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 email us.
- Clinical Trial Provisions - SFDA Order No 5 (ENGLISH) - Published January 2004
- Medical Device Classification Provisions - SDA Order No 15 (ENGLISH) - Published April 2000
- Initial Registration of Imported Medical Devices (ENGLISH)
- Re-registration of Imported Devices (ENGLISH)
- Regulations for the Supervision and Administration of Medical Devices (ENGLISH) - Published April 2000
