Purchase of 'Ounai'en' Clear Aligners Leads to Interrupted Treatment; TFDA Investigates Legality
Consumers in Taiwan who purchased clear aligner treatment from the brand 'Ounai'en' (歐耐恩) have reported not receiving the aligners and having their treatment interrupted. An investigation found no legal medical device license for this brand in the Taiwan FDA database. Legislator Chiu Hui-ju convened a coordination meeting. The TFDA has launched an investigation with local authorities and referred the case to prosecutors to determine if illegal medical devices are involved. The Consumer Protection Office reported approximately 200 related complaints from January to June 3 this year.
📋 Article Processing Timeline
- 📰 Published: June 4, 2026 at 14:52
- 🔍 Collected: June 4, 2026 at 15:04 (12 min after Published)
- 🤖 AI Analyzed: June 6, 2026 at 16:00 (48h 56m after Collected)
(Central News Agency, Reporter Tseng Yi-ning, Taipei, June 4) A member of the public reported purchasing a clear aligner treatment course from 'Ounai'en' (歐耐恩), but did not receive the aligners, leading to an interrupted treatment. Furthermore, no legal medical device license for this brand could be found. The Food and Drug Administration (TFDA) of the Ministry of Health and Welfare stated that it has investigated the matter jointly with local governments and has referred the case to prosecutors for clarification.
Taiwan People's Party Legislator Chiu Hui-ju today convened a coordination meeting titled 'Ounai'en Victims Treated Like Footballs, Unlicensed Aligners? Threatening Health?' She pointed out that in early 2024 (Minguo 113), consumers started receiving 'Ounai'en' clear aligner treatments at clinics including Haitang Dental Clinic. However, from the end of last year, incidents of undelivered aligners and interrupted treatments began to occur. In April of this year, Ounai'en became embroiled in a dispute with its partner clinics and completely halted supply.
Chiu stated that an investigation found no permit for 'Ounai'en Orthodontic Aligners'. Consumers may not only have failed to receive a complete treatment course but may have also used unlicensed, illegal aligners. She hopes that within two weeks to one month, relevant ministries and local governments can provide a satisfactory explanation to the complainants, both in terms of regulations and actual inspections.
A consumer surnamed Zheng, who purchased this aligner treatment, said the company falsely claimed to the credit card company that the aligners had been delivered in one batch, but in reality, no consumer received all aligners at once. This resulted in consumers' credit card installments being continuously charged even though they did not receive the aligners.
Another consumer surnamed Ke said she paid the full amount of over NT$100,000 in October last year but has not received any aligners. When she asked the manufacturer for a refund, they only offered a 40% refund after an assessment. Even when she sought help from consumer protection officers, they could not handle the case because the company refused to appear.
According to statistics from the Executive Yuan's Consumer Protection Office, from January to June 3 this year, there were approximately 200 related complaints, with about 78 second-stage complaints. Among all counties and cities, New Taipei City accounted for about half of the cases.
The Consumer Protection Office explained that if the company fails to deliver the aligners, consumers can file a consumer dispute complaint to claim damages. If there is injury due to not using the aligners, or dental deformation due to using problematic aligners, which involves a medical dispute, consumers can file for mediation regarding the medical dispute.
The Financial Supervisory Commission (FSC) pointed out that if payment was made by credit card, consumers can apply for a disputed charge with the card-issuing bank. The FSC will issue a letter to banking institutions, instructing them to set up a contact window for this case and post it on their official websites for consumer contact. For amounts not yet charged, the FSC will also inform card issuers that since the consumer did not actually receive the complete treatment, the bank should not pursue payment from the consumer.
Regarding whether this brand of clear aligners is a legal medical device, Chien Chia-hung, Director of the Medical Devices and Cosmetics Division of the TFDA, explained that the 'Ounai'en' brand of aligners is indeed not in the medical device database. However, if the aligners are provided by a legal dental lab or other legal manufacturer and then branded, they would be considered legal medical devices. Therefore, further clarification is needed to determine if they were supplied by another legal source.
Chien said that the New Taipei City Government Health Department has already investigated some evidence. However, it is still difficult to determine whether the aligners were manufactured by Ounai'en themselves or came from another legal source. The case has been referred to prosecutors for further clarification. (Editor: Hsieh Chia-chen) 1150604
Taiwan People's Party Legislator Chiu Hui-ju today convened a coordination meeting titled 'Ounai'en Victims Treated Like Footballs, Unlicensed Aligners? Threatening Health?' She pointed out that in early 2024 (Minguo 113), consumers started receiving 'Ounai'en' clear aligner treatments at clinics including Haitang Dental Clinic. However, from the end of last year, incidents of undelivered aligners and interrupted treatments began to occur. In April of this year, Ounai'en became embroiled in a dispute with its partner clinics and completely halted supply.
Chiu stated that an investigation found no permit for 'Ounai'en Orthodontic Aligners'. Consumers may not only have failed to receive a complete treatment course but may have also used unlicensed, illegal aligners. She hopes that within two weeks to one month, relevant ministries and local governments can provide a satisfactory explanation to the complainants, both in terms of regulations and actual inspections.
A consumer surnamed Zheng, who purchased this aligner treatment, said the company falsely claimed to the credit card company that the aligners had been delivered in one batch, but in reality, no consumer received all aligners at once. This resulted in consumers' credit card installments being continuously charged even though they did not receive the aligners.
Another consumer surnamed Ke said she paid the full amount of over NT$100,000 in October last year but has not received any aligners. When she asked the manufacturer for a refund, they only offered a 40% refund after an assessment. Even when she sought help from consumer protection officers, they could not handle the case because the company refused to appear.
According to statistics from the Executive Yuan's Consumer Protection Office, from January to June 3 this year, there were approximately 200 related complaints, with about 78 second-stage complaints. Among all counties and cities, New Taipei City accounted for about half of the cases.
The Consumer Protection Office explained that if the company fails to deliver the aligners, consumers can file a consumer dispute complaint to claim damages. If there is injury due to not using the aligners, or dental deformation due to using problematic aligners, which involves a medical dispute, consumers can file for mediation regarding the medical dispute.
The Financial Supervisory Commission (FSC) pointed out that if payment was made by credit card, consumers can apply for a disputed charge with the card-issuing bank. The FSC will issue a letter to banking institutions, instructing them to set up a contact window for this case and post it on their official websites for consumer contact. For amounts not yet charged, the FSC will also inform card issuers that since the consumer did not actually receive the complete treatment, the bank should not pursue payment from the consumer.
Regarding whether this brand of clear aligners is a legal medical device, Chien Chia-hung, Director of the Medical Devices and Cosmetics Division of the TFDA, explained that the 'Ounai'en' brand of aligners is indeed not in the medical device database. However, if the aligners are provided by a legal dental lab or other legal manufacturer and then branded, they would be considered legal medical devices. Therefore, further clarification is needed to determine if they were supplied by another legal source.
Chien said that the New Taipei City Government Health Department has already investigated some evidence. However, it is still difficult to determine whether the aligners were manufactured by Ounai'en themselves or came from another legal source. The case has been referred to prosecutors for further clarification. (Editor: Hsieh Chia-chen) 1150604
FAQ
What is Ounai'en?
It is a clear aligner brand sold in Taiwan that was found to be operating without a medical device license, leading to a halt in supply.
What should I do if I am a victim?
You can file a complaint with the Consumer Protection Office or apply for a chargeback with your credit card issuer if you paid by card.
What is the impact of this incident?
It challenges the effectiveness of Taiwan's medical device regulations and may erode trust in the clear aligner market.