Registration Measures for the Administration of Registration of Medical Devices
Imported medical device registration and testing provisions
Domestic Class I medical device registration and approval of the operating norms
Domestic Class II medical device registration and approval of the operating norms (Trial)
Medical device registration product Standards for the preparation of norms
Medical device new product approval regulations (for trial implementation) Bureau Decree No. 17
Production supervision and management:
Medical device production supervision and management measures Bureau Decree No. 12
Medical device production quality system assessment measures Bureau Decree No. 22
Medical device production routine supervision and management regulations of the state food and drug supervision and management of equipment [ 2006] No. 19
Medical device production supervision and management provisions of the State Food and Drug Administration [ 2006] No. 19
Measures for Supervision and Administration of Medical Device Business Enterprises Bureau Decree No.19
Medical Device Manufacturing Quality Management Standard (for Trial Implementation) State Food and Drug Administration Measures [2009]833
Medical Device Manufacturing Quality Management Standard Inspection Management Methods (for Trial Implementation) State Food and Drug Administration Measures [2009]834
Medical Device Manufacturing Quality Management Standards for Sterile Medical Devices Implementation Rules (Trial) State Food and Drug Administration Measures [2009] No. 835
Medical Device Production Quality Management Standards for Implantable Medical Devices (Trial)
Packaging Medical device instructions, labels and packaging marking regulations July 8, 2004 Bureau Decree No. 10
Medical device instruction manuals management requirements Bureau Decree No. 30 of January 4, 2002
Advertising Medical Device Advertising Review Measures Bureau of Industry and Commerce and the State Administration of Pharmaceutical Affairs Affairs Meeting No. 24
Medical Device Advertising Review Standards March 3, 1995 Bureau of Industry and Commerce Decree No. 23
Classification of Medical Devices Classification Rules April 5, 2000 Bureau Decree No. 15
Medical Device Classification Directory State Drug Administration Equipment [2002] No. 302
State Key Regulatory Medical Device Directory State Drug Administration Equipment [2002] No. 153
Standards Medical Device Standards Management (Trial) Bureau Decree No. 31
Testing Clinical Trials of Medical Devices Bureau Decree No. 5
Designated Measures for the Supervision and Administration of Single-Use Sterile Medical Devices (Interim) Bureau Decree No. 24
Single-Use Medical Device Supervision and Administration Measures (Tentative) Bureau of Industry and Commerce. Provisional) Bureau Decree No. 24
Medical Device Biological Evaluation and Review Guidelines State Food and Drug Administration Measures [2007] No. 345