For orthodontic treatment, see a qualified orthodontic doctor in person and attend follow-ups; do not buy aligners online and wear them yourself at home

Compared with buying online, you pay for consultations and follow-ups and visit a clinic periodically. The hard part is attending follow-ups throughout treatment, often one or two years.

The Center for Medical Device Evaluation of China’s National Medical Products Administration stated in its 2022 registration-review guidance for bracket-free orthodontic appliances that these aligners are Class II devices. Instructions must state that they should be worn under the guidance of a physician with professional orthodontic qualifications during treatment, and include requirements for eating, toothbrushing, and regular follow-ups. Product names are advised not to include vague or hypothetical concepts such as “invisible.” The US Food and Drug Administration (FDA) says it has not authorized clear aligners sold directly to consumers without a prescription and supervision by a dentist or orthodontist. It also says an in-person examination can help reduce the risks of uneven bite, unintended tooth movement, pain, and tooth loss. Regular in-person follow-ups after starting aligners help confirm that teeth are moving safely as planned. Both sources are regulatory documents and give no incidence figures.

国家药品监督管理局医疗器械技术审评中心 (2022). 无托槽矫治器注册审查指导原则（2022 年第 41 号）. https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230103095116100.html；国家卫生健康委办公厅等 (2023). 关于进一步推进口腔医疗服务和保障管理工作的通知（国卫办医政发〔2023〕11 号，第五条）. https://www.gov.cn/zhengce/zhengceku/202309/content_6903786.htm；U.S. Food and Drug Administration (2026). Clear Dental Aligners（页面 2026 年 9 月 9 日更新）. https://www.fda.gov/medical-devices/dental-devices/clear-dental-aligners

Benefit magnitude is rated small because no incidence figures were found, so the judgment is based only on consequences. No Chinese drug-regulation or health-authority risk notice specifically addressing buying aligners online and wearing them at home was found, so this item relies mainly on registration requirements and FDA statements. Orthodontics is medical treatment. For cosmetic orthodontic treatment, the institution’s license must cover the relevant specialty and the treating doctor must be qualified; see Item 2 in this section (institutional license and lead physician) for how to check. A 2023 dental-care notice from four departments also explicitly requires strict penalties for unlicensed institutions and those employing non-healthcare personnel to provide dental care. Orthodontics is not reimbursed by medical insurance; see Section 24, Item 12 (ask what the package price includes before getting an implant).