Drugs and devices not approved in Japan

Treatment Using Medical Devices Not Approved
Under the PMD Act

This clinic provides orthodontic treatment using the Invisalign system, which uses a medical device that has not been approved under the Act on Pharmaceuticals and Medical Devices, etc. (the PMD Act).

* In accordance with the “Q&A on the Medical Advertising Guidelines” issued by the Ministry of Health, Labour and Welfare under the Medical Care Act, the following is provided to satisfy the “four requirements for lifting the advertising restriction.”

1. Disclosure that this is an unapproved drug or device

Invisalign

Invisalign has not been approved under the PMD Act.

2. Disclosure of how it is obtained

Invisalign

Invisalign® is a trademark of a product made by Align Technology, Inc. of the United States. This clinic uses the system of Align Technology, Inc. of the United States through Invisalign Japan K.K.

3. Disclosure of whether an approved equivalent exists in Japan

About clear aligner treatment

Orthodontic treatment with Invisalign is now carried out around the world, and is generally known as aligner orthodontics. In Japan it is known as clear aligner treatment, and various domestic brands of clear aligner appliance also exist.

About approval as a medical device

To be recognized in Japan as an “orthodontic appliance as a medical device,” a product must meet one of the following conditions.

• It is made using materials that have received pharmaceutical approval, by a dentist or dental technician who has passed Japan’s national examination.
• If it is a ready-made product, the product itself has received pharmaceutical approval.

4. Disclosure of safety information from other countries

Track record of use worldwide

Appliances for clear aligner treatment, including Invisalign, are sold by dozens of companies worldwide and are widely used. In the United States, about one-third of orthodontic treatment is carried out with clear aligner appliances.

Invisalign’s treatment track record

Invisalign has been used in a large number of cases worldwide and has a broad track record. No serious side effects have been reported beyond the individual risks associated with orthodontic treatment.

About the Adverse Drug Reaction Relief System

As Invisalign has not received approval under the PMD Act, it is not eligible for the Adverse Drug Reaction Relief System.

About clear aligner treatment (Invisalign)

This clinic provides clear aligner treatment using the Invisalign system.

Features of Invisalign

• Clear and inconspicuous
• Removable
• Relatively little pain
• No need to worry about a metal allergy
• Fewer clinic visits

Before starting treatment, we explain the treatment content, duration, cost, and risks to patients in detail, and begin treatment only once they are satisfied and in agreement.

Learn more about clear aligner treatment

Learn more about orthodontics

If you have any questions or concerns about the use of unapproved drugs or devices, please feel free to talk to us. We will take the time to explain everything.