The Technical Guideline for Registration of Medical Devices is an existing interpretation of regulator on policies and issues, a normative guidance document on registration application for medical device registration applicants and for technical review of medical device registration, a valuable data and important guidance basis for the work of review department, and an important basis to standardize the development, production, marketing of products and preparation of declaration materials.
Five months passed in 2017, out of 35 guidelines issued by the CFDA, 33 are for technical review of registration, 1 for technical review of clinical evaluation and 1 for clinical trial. From the product category, the 35 guidelines cover 5 IVD product types, 9 passive product types and 21 active product types. The information summary of the 35 guidelines collected by TACRO is as shown in the table below:
1) Technical Review Guidelines for Registration of Full-automatic Blood Group Analyzer
2) Technical Review Guidelines for Antihuman Globulin Assay Reagent
3) Technical Review Guidelines for Registration of ABO, RhD Antigen Test Kit (column agglutination)
4) Technical Review Guidelines for Registration of Ultrasonic Doppler Fetus Cardiotachometer
5) Technical Review Guidelines for Registration of Electric Traction System (Revised edition 2017)
6) Technical Review Guidelines for Registration of Electric Operating Table (Revised edition 2017)
7) Technical Review Guidelines for Registration of Imaging Ultrasonic Diagnostic Equipment (Class II)
8) Technical Review Guidelines for Assay Kit of hEGF Receptor 2 Gene Amplification (FISH)
9) Technical Review Guidelines for Registration of Fetus Chromosomal Aneuploid (T21, T18, T13) Assay Kits (high-throughput sequencing)
10) Technical Review Guidelines for Registration of Anastomat for Endoscope
11) Technical Review Guidelines for Product Registration of Dental Fiber Posts
12) Technical Review Guidelines for Product Registration of Polyurethane Foam Dressings
13) Technical Review Guidelines for Registration of Injection Pump (Revised edition 2017)
14) Technical Review Guidelines for Registration of Surgical Electrodes (Revised edition 2017)
15) Technical Review Guidelines for Registration of Clinical Electronic Thermometers (revised edition 2017)
16) Technical Review Guidelines for Registration of Semiconductor Laser Treatment Machine (Class II) (Revised edition 2017)
17) Technical Review Guidelines for Registration of Visible Spectrum Therapeutic Apparatus
18) Technical Guidelines for Registration of Fiberscope (Class II) (Revised edition 2017)
19) Technical Review Guidelines for Registration of Rigid Endoscope (Class II) (Revised edition 2017)
20) Technical Review Guidelines for Registration of Artificial Cochlear Implantation System
21) Technical Review Guidelines for Registration of Electric Ward Bed (Revised edition 2017)
22) Technical Review Guidelines for Registration of Laparoscopic Surgical Instrument
23) Technical Review Guidelines for Registration of Surgical Shadowless Lamp
24) Technical Review Guidelines for Registration of MTBC Drug Resistance Gene Mutation Assay Reagent
25) Technical Review Guidelines for Registration of Artificial Cervical Disc Prosthesis
26) Technical Review Guidelines for Registration of Hip Joint Prosthesis System
27) Technical Review Guidelines for Registration of Calcium Phosphorus/silicone bone filling materials
28) Technical Review Guidelines for Product Registration of CVC
29) Technical Review Guidelines for Registration of Stocking Medical Pressure Belt
30) Technical Review Guidelines for Registration of Medical Device Network Security
31) Technical Review Guidelines for Clinical Evaluation of Medical Magnetic Resonance Imaging
32) Technical Review Guidelines for Registration of Mouth Maxillofacial Taper CT device
33) Technical Review Guidelines for Registration of In Vitro Defibrillation Product
34) Technical Review Guidelines for Registration of Light Curing Machine
35) Guidelines for Clinical Trial of Artificial Cochlear Implantation System