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Excerpt from the Regulations on the Supervision and Administration of Medical Devices (China)

According to the Regulations on the Supervision and Administration of Medical Devices of the People’s Republic of China, dental handpieces are classified as Class II medical devices. They must be registered or filed with the National Medical Products Administration (NMPA) before entering the market. Manufacturers must ensure compliance with national standard YY/T 0648-2016 (Dental Handpieces) and ISO 7785-1 international requirements.

2025-11-11

According to the Regulations on the Supervision and Administration of Medical Devices of the People’s Republic of China, dental handpieces are classified as Class II medical devices. They must be registered or filed with the National Medical Products Administration (NMPA) before entering the market. Manufacturers must ensure compliance with national standard YY/T 0648-2016 (Dental Handpieces) and ISO 7785-1 international requirements.

Requirements under the EU Medical Device Regulation (MDR 2017/745)

None

Requirements under the EU Medical Device Regulation (MDR 2017/745)

None

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