Preparation of Medical Device Technical Requirements - Regulatory News - Medical Devices

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 .

Product List

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.

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