🇨🇳China Medical Device Regulations

Provisions for Medical Device Registration and Filing

Provisions for standardizing medical device registration and filing acts. Covers Class I filing, Class II/III registration, and technical documentation requirements.

NMPA Laws and Regulations Collection

Comprehensive collection of NMPA laws and regulations including the revised Good Manufacturing Practice for Medical Devices (effective November 2026).

Regulations on Supervision and Administration of Medical Devices

Primary regulation governing medical devices in China. State Council Order No. 739 establishes the legal framework for device classification, registration, manufacturing, and post-market surveillance.

National Medical Products Administration - Medical Devices

Official NMPA portal for medical device news, announcements, and regulatory updates. Covers policy measures to advance drug and medical device regulation reform.

Rules for Classification of Medical Devices

Classification rules dividing medical devices into Class I (low risk), Class II (moderate risk), and Class III (high risk) based on intended purpose, structural characteristics, and use patterns.