Edited by: Department of Medical Devices, State Food and Drug Administration
I. Regulations (Decree of the State Council of the People's Republic of China*** and the State Council of the People's Republic of China)
Regulations on the Supervision and Administration of Medical Devices (No. 276) ......... .............................. .....................(1)
II. Regulations (State (Food) and Drug Administration Decree)
(I) ), State Food and Drug Administration Order
"Regulations on Clinical Trials of Medical Devices" (Bureau Decree No. 5) .................. .............................. ...(7)
Decision of the State Food and Drug Administration on the Revision, Repeal and Retention of Administrative Regulations Involving Administrative Approval
(Bureau Decree No. 8) ............ .............................. .............................. ......(20)
Medical Device Instructions, Labeling and Packaging Marking Regulations (Bureau Decree No. 10) ............ .........(22)
Measures for the Supervision and Administration of Medical Device Manufacturing (Bureau Decree No. 12) ............ .............................. (26)
Measures for the Administration of Medical Device Business Licenses (Bureau Decree No. 15) ..................... ............... (46)
"Measures for the Administration of Medical Device Registration" (Bureau Decree No. 16) ...... .............................. ...............(52)
(ii) State Drug Administration Order
"Rules for Classification of Medical Devices" (Bureau Decree No. 15) ... .............................. .....................(77)
"Regulations for the Approval of New Products of Medical Devices (for Trial Implementation)" (Bureau Decree No. 17) .............................. ......(82)
"Medical Device Manufacturing Enterprises Quality System Assessment Measures" (Bureau Decree No. 22) ............... ...............(84)
"Measures for Supervision and Administration of Single-Use Sterile Medical Devices (Interim)" (Bureau Decree No. 24) ... ..................(90)
Measures for the Administration of Medical Device Standards (for Trial Implementation) (Bureau Decree No. 31) ... .............................. ......(96)
Third, normative documents
Notice on the Implementation of Medical Device Manufacturing, Management and Supervision of Enterprises on Issues Related to the Measures for the Supervision and Management of Medical Devices
State Drug Administration [2000] No. 170 ...... .............................. .............................. (100)
On the reaffirmation of the implementation of medical equipment production and management of enterprises supervision and management of the relevant issues of the notice
Drug supervision and management [2000] No. 18 ............... .............................. ........................... (101)
On medical equipment supervision and law enforcement in the implementation of the "Drug Supervision Administrative Punishment Procedures" notice
State Drug Administration Equipment [2000] No. 312 .................. .............................. ..................... (102)
Notice on the supervision and management of medical sanitary materials and dressings products
State Drug Administration Equipment [2001] No. 16 ........................ .............................. .................. (125)
On the issuance of "imported medical equipment registration and testing provisions of the notice"
State Drug Administration Equipment [2001] No. No. 130 ........................... .............................. ............(125)
On the transmittal of the "Supreme People's Court, the Supreme People's Procuratorate on the handling of the production, sale of counterfeit and shoddy goods in criminal cases of specific application of the law on a number of issues of the Interpretation of the Circular State Drug Supervision and Regulation of Equipment [2001] 190 No. .................. (128)
Notice on the import of medical devices, the territory of the third class of medical devices registration of a number of additional instructions
State drug Supervision of equipment [2001] No. 478 ........................... .............................. ............(131)
Approval Reply on the Issue of Whether the Manufacturing and Operating Enterprises of Class I Medical Devices Can Directly Apply for the Business License
State Pharmaceutical Supervision and Regulation of Medicines [2001]No.532 .............................. .............................. .........(134)
Announcement on the Prohibition of the Import and Sale of Medical Devices Containing Bovine and Sheep Tissue Cells from Countries or Regions Experiencing Mad Cow Disease State Pharmaceutical Supervision and Regulation of Devices [2002] No. 112 ...... .............................. .....................(134)
Notice on the Issuance of Supplementary Provisions for Registration of Medical Devices (I)
State Drug Administration [2002] No. 259 ........................ .............................. ............ (135)
On the issuance of "medical device manufacturers daily supervision and scheduling management regulations (for trial implementation)" notice
State Drug Administration [2003] No. 13 ... .............................. .............................. .........(137)
Notice on the Issuance of the Administrative Provisions of the National Medical Device Evaluation Expert Pool (for Trial Implementation)
