Historically Most! 33 Medical Devices Guidelines Coming

  • 2017-03-30

After 15 guidelines were implemented on March 28, the CMDE issued 33 guidelines for technical review of registrations on March 29, including the artificial cervical disc prosthesis. The details were as followings :

1

Technical Review Guidelines for Registration of Artificial Cervical Disc Prosthesis (2017 No. 23)

2

Technical Review Guidelines for Registration of Surgical Electrodes (Revised version 2017) (2017 No.41)

3

Technical Review Guidelines for Product Registration of Polyurethane Foam Dressings (2017 No.44)

4

Technical Review Guidelines for Product Registration of Dental Fiber Posts (2017 No.44)

5

Technical Review Guidelines for Drug Abuse Assay Reagent (2014 No.2)

6

Technical Review Guidelines for Assay Reagent of Gene Mutation Associated with Personalized Tumor Treatment (2014 No.2)

7

Technical Review Guidelines for Assay Reagent of Affinity Associated with Toxoplasma, Rubella Virus, Cytomegalovirus and Herpes Simplex Virus Antibodies and Immunoglobulin G Antibody (2014 No.2)

8

Technical Review Guidelines for Registration of Medical Magnetic Resonance Imaging (MRI) (2014 No.2)

9

Technical Review Guidelines for Product Registration of Metal Plate Internal Fixation Systems (2014 No.6)

10

Technical Review Guidelines for Product Registration of Hemodialysis Concentrates (2014 No.6)

11

Technical Review Guidelines for Product Registration of Disposable Lucifugal Infusion Sets (2014 No.6)

12

Technical Review Guidelines for Product Registration of Disposable Plasma Apheresis Sets (2014 No.6)

13

Technical Review Guidelines for Product Registration of Resin-based Dental Filling Materials (2014 No.6)

14

Technical Review Guidelines for Product Registration of Cardiac Radiofrequency Ablation Catheters (2014 No.5)

15

Technical Review Guidelines for Product Registration of Disposable Skin Staplers (2014 No.7)

16

Technical Review Guidelines for Product Registration of Disposable Surgical Laryngeal Masks (2014 No.7)

17

Technical Review Guidelines for Product Registration of Umbilicus Protective Belts (2014 No.7)

18

Technical Review Guidelines for Product Registration of Disposable Drainage Tubes (2014 No.7)

19

Technical Review Guidelines for Product Registration of Surgical Masks (2014 No.7)

20

Technical Review Guidelines for Product Registration of Alkaline Phosphatase Assay Kits (2014 No.7)

21

Technical Review Guidelines for Product Registration of Ischemia-modified Albumin Assay Reagent (2014 No.7)

22

Technical Review Guidelines for Product Registration of Creatine Kinase Assay Kits (2014 No.7)

23

Technical Review Guidelines for Product Registration of C-reactive Protein Quantitative Assay Kits (2014 No.7)

24

Technical Review Guidelines for Product Registration of Dental Handpieces (2014 No.7)

25

Technical Review Guidelines for Product Registration of Pulse Oximeters (2014 No.7)

26

Technical Review Guidelines for Product Registration of Clinical Electronic Thermometers (2014 No.7)

27

Technical Review Guidelines for Product Registration of Electric Apparatus for Gastric Lavage (2014 No.7)

28

Technical Review Guidelines for Product Registration of Temperature Control Blanket for Medical Use (2014 No.7)

29

Technical Review Guidelines for Product Registration of Assay Reagent for Flow Cytometers (2013 No.3)

30

Technical Review Guidelines for Clinical Trial Registration of HIV Assay Reagent (2013 No.3)

31

Technical Review Guidelines for Product Registration of Qualitative Assay Reagent for Pathogen-specific Immunoglobulin M (2013 No.3)

32

Technical Review Guidelines for Product Registration of Quantitative Assay Reagent for Hepatitis B Virus Deoxyribonucleic Acid (2013 No.3)

33

Technical Review Guidelines for Product Registration of Hernia Repair Patches (2013 No.7)


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