China Medical Device Regulations

We have assembled the following documents as a service to the medical device community. Most documents were published by the State Food and Drug Administration (SFDA) and are in PDF format. If you find a newer version of a document or one that should be included, please marketing [at] emergogroup [dot] com (email us).

Major Regulations

• Regulations for the Supervision and Administration of Medical Devices

General Guidance Documents

• Provisions for the Instructions, Labels and Package of Medical Devices - SFDA Order No 10
• Medical Device Classification Provisions - SDA Order No 15
• Initial Registration of Imported Medical Devices
• Re-registration of Imported Devices

Specific Guidance Documents

• Clinical Trial Provisions - SFDA Order No 5