certificate.
Even then, it cannot be sold or transferred at the venue.
Why this happens
Medical devices bear directly on people's health and lives.
Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, importing a device in order to sell it requires a marketing business licence and an approval or certification for each item.
To bring in an unapproved device for exhibition, you apply to the Regional Bureau of Health and Welfare and receive an import confirmation certificate.
A product that circulates without difficulty in other markets still needs this step if it has no Japanese approval.
Check the official sources
- Personal imports of pharmaceuticals and cosmetics (Japan Customs, Answer 1806)
- What customs checks under the pharmaceutical and medical device law (Japan Customs, Answer 1805)
- Q&A on import procedures for pharmaceuticals (Kanto-Shinetsu Regional Bureau of Health and Welfare)
- Guidelines for import confirmation (Kinki Regional Bureau of Health and Welfare)
- Exhibition request form, Form 7 (Kanto-Shinetsu Regional Bureau of Health and Welfare)
These cover the customs check on commercial imports (1805), the personal import route (1806), and the import confirmation for exhibition with the documents it needs (Q&A Q34, guidelines section 4(5), Form 7).
Bringing it into Japan
Most exhibits clear customs on the temporary import procedure alone.
Medical devices need one more thing: compliance with the pharmaceutical and medical device law.
To bring in an unapproved device for exhibition, you apply to the Regional Bureau of Health and Welfare with an exhibition request form from the show organiser, and receive an import confirmation certificate.
Which procedures apply depends on the intended use and the specification.
Taking it back out of Japan
If the country you are returning to restricts imports of medical devices, check separately.
How KUROZAKI helps
Before move-in, we check what your device needs.
Where a procedure is required, we support the application.
If you are not sure
If you are unsure whether your device can be brought in as an exhibit, talk to us before you exhibit.