Orthodontic treatment requires an orthodontist with proper credentials to conduct an in-person exam and schedule regular follow-ups — don’t buy aligners online and wear them at home on your own

Cost: It costs more than buying aligners online, as you’ll need to pay for doctor visits and follow-up appointments at set intervals. The main challenge is that treatment often lasts one to two years, so you must keep up with all scheduled checkups.

In plain terms: Clear aligners are classified as Class II medical devices in China, and their instructions explicitly state they must be worn under the supervision of a qualified orthodontist, with regular follow-ups required. The US Food and Drug Administration has never approved any clear aligners sold directly to consumers without a prescription and oversight from a dentist or orthodontist. Without an in-person exam first, you risk developing a misaligned bite, unwanted tooth movement, pain, or even tooth loss.

Benefit: According to the 2022 Guidelines for Registration Review of Aligner Orthodontic Devices issued by China’s National Medical Products Administration, clear aligners fall under Class II medical device regulation. These guidelines require product instructions to specify that treatment must be supervised by a qualified orthodontist, and to outline rules for eating, brushing, and regular follow-ups. They also state that product names must not include vague, hypothetical terms like “invisible”. The FDA’s official stance is identical: “The FDA has not authorized clear aligners that are sold directly to consumers without a prescription and supervision by a dentist or orthodontist.” It also notes that “In-person examination by a dentist or orthodontist can help lower the risks of uneven bite, unintended tooth movement, pain, and tooth loss.” Regular in-person follow-ups after starting treatment are essential to confirm teeth are moving as planned and safely. Neither document provides statistics on how often adverse events occur.

Evidence grade: C

Sources: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

Notes: The potential benefits are rated as minor here, as no data on actual adverse event rates is available — we can only judge based on known risks. No official warnings from Chinese regulatory or health authorities about the risks of buying aligners online and wearing them at home have been found, so this entry relies primarily on registration requirements and FDA statements. Orthodontic treatment is a medical procedure; any cosmetic dental correction must be performed at a clinic with the proper license, by a qualified doctor. How to verify these credentials is outlined in Section 2 of this chapter. A 2023 joint notice from four government departments also calls for strict punishment of unlicensed clinics and those employing unqualified staff to provide dental care. Orthodontic treatment is not covered by medical insurance, as noted in Section 24, Item 12.