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 Decree
"Regulations on Clinical Trials of Medical Devices" (Bureau Decree No. 5 ) ........................... ........................(2)
"State Food and Drug Administration on the regulations involving the Administrative Approval of Administrative Regulations Modified, Abolished, Retained Decision"
(Bureau Decree No. 8) ..................... .............................. .............................. ......(3)
"Medical Device Instructions, Labeling and Packaging Marking Regulations" (Bureau Decree No. 10) ............... .........(4)
Measures for the Supervision and Administration of Medical Device Manufacturing (Bureau Decree No. 12) ............ .............................. ...(5)
Measures for the Administration of Medical Device Business Licenses (Bureau Decree No. 15) .................. ..................... (6)
Measures for the Administration of Medical Device Registration (Bureau Decree No. 16) .............................. ........................ (7)
(ii), the State Drug Administration Order
"Medical Device Classification Rules" (Bureau Decree No. 15) ........................ .............................. ...(8)
"Regulations for the Approval of New Products of Medical Devices (for Trial Implementation)" (Bureau Decree No. 17) .................. ..................(9)
Medical Device Manufacturing Enterprises Quality System Assessment Measures (Bureau Decree No. 22) ... ...........................(11)
The Measures for the Supervision and Administration of Single-Use Sterile Medical Devices (Interim)" (Bureau Decree No. 24) .....................(12)
< p>Measures for the Administration of Medical Device Standards (for Trial Implementation) (Bureau Decree No. 31) ........................ ............... (13)Third, normative documents
Notice on the implementation of medical device production, management and supervision of enterprises on issues related to the supervision and management measures
State Drug Administration [ 2000]170 ........................... .............................. ......... (14)
Notice on the Reaffirmation of Issues Related to the Implementation of the Measures for the Supervision and Management of Medical Device Manufacturing and Operating Enterprises
Drug Administration Equipment [ 2000 ] No. 18 ...... .............................. .............................. ...... (15)
Notice on the implementation of "Drug Supervision Administrative Punishment Procedures" in the supervision and enforcement of medical devices
State Drug Administration [2000] No. 312 ......... .............................. .............................. (16)
Notice on the supervision and management of medical sanitary materials and dressings products
State Drug Administration [2001] No. 16 .................. .............................. ........................(17)
On the issuance of the "imported medical devices registered test Provisions of the Notice
Sate Drug Administration [2001] No. 130 ..................... .............................. ..................(18)
On the transmittal of the "Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Specific Application of Laws in the Handling of Criminal Cases Involving the Production and Sale of Counterfeit and Shoddy Goods Interpretation of a number of legal issues" of the notice of the State Drug Administration [2001] No. 190 .................. (19)
On the import of medical devices, the territory of the third type of Notice on Imported Medical Devices, Domestic Class III Medical Devices Registration Some Supplementary Explanations
State Drug Administration [2001] No. 478 ..................... .............................. ..................(20)
On the first class of medical equipment production, business enterprises can directly apply for the "business license" of the issue of the approval of the reply
State Drug Administration [2001] No. 532 ........................ .............................. ...............(21)
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)
On the issuance of medical device registration supplementary provisions (I) of the notice
State Drug Administration Equipment [2002] No. 259 .................. .............................. .................. (22)
On the issuance of "medical device manufacturers daily supervision and scheduling management regulations (for trial implementation)" notice
State drug Supervision of equipment [2003] No. 13 ........................... .............................. ...............(23)
On the issuance of the "national medical device review expert pool management regulations (for trial implementation)" notice
State Drug Supervision and Apparatus [2003] No. 44 .............................. .............................. ............(24)
Notice on the Issuance of Supplementary Provisions on Registration of Medical Devices (II)
State Drug Administration [2003]No.119 ... .............................. .............................. ......(25)
Notice on the Issuance of Measures for the Accreditation of Medical Device Testing Organizations (for Trial Implementation)
State Pharmaceutical Supervision and Regulation of Machinery [2003]No.125 ......... .............................. .............................. (26)
Notice on the Registration of In Vitro Diagnostic Reagents Under the Management of Medical Devices
Sate Food and Drug Administration [2003] No. 140 ............... .............................. .....................(27)
Notice on Simulation-type Sexual Aids Not to be Managed as Medical Devices
Sate Food and Drug Administration [2003] No. 140 ..................... >State Food and Drug Administration Measures [2003] No. 220 ........................ .............................. ............(28)
Notice on the Issuance of Interim Provisions on the Registration of Customized Dentures
Sate Food and Drug Administration Measures [2003] No. 365 ...... .............................. .............................. (29)
Administrative Provisions on Issuance of Export Sales Certificates for Medical Device Products
Sate Food and Drug Administration and Supervision of Machinery [2004] No. 24 ............... .............................. ........................(30)
On the "National Drug Clinical Research Base Directory
Notice on "National Drug Clinical Research Base Catalog"
Sate Food and Drug Administration and Supervision of Machinery [2004] No. 97 ........................ .............................. ............(31)
Notice on the Implementation of the "Measures for the Supervision and Administration of the Manufacture of Medical Devices" and Related Issues
Sate Food and Drug Administration and Machinery [2004] No. 498 ... .............................. .............................. (32)
Notice on Matters Relating to the Implementation of the Measures for the Administration of Registration of Medical Devices
Sate Food and Drug Administration [2004] No. 499 ............... .............................. .................. (33)
Notice on the Issuance of "Medical Device Manufacturing Enterprise License" Approval Practice
Sate Food and Drug Administration Measures [ 2004]No.521 ........................... .............................. ......... (34)