State Pharmaceutical Supervision and Apparatus [2003] No. 44 ...... .............................. .............................. ......(140)
On the issuance of the "Medical Device Registration Supplementary Provisions (II) Notice"
State Drug Administration [2003] No. 119 ......... .............................. .............................. (142)
On the issuance of "medical device testing organizations accreditation measures (for trial implementation)" of the notice
State Drug Administration [2003] No. 125 ............... .............................. ........................(150)
Registration of In Vitro Diagnostic Reagents Classified Under Medical Device Management Diagnostic Reagents Registration Notice
SDFM [2003] No. 140 ..................... .............................. ...............(159)
Notice on Simulation-type Sexual Aids Not Being Managed as Medical Devices
SDFM[2003]No.220 .............................. .............................. ......(160)
Notice on the Issuance of Interim Provisions on the Registration of Customized Dentures
Sate Food and Drug Administration and Supervision of Measures [2003] No. 365 ............ .............................. ........................(160)
On the issuance of medical device products export sales Certificate on the Management Regulations
Sate Food and Drug Administration Measures [2004] No. 24 ..................... .............................. ..................(162)
Notice on the Catalog of National Drug Clinical Research Bases
Sate Food and Drug Administration and Supervision of Machinery[2004]No.97 .............................. .............................. ......(171)
Notice on the Implementation of the "Measures for the Supervision and Administration of the Production of Medical Devices" and Related Issues
Sate Food and Drug Administration and Supervision of Machinery [2004] No. 498 ......... .............................. ........................(177)
On the implementation of the "Medical Device Registration Management Measures" on matters related to the notice
Sate Food and Drug Administration Measures [2004] No. 499 ..................... .............................. ............ (180)
Notice on the Issuance of the "Medical Device Manufacturer License" Approval Practice
Sate Food and Drug Administration and Machinery [2004] No. 521 ... .............................. .............................. ... (181)
On the issuance of "the territory of the first class of medical devices registration and approval of the operating norms (for trial implementation)" and "the territory of the second class of medical devices registration and approval of the operating norms (for trial implementation)" Notice State Food and Drug Administration Measures [2005] No. 73 ...... ...............(198)
Circular on "Code of Practice for Registration and Approval of Class III and Overseas Medical Devices within the Territory (Trial Implementation)
SDFM [2005]No.75 .............................. .............................. ......(210)
Circular on the Issuance of the Acceptance Standard for Registration Declaration Information of Class III, Overseas Medical Devices within the Territory
Sate Food and Drug Administration and Supervision of Machinery [2005] No. 111 ......... .............................. .............................. (212)
Notice on the Release of the First Catalog of Medical Devices Prohibited from Commissioned Manufacturing
Sate Food and Drug Administration and Supervision of Machinery [2005] No. 166 ............... .............................. .....................(226)
On the use of the new "overseas medical device quality management system on-site review report" of the Notice
Sate Food and Drug Administration and Supervision of Machinery [2005] No. 185 ........................ .............................. ............(226)
Scope of Testing Centers
Notice on the Accreditation of China Institute for the Control of Pharmaceutical and Biological Products (ICCPBP) for Testing of Prosthetic Heart Valves and Other Products and Items
Sate Food and Drug Administration and Mechanical [ 2005]No.3 ............ 2005]No.3 ........................... .............................. ............(240)
Notice on the Accreditation of Shanghai Medical Devices Inspection Institute for Testing of Implantable Cardiac Defibrillators and Other Products and Items
SHDFAME [2004]No.492 .............................. .............................. ......(251)
Notice on the Accreditation of Beijing Medical Devices Inspection Institute for Testing of Implantable Cardiac Pacemakers and Other Products and Items
SHDFS [2004]No.553 ...... .............................. .............................. (267)
Notice on the Accreditation of Liaoning Medical Device Product Quality Supervision and Inspection Institute for Testing of Medical Diagnostic X-Ray Machines and Other Products and Items State Food and Drug Administration Mech[2004]No.384 ............ .............................. ............(283)
Notice on the Accreditation of Tianjin Quality Supervision and Inspection Center for Medical Devices for the Testing of Hip Prostheses and Other Products and Items
SHDFS [2004]No.469 .............................. .............................. ......(289)
