Your Helpful Statistics of Medical Device Industry in 2014 - Regulatory News - Medical Devices

Chinese medical device market has attracted over 40.87 billion dollars investment and became the second largest market in the world. Many multinational companies have optimized their market strategy and regulatory compliance strategy to expand their business in China.
According to the official statistics from Chinese medical device authorities in 2014, the medical device industry is still growing with high speed and it will keep the long-term higher Compound Annual Grow Rate in the future.
These statistics are issued by Chinese governments and gathered and prepared by CIRS Medical Device RA Team. The Statistics of medical device industry in 2014 can be found below:

1. Submission and Evaluation (2014)

No.	Item	Statistics
1	Registration Submission	9,679
2	Evaluated submission (Qualified)	9,196
3	Supplementation notice issued	10,800

2. Registration Certificates and Registrants (Total )

No.	Item		Statistics	Distribution
4	Imported medical device	Registration Certificates	34,650
5	Imported medical device	Legal Representative	2,447
6	Domestic medical device	Registration Certificates	93,582
7	Domestic medical device	Legal Representative	14,723

3. Medical device market

No.	Item	Statistics	Distribution
8	Total Market	USD 40.87 billion
9	Export	USD 20.023 billion
10	Import	USD 15.771 billion

4. Medical & Hygiene Institution

No.	Item	Statistics	Distribution
11	Hospitals	25,865
12	Township hospitals	36,899
13	Community Health Service ( CHS ) centers	34,264
14	Clinics	188,415
15	The village clinics	646,044
16	Centers for Diseases Control (CDC) and Prevention	3,491
17	Sanitary supervision institutes	2,975
18	Others (healthcare service)	44,490
19	Total	982,443

5. Penalty of illegal advertisement

No.	Item	Statistics
20	Illegal drug advertisement	264,159
21	Illegal medical device advertisement	21,639
22	Illegal healthy food advertisement	48481

6. Adverse event & Recall

No.	Item	Statistics
23	Recall	81
24	Adverse events (2013 total)	238,650
25	Class III medical devices	105,032
26	Class II medical devices	80,394
27	Class I medical devices	48,254
29	Others	4,970

7. Top 10 list

No.	Number of registration certificate (by manufacturing area)		Number of registration certificate (by classified category)
No.	Domestic (Province)	Imported(Country)	Domestic	Imported
1	Jiangsu	USA	6840 (IVD)	6840 (IVD)
2	Shanghai	Germany	6864	6822
3	Guangdong	Japan	6866	6846
4	Beijing	UK	6826	6866
5	Zhejiang	France	6863	6863
6	Shandong	Korea	6854	6821
7	Henan	Switzerland	6810	6877
8	Hubei	Ireland	6856	6854
9	Hebei	Sweden	6846	6810
10	Tianjin	Finland	6822	6864

