Disclosure of Unapproved Drugs and Medical Devices
Treatment Using a Medical Device Not Approved
Under the PMD Act
At 歯科ハミール高田88, we provide “clear aligner orthodontic treatment using the Invisalign System,” a treatment that uses a medical device not approved under the Pharmaceuticals and Medical Devices Act (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 information below is provided to satisfy the “four requirements for lifting the advertising restrictions.”
1. Disclosure That This Is an Unapproved Drug or Medical Device
About the Invisalign System
Invisalign has not received approval under the PMD Act.
The Invisalign System used at our clinic is a medical device manufactured by Align Technology, Inc. of the United States. It is a medical device that has not received regulatory approval in Japan.
2. Disclosure of How It Is Obtained
How Invisalign Is Obtained
Invisalign is a trademark of a product made by Align Technology, Inc. of the United States. Our clinic uses Align Technology’s system through Invisalign Japan K.K.
The treatment plan is created by a dentist in Japan, but the actual aligners (mouthpieces) are manufactured by Align Technology, Inc. at factories overseas.
3. Disclosure of Whether an Approved Equivalent Exists in Japan
About Clear Aligner Orthodontic Devices
Clear aligner orthodontic treatment using Invisalign is now widely practiced around the world, and many dental clinics in Japan have adopted it as well. A variety of brands of clear aligner orthodontic device also exist within Japan.
To be recognized in Japan as an “orthodontic device classified as a medical device,” a device must be made using materials that have received regulatory approval, by a dentist or dental technician holding a Japanese national qualification. In the case of a ready-made product, the product itself must have received regulatory approval.
Approval Status of the Invisalign System
The Invisalign System has received regulatory approval for the aligner material and for the intraoral scanning device (iTero).
However, the manufacturing process itself falls outside the scope of the PMD Act, for the following reason: the treatment plan is designed by a dentist in Japan, but the actual aligners are manufactured overseas by an automated system, so this manufacturing process is not subject to PMD Act regulation.
Note that some similar clear aligner orthodontic devices manufactured within Japan have received regulatory approval.
4. Disclosure of Safety Information From Other Countries
Invisalign’s Track Record and Safety
Devices for clear aligner orthodontic treatment, including Invisalign, are manufactured and sold by dozens of companies worldwide. In the United States in particular, roughly a third of orthodontic treatment is carried out using clear aligner devices.
Invisalign has been used around the world since it was developed in the United States in 1997, and as of 2020 it had been used in more than 9 million cases worldwide in total. Many cases have also been reported across Asia, including Japan.
Based on its track record to date, no serious side effects beyond the general risks associated with orthodontic treatment have been reported. That said, depending on the individual patient’s symptoms and the course of treatment, an unexpected reaction may occur.
About the Relief System for Sufferers from Adverse Drug Reactions
Because Invisalign has not received approval under the PMD Act, it is not covered by the Relief System for Sufferers from Adverse Drug Reactions, if a side effect occurs.
Before beginning treatment, we provide a full explanation of these risks and move forward only once you understand them. If you have any questions or concerns, just ask us.
Features of Invisalign Treatment at Our Clinic
At 歯科ハミール高田88, we take the following approach to Invisalign treatment.
Our clinic uses iTero (an intraoral scanner) to capture precise dental impression data. Compared with a conventional impression, this reduces the burden on patients while allowing a more accurate treatment plan to be designed.
Before treatment begins, a 3D simulation lets you see how your teeth will be aligned afterward. Knowing in advance how your own teeth will move helps you go into treatment feeling at ease.
Learn more about clear-aligner orthodontics
If you have any questions or concerns about the use of this unapproved drug or medical device, just ask us. We will explain the details and answer your questions before treatment. Please contact us.