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 | Legal Representative | 2,447 | ||
6 | Domestic medical device | Registration Certificates | 93,582 | ![]() |
7 | 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 |
| 105,032 | ![]() |
26 |
| 80,394 | |
27 |
| 48,254 | |
29 |
| 4,970 |
7. Top 10 list
No. | Number of registration certificate (by manufacturing area) | Number of registration certificate (by classified category) | ||
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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