Appendix. Catalogue of Medical device classified category

Code	Category Name	Related Products(Partial)	Latest update
6801	Basic surgical instruments	Vessel dilator, Scalp　clip　System, dermal curette, dissecting forceps, Dissector	2002
6802	Microsurgical instrument	Micro-needle Holders, Micro-scissors, surgical rinsing needle , Micro-throat hook , Micro retractor	2002
6803	Neurosurgery Surgical Instruments	aneurysm clips, hand cranial drill, brain spatula, Brain curette, Nerve Hook	2002
6804	Ophthalmic operation instruments	Ophthalmic forceps, eye speculum, Disposable ophthalmic surgical knife, Vitreous cutter, chute blades	2002
6805	Otorhinolaryngologic Operation Instruments	Nose Scissors, Rhinoscope, Nasal cavity retractor, Ear probe, aural clamp	2002
6806	Dental surgical instruments	Gums separator, dental chisel, amalgam carrier, amalgam carver, nerve broach holders	2002
6807	Thoracic and Cardiovascular Surgical Instruments	thoracic hemostatic forceps, lung grasping forceps, mitral valve clip system accessories, Rib retractor, Valve surgery forceps	2002
6808	Abdominal Surgery Instruments	Kent Retractors, Extraction Balloon, Gastric banding surgery closer, Intestinal clamp	2002
6809	Urinary anorectal surgical instruments	Bladder neck clamp, anoscope, Urethral dilator, Renal pedicle clamp, small knife in anorectal surgery, Nano circumcision device	2002
6810	Orthopedic surgery (orthopedic) surgical instruments	Plaster scissors, Bone Saw, Tibia cutter, Bone holder forceps, Skeletal traction pin	2002
6812	Obstetrics and gynecology surgical instruments	Caesarean scissors, umbilical cord scissors, Vaginal drag hook, Cesarean incision forceps, Intrauterine doctor blade	2002
6813	Planned Parenthood Surgical Instruments	Uterine curette, vas deferens separation forceps, fixation forceps for deferens, deferens extraction plate (hook)	2002
6815	Puncture injection equipment	Thyrocricocentesis needle, Skin prick box, Percutaneous puncture instrument, Glass syringes, amniocentesis needle	2002
6816	Burns (plastic) surgery instruments	Dermatome, Skin Graft Mesher, Electric / pneumatic dermatome,	2002
6820	General examination equipment	Fetal Stethoscope, Brain percussion hammer, ophthalmic examination lamp, Thermometer	2002
6821	Medical electronic equipment	Body composition analyzer, Hearing Aid Analyzers, Audiometer, Childbirth Monitor, Anesthetic index analyzer	2002
6822	Medical optical equipment, instruments and endoscopic equipment	Contrast sensitivity analyzer, Endoscopic camera system, Disposable stone extraction sacculus, Anesthesia video laryngoscope	Feb.2014
6823	Medical ultrasound equipment and related equipment	Doppler ultrasound system, Vascular flow meter system, Ultrasound Stethoscope, Diagnostic ultrasound images, Ultrasound bone densitometer	Aug. 2012
6824	Medical laser equipment	Helium-neon laser therapy machine, Laser knife, Assisted reproduction laser system, laser skin therapeutic apparatus, Laser melting fat analyzer	Feb.2014
6825	High-frequency medical equipment	Surgery electrode, electric coagulation tweezers, electric coagulation forceps, full - face photo rejuvenation apparatus, Endoscopic high-frequency surgical device, Microwave therapy unit	Feb.2014
6826	Physiotherapy and rehabilitation equipment	Sleep aid device, Joint orthosis, Automatic eye exercises meter, Effervescent mouthwash, Skin Needle, Anti-snoring device	Feb.2014
6827	Traditional Chinese medical equipment	Vacuum tank, Scrapping plate, three edged needle, Acupoint pressure stimulated stickers, traditional Chinese medical sweating detector	2002
6828	Magnetic resonance equipment for medical	MRI system, MRI breast coil piercing retainer	2002
6829	Ophthalmology instruments and appliances	Corneal topography, ophtalmometer / optometryuni, examination keratoscope used for corneal astigmatism, Dry eye detector	Feb.2014
6830	Medical X-ray equipment	Gastrointestinal X-ray equipment, X-ray machine, X-ray absorptiometry, X-ray photographic equipment, Extracorporeal shock wave lithotripsy machine	Aug. 2012
6831	Module and subsidiary equipment for medical X-ray	High-voltage generator, X ray contrast agent injection device, general X-ray tube, Electric Photography flat bed, CCD, CCD imaging system and other digital imaging system	Aug. 2012
6832	High-energy rays equipment for medical	Radiotherapy Simulator, multicavity balloon catheter device, Medical electron Linear Accelerator, X-ray stereotactic radiosurgery system	2002
6833	Medical radionuclide equipment	Gamma camera, Thyroid function analyzer, dermatology applicator, Image-guided monitoring and positioning system, Single photon emission computed tomography device (SPECT)	2002
6834	Protective equipment and fixtures for medical radiation	Microwave protection products, protection device like protective screen, Ray protective chair, Medical radiation guard supplies	Aug. 2012
6840	Clinical examination and analysis instrument	Sputum digestion, disinfection products, Staining sealant, Ovulation Tester, Biosensor chip analyzer, Blood gas analyzer electrode film	2002
6840	In vitro diagnostic reagents	Polyvalent diagnostic Sera for Shigella, Diagnose bacteria liquid of proteus OX2, Trisomy 21 and sex chromosome polyploid detection reagents, CD2 detection reagents	Nov.2013
6841	Medical assay device and basic equipment	Tissue processor, Slicer, Automatic chip pusher stainer system, CO2 incubator, Heatable forceps, Fecal analysis workstation	2002
6845	Extracorporeal circulation and blood processing equipment	Microthrombus filter, Peritoneal dialysis tube, The blood component separator, Plasma separator, Cell sorting beads	2002
6846	Implant materials and artificial organs	Human biological dressings, Absorbable nerve regeneration tube, Titanium mesh prosthesis, Stent, Silver clip	2002
6854	Equipment and appliance used in operating rooms, emergency rooms, clinics room utensils	slip-type skin expander, Smart infusion assistant, vacuum extractor, oxygen inhaler, Anesthesia machine evaporator	2002
6855	Equipment and appliance for department of stomatology	Teeth whitening pen, Dental implant surgery guide board, dental drill, bone powder stocker, Saliva suction head	2002
6856	Equipment and appliance for ward nursing	Ordinary sickbed, Electric anti-bedsore mattresses, suction nozzle for hepatic abscess, Manual operating table	2002
6857	Equipment and appliance for disinfection and sterilization	Medical glutaraldehyde disinfectant package, Microwave sterilizer, Blood thermostat light box, Cleaning and disinfection dryer	2002
6858	Medical cold therapy, low temperature, cold storage equipment and appliance	Cryosurgical System, Blood refrigerated container, Cold spray, Medical Physics cooling device, Liquid nitrogen storage system	2002
6863	dental material	Dental gold deposition solution, Polishing paste, Dental separating agent, Caries indicator	Mar.2014
6864	Medical hygienic materials and dressings	Alcohol pads, iodine swab, Elastic bandages, Plaster bandages, Carbon fiber dressing, Periodontal dressing	Mar.2014
6865	Medical suture materials and adhesives	Stainless steel sutures, Silk Line, Pure gold sutures, Catgut, Human albumin medical absorbable sutures	Mar.2014
6866	Medical polymer materials and products	Endoscopic irrigation tube, Electrode catheter, Suction bags, Anus canal.	2002
6870	Medical polymer materials and products	PACS, Vibrating sound bridge conditioners database, ECG Division Information Systems, Glucose data analysis software	Feb.2014
6877	Interventional appliances	PTA catheter, Balloon catheter, Balloon dilatation catheter, Balloon pressurizer, Intravascular angiography catheter	2002

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