Notice on the Accreditation of Zhejiang Medical Device Inspection Institute for Testing of Carbon Dioxide Laser Treatment Machines and Other Products and Items
SDFM [2004]No.485 ...... .............................. .............................. (301)
Notice on the Accreditation of Guangdong Medical Device Quality Inspection Center for Testing of Artificial Heart-Lung Machine and Other Medical Device Products
SHDFS [2004]No.245 ............ .............................. ........................(311)
On the recognition of the National Wuhan Ultrasound Instrument Quality Supervision and Testing Center of B-mode Ultrasonic Diagnostic Equipment and Project Testing Qualification Notice
Sate Food and Drug Administration Measures [2004] No. 606 .................. .............................. ..................(318)
Notice on the Accreditation of Shandong Medical Devices Product Quality Inspection Center for Testing of Disposable Infusion Devices and Other Products and Items < /p>
State Food and Drug Administration Measures [2004] No. 390
..................... .............................. .........(321)
Medical Device Product Classification Definition
Notice on the Issuance of the Medical Device Classification Catalog
State Pharmaceutical Supervision and Regulation of Machinery [2002] No. 302 ... .............................. .............................. ......(331)
Announcement on the Implementation of Classification and Management of In Vitro Diagnostic Reagents
State Pharmaceutical Supervision and Administration [2002]No.324 ............ .............................. ........................... (368)
Approval Reply on Relevant Issues of the 2002 Edition of the Classification Catalog of Medical Devices
State Pharmaceutical Supervision and Regulation [2002] No. 410 .................. .............................. .....................(369)
Notice on the Problems of Defining the Classification of Some Medical Device Products
State Drug Administration [2003] No. 98 ........................... .............................. ............(370)
Notice on Classification Definition of Some Products
State Food and Drug Administration [2003]No.95 ...... .............................. .............................. ...(371)
Notice on the Definition of Classification of Some Products
State Food and Drug Administration and Machinery [2003]No.182 ............... .............................. .....................(371)
Notice on Classification Definition of Oxygen Flow Meter and Other Products
State Food and Drug Supervision and Measurement [2003] No. 310 ........................ .............................. ............(372)
Notice on the Classification and Definition of Desensitizing Gel and Other Products
State Food and Drug Administration and Supervision of Machinery[2003]No.333 ...... .............................. .............................. (374)
Notice on the Classification and Definition of Nanosilver Gynecological Antibacterial Apparatus and Other Products
SHDFA [2004]No.53 ............... .............................. ........................(375)
On Urinary Sediment Counting Plate and other 37 products Classification Definition Notice
State Food and Drug Administration Measures [2004] No. 84 ..................... .............................. ..................(377)
Notice on Classification Definition of Bio-hemostatic Membrane and Other Products
SDFM[2004]No.204 .............................. .............................. ......(379)
Notice on Classification Definition of Gingivitis Rinser and Other Products
SDFM[2004]No.321 ............ .............................. ........................(380)
On the stop snoring device and other products categorization definition of the Notice
State Food and Drug Administration Measures [2004] No. 331 ........................ .............................. ............(384)
Notice on the Classification and Definition of Products such as Intestinal Hydrotherapy Machines
SDFM[2004]No.433 ...... .............................. .............................. (385)
Notice on the Classification and Definition of Femoral Artery Hemostatic Compressor and Other Products
SDFM [2004]No.471 ............... .............................. .....................(387)
Notice on the Classification and Definition of Cerebral Stereotactic Membrane and Other Products
State Food and Drug Administration Measures [2004] No. 605 ........................ .............................. ............(388)
Notice on the Classification and Definition of Medical Nebulizers and Other Products
Sate Food and Drug Administration Measures [2004]No.616 ...... .............................. .............................. (388)
Notice on the Classification and Definition of Disposable Ophthalmic Surgical Knives and Other Products
SHDFS [2005]No.60 ............... .............................. .....................(390)
Notice on Classification Definition of Imaging IP Boards and Other Products
State Food and Drug Administration Mech[2005]No.118 ........................ .............................. ............(392)
Notice on the Classification and Definition of Oral Digital Observation Instrument and Other Products
SHDFS [2005]No.154 ... .............................. .............................. ...(393)