Preparation of Medical Device Technical Requirements

Key words: Technical Requirements, Data Requirements, Medical Device Registrations, CFDA Regulations, CFDA Approvals
 
The ‘Medical Device Technical Requirements’ compilation should be conformed to CFDA Regulations. And it can also refer to the China National Standard, Industry Standard and Chinese Pharmacopoeia. It is a very important dossier for the medical device registration in China.

CIRS Prepared some ‘Medical Device Technical Requirements’ and ‘Data Requirements’ according to CFDA Regulations and relevant standards.

If you would like to get the Technical Requirements for your medical device products, please find your products on the list of the medical devices technical requirements or make special order. And click here to download the Order Form and follow the procedures below.

 
The List of the Medical Devices Technical Requirements (updated in June 2017)

No. TR for Medical Device Product Product Classification Download
1 Technical Requirements of HA Filler Product Class III CN(Free)
EN(Free)
2 Product List (click for the details)   Order

Why medical device companies need to compile medical device technical requirements

The Medical Device Technical Requirements (TR):
  • The basic requirements for the product research and development
  • The data requirements and basis for the pre-evaluation of product testing
  • The data requirements and basis for the safety-evaluation during the clinical trials
  • The basis of the registration dossiers
  • The basic requirements for technical review
  • The appendix of the medical device registration certificate
  • The basis of the QMS auditing
  • The basis of the product quality control
  • The basis of the product inspected by medical device authorities
  • The judgment basis of registration change (administrative or not )
* If you  have any questions, feel free to contact CIRS at md@cirs-group.com .

 
Active Medical Devices
1 ENT Unit (Ear, Nose & Throat)
2 Cold Light Source
3 Body Composition Analyzer
4 Heavy Duty Battery Powered Equipment
5 Inspire Ice Brackets( Similar product: orthodontic Brackets, Buccal Tubes)
6 Curing Light(LED)
8 Chair of Ear, Nose and Throat
10 Irrigation Unit for nose(Water column type, spray type)
11 Stainer
12 Video EEG Monitoring equipment
13 Temperature Monitoring equipment
14 ECG Monitoring equipment
15 Electrical Coagulation equipment
16 Infrared Imaging System
17 Digital Thermometer
18 Hyperbaric medical treatment chamber
19 X-Ray Medical Imaging System(C arm, DR, breast, interventional procedure, DSA)
20 Automatic chemical luminescence Immunoassay System
21 Colloid gold test paper analyzer
22 Infrared forehead Thermometer(forehead type, ear cavity type)
23 Imaging System for Telescope
24 Ultrasonic Nebuliser
25 Piston Compressor Nebulizer
26 Medical image analyze software
27 Low Frequency Therapy Unit
28 Automated Biochemical Analyzer
29 Automated Blood Coagulation Analyzer
30 Automated Microplate Washer
31 Dental handpieces
32 Medical data transmission
33 Hyperbaric medical treatment chamber
34 The automatically operated complex of graphical prenosological express definition on Biologically Active Zone of human functioning state
35 Medical lasers
36 Cardiology Information System
37 Hydrogen peroxide low temperature plasma sterilizer
38 X,Y-ray Plus Bone Densitometer
39 Electrolyte Analyzer
40 Fetal Monitor
41 Ultrasonic Doppler foetal heartbeat detector
42 Biohazard Safety Cabinet
43 Ophthalmoscope
44 Fundus Camera
45 Suction  Anaesthesia system
46 Women Radio Frequency System
47 Refractor
48 Synoptiscope
49 Ultrasound blood flow imaging and processing system
50 B-Scan Plus
51 Ultrasonometer
52 Corneal Topography System
53 Liver Radiofrequency Ablation Systems
54 Radiofrequency heat equipment
55 Ablation Catheter
56 Insufflation Unit
57 Microkeratome
58 Q switch Nd:YAG Ophthalmic Therapy Laser
59 Capsules Endoscope
60 Ophthalmic A-type Ultrasound measuring equipment
61 Dry chemistry urine analyzer
62 Flow Cytometer
63 Electrolyte Analyzer
64 Dry chemistry analyzer
65 Fully Automated Urine Comprehensive Analyzer
66 Tongue’s information gathering device
67 Chinese Pulse collecting equipment
68 Electronic heating moxibustion device
69 Red light Therapy Unit
Passive Medical Devices
70 Sterile Single-use intravascular catheters
71 Dental Impression Materials
72 Single-use hollow fiber Plasmafilter
73 Guardian Seal
74 Pre-filled Sodium Hyaluronate Syringe
75 Intraocular Lens Placement System
76 Soft Hydrophilic Contact Lenses
77 Single-use enteral nutrition Syringe
78 Dental Zirconium oxide porcelain block
79 Dental porcelain
80 Class I surgical devices
81 Cupping and scraping therapy device
82 Medical bed
83 Cold compress material and devices
84 Medical dressing
85 Single-use medical rubber examination gloves
86 Surgical needle
87 Intra-ocular lens
88 Single-use Sterile Intravenous Catheters
89 Spinal Implant Spinal Fixation System
90 Orthodontic Brackets Adhesive Material
91 Single-use Micropipettes syringe
92 Wound dressing
93 Medium
94 Single-use Chest Drainage Reservoirs
95 Single-use Blood Capillary Sampling
96 Single-use Containers for human venous blood specimen collection
97 Single-use Syringes
98 Single-use Sterile Needles
99 Single-use venous infusion needles
100 Single-use sterile rubber surgical gloves
101 Multipurpose solution
102 Natural latex rubber condoms
103 Single-use Infusion Set (gravity infusion)
104 Dressing
105 Uterine contraceptive
106 Surgical Telescope
107 Rigid gas permeable contact lens
108 Infusion set
In Vitro Diagnostic Reagent
109 In Vitro Diagnostic Reagent(chemiluminescence immunoassay)
110 In Vitro Diagnostic Reagent((Flow cytometry)
111 Bladder cancer cell related chromosome genetic abnormality test kits(FISH)
112 In Vitro Diagnostic Reagent(enzyme linked immunosorbent assay)
113 In Vitro Diagnostic Reagent(Quantitative, qualitative and semi-quantitative of colloidal gold)
114 In Vitro Diagnostic Reagent(PCR method)
 
*CIRS will keep updating the product list. If you cannot find your product on this list, feel free to contact CIRS at md@cirs-group.com for the special order.
Contact Us
CIRS China

Ms. Elaine (Head office)
Tel: +86-571 87206559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mrs.Emily (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Ms. Louise Halpin
Tel: +353 41 9806 916 | Fax: +353 41 9806 999
Email: md@cirs-group.com