Regulatory Status of Household Oral Irrigators in China: A Clarification for Global Partners
At Mio, we believe in transparency. As a leading manufacturer of oral irrigators, we often receive questions from international clients regarding the regulatory classification of our products in China.
We want to clearly state:
In China, standard household oral irrigators (water flossers) are NOT classified as medical devices.
This is not just our statement—it is based on official guidance from the Chinese regulatory authority.
Official Evidence from the National Medical Products Administration (NMPA)
On November 25, 2019, the National Institutes for Food and Drug Control (NIFDC) —the professional body under the NMPA—published the "Summary of the Second Batch of Medical Device Product Classification Results in 2019."
In Section IV: Products NOT Regulated as Medical Devices, two items explicitly classify household spray oral irrigators as non‑medical devices:
| Item | Product Description |
|---|---|
| 25 |
Composed of a water pump, water tank, housing, circuit board, and rechargeable battery. Made of polymer materials. Contains no rinsing solution. Operates by pumping water to produce a jet stream that cleans tooth surfaces and areas inaccessible to toothbrushes (such as interdental gaps, pits, and fissures). Intended for daily oral hygiene by the general population.
|
| 26 | Composed of a nozzle, electronic circuitry, pump body, buttons, water tank, and housing. Made of polymer materials. Contains no rinsing solution. Electronically controls the pump to pressurize water, generating thousands of high‑pressure pulsed jets per minute to flush teeth and gaps, removing food debris. Intended for daily removal of deposits on tooth surfaces and interdental spaces by the general population. |
The full official document can be accessed here:
https://www.nifdc.org.cn/nifdc/bshff/ylqxbzhgl/qxxxgk/fljd/20191125095153818.html
What This Means for Our Clients
For customers importing our products into China, or sourcing from us for the Chinese market, no medical device registration (NMPA filing) is required. Our oral irrigators are regulated as standard household electrical appliances under Chinese law.
A Note for International Markets
Regulations vary by country. While our products are non‑medical devices in China, they may be classified differently in your target market—for example, as Class I medical devices in the United States (FDA) or under the MDR in Europe.
✅ We are here to help.
If your country requires medical device registration, certification, or technical documentation for market entry, we are fully prepared to support you. Our team can assist with:
-
Technical files
-
Test reports (CE, FCC, RoHS, IPX7, etc.)
-
Manufacturer declarations
-
Any documentation required for local registration
Partner with Confidence
Whether you need a non‑regulated product for the Chinese market, or a fully documented medical device for global registration, Mio is your trusted partner.
Contact us today to discuss your market requirements—we’ll help you navigate the regulations with confidence.