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Anti-Snoring Appliances Are Regulated Medical Devices

An anti-snoring appliance (oral appliance, mandibular advancement device, anti-snoring mouthpiece) is an intraoral device used to improve snoring and obstructive sleep apnea. Under Taiwan's Medical Devices Act, any instrument used to diagnose, treat, alleviate or directly prevent human disease is a medical device — and an anti-snoring appliance is one.

A device regulated by law

Manufacturing, importing or selling an anti-snoring appliance requires registration and a medical-device license from Taiwan's Food and Drug Administration (TFDA), supplied by a licensed medical-device vendor. The Medical Devices Act took effect on 1 May 2021, regulating medical devices under dedicated legislation to safeguard the safety, efficacy and quality of products the public uses.

Fabrication and use must follow clinical instruction

The Ministry of Health and Welfare notes that treatment of sleep apnea — including an intraoral appliance, CPAP, or surgery — is mainly decided by a clinician after assessing the patient's condition and sleep status. A legitimate, effective appliance requires a dentist's sleep assessment, oral examination, bite and jaw-position records, custom design and fabrication, with regular follow-up adjustments.

How to identify a legitimate product

Check for a medical-device license number issued by the health authority; ensure it is assessed and custom-made by a dentist rather than a one-size-fits-all off-the-shelf product; be cautious of products claiming efficacy without a device license; and consult a dentist or sleep professional before purchase. Choose an oral appliance (OAT) that holds a TFDA license and is custom-made by a dentist.

Distinguishing from unlicensed retail products

The market and the internet are full of off-the-shelf anti-snoring products, most without a device license, clinical validation, professional assessment or customization. The Academy urges: anti-snoring care is medicine, not product shopping. Choose a legitimate appliance made by a dentist under clinical instruction, with full assessment and follow-up by a professionally trained dental sleep clinician.

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