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)" of the notice of the state food and drug supervision and treatment [2005] No. 73 .....................(198)
On the "Code of Practice for Registration and Approval of Class III and Overseas Medical Devices within the Territory (Trial Implementation)
Notice of the "State Food and Drug Administration Measures [2005] No. 75 ........................ .............................. ............(35)
Circular on the Issuance of the Acceptance Standard for the Registration and Declaration of Medical Devices within the Territory of the Third Class and Overseas
Sate Food and Drug Administration and Machinery [2005] No. 111... .............................. .............................. ......(36)
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 ......... .............................. ...........................(37)
Notice on the The use of the new "overseas medical device quality management system on-site review report" notice
Sate Food and Drug Administration and Machinery [2005] No. 185 .................. .............................. ..................(38)
Scope of Inspection Undertaken by Testing Centers
Notice on the Accreditation of Testing Qualifications for Prosthetic Heart Valves and Other Products and Items by China National Institute for Testing and Certification of Pharmaceutical and Biological Products (CNIB) .............................. ..................(39)
Notice on the Accreditation of Shanghai Medical Devices Inspection Institute for Testing of Implantable Cardiac Starters and Other Products and Programs
State Food and Drug Administration Measures [2004] No. 492 ........................ .............................. ............(40)
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 .............................. .............................. ......(41)
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 ...... .............................. ..................(42)
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
< p>State Food and Drug Administration Mech[2004]No.469 ........................ .............................. ............(43)Notice on the Accreditation of Zhejiang Medical Devices Inspection Institute for Testing of Carbon Dioxide Laser Therapy Machine and Other Products and Items
SHDFS [2004]No.485 .............................. .............................. ......(44)
Notice on the Accreditation of Guangdong Medical Devices Quality Testing Center for the Testing of Artificial Heart-Lung Machine and Other Medical Device Products
SHDFS [2004]No.245 ...... .............................. .............................. (45)
Notice on the Accreditation of the National Wuhan Ultrasonic Instrument Quality Supervision and Testing Center for the Testing of Diagnostic B-type Ultrasound Equipment and Items
SDFM [2004]No.606 ............ .............................. ........................(46)
On the recognition of Shandong Province Medical Device Product Quality Inspection Center of Shandong Province on single-use infusion sets and other products and project testing notice
Sate Food and Drug Administration Measures [2004] No. 390
............... .............................. ...............(47)
Medical Device Product Classification Definition
Notice on the Issuance of the Medical Device Classification Catalog
State Pharmaceutical Supervision and Regulation of Machinery [2002]302 No. ........................... .............................. ............(48)
Announcement on the Implementation of Classification and Management of In Vitro Diagnostic Reagents
State Drug Administration [2002]No.324 ...... .............................. .............................. .............................. ...........................(50)
Approval on Part of the medical device product classification definition of the problem of the notice
State Drug Administration Equipment [2003] No. 98 ..................... .............................. ..................(51)
Notice on the Definition of Classification of Some Products
State Food and Drug Administration [2003] No. 95 .............................. .............................. .........(52)
Notice on the Definition of Classification of Some Products
Sate Food and Drug Administration and Machinery [2003] No. 182 ......... .............................. ...........................(53)
Notice on the Notification on the Classification Definition of Oxygen Flow Meter and Other Products
SHDFS [2003] No. 310 ..................... .............................. ...............(54)
Notice on the Classification and Definition of Desensitizing Gel and Other Products
SDFM [2003]No.333 ... .............................. .............................. ...(55)
Notice on the Classification and Definition of Nanosilver Gynecological Antibacterial Apparatus and Other Products
SHDFA [2004]No.53 ............... .............................. ........................(56)
On the urine sediment counting plate and other 37 products Classification Definition Notice
State Food and Drug Administration Measures [2004] No. 84 ..................... .............................. ..................(57)
Notice on Classification Definition of Bio-hemostatic Membrane and Other Products
SDFM[2004]No.204 .............................. .............................. ......(58)
Notice on the Classification and Definition of Gingivitis Rinser and Other Products
SDFM[2004]No.321 ............ .............................. ........................(59)
Notice on the Classification Definition of Stop Snoring Apparatus and Other Products
State Food and Drug Administration Measures [2004] No. 331 ........................ .............................. ............(60)
Notice on the Classification and Definition of Intestinal Hydrotherapy Machines and Other Products
SDFM[2004]No.433 ...... .............................. .............................. (61)
Notice on the Classification and Definition of Femoral Artery Hemostatic Compressor and Other Products
SDFM [2004]No.471 ............... .............................. .....................(62)
Notice on the Classification and Definition of Cerebral Stereotactic Membrane and Other Products
State Food and Drug Administration Measures [2004] No. 605 ........................ .............................. ............(63)
Notice on the Classification and Definition of Medical Nebulizers and Other Products
SHDFS [2004]No.616 ...... .............................. .............................. (64)
Notice on the Classification and Definition of Disposable Ophthalmic Surgical Knives and Other Products
SHDFS [2005]No.60 ............... .............................. .....................(65)
Notice on the Classification and Definition of Imaging IP Boards and Other Products
State Food and Drug Administration 械[2005]118号 ........................... .............................. .........(66)
Notice on the Classification and Definition of Oral Digital Observation Instrument and Other Products
SDFM[2005]No.154 ......... .............................. ...........................(67)