1. Basic Laws and Regulations
Regulations on Supervision and Administration of Medical Devices (State Council Decree 680) 2017
2. Review and Approval Regulations
• Measures for the Administration of Registration of Medical Devices - CFDA Order No.4 2014
• Measures for the Administration of Registration of In-Vitro Diagnostic Reagents - CFDA Order No.5 2014
• Announcement on Classification Catalogue for Medical Devices (No.104 2014)
• Announcement on Requirements for Registration Application Data of Medical Devices and the Format of Approval and Certification Documents - No.43 2014
• Announcement on Requirements for Registration Application Data of In Vitro Diagnostic Reagents and the Format of Approval and Certification Documents
(No.44 2014)
