List of key products of medical devices, 4 categories of medical devices will meet major development
and cerebrovascular/ α- N-octyl cyanoacrylate liquid blood vessel / polyvinyl alcohol and other embolic agents, artificial blood such as recombinant hemoglobin oxygen carrying therapeutic agent / liposome encapsulated hemoglobin oxygen carrying therapeutic agent / polymerized hemoglobin oxygen carrying therapeutic agent, bovine Achilles tendon type I collagen membrane / porcine pericardium / bovine pericardium / expanded polytetrafluoroethylene and other dural repair materials, central nerve repair materials, hyaluronic acid and collagen and other soft tissue filling materials Cell tissue inducible biomaterials and bioactive dressings such as chitosan based / sodium alginate based dressings with hemostatic / anti-inflammatory / repair functions.
It is reported that this directory is the No. 1 announcement of 2017 issued by the national development and Reform Commission. It was announced in the beginning of the year, which was the No. 1 announcement. From this, we can see the importance attached by the state and relevant departments to the catalogue.
The catalogue covers 8 industries in 5 major fields. At the same time, it is subdivided into 174 sub directions under 40 key directions, with nearly 4000 subdivided products and services. Specifically, the medical and health industry includes the biomedical industry and the biomedical engineering industry, and the biomedical engineering industry is also the medical device industry.
Previously, in 2013, the national development and Reform Commission also published the 2013 edition of the guidance catalogue of key