China Medical Device Regulations

We have assembled the public documents below as a service to the medical device community. Although we do our best to ensure that these documents are the latest versions, things change. If you would like to suggest a document for inclusion or we have included an outdated version, please let us know. All documents were published by the State Food and Drug Administration (SFDA) and are in PDF format unless otherwise noted.

• Clinical Trial Provisions
• Device Classification Provisions
• Initial Registration of Devices
• Re-registration of Imported Devices
• Regulations for the Supervision and Administration of Medical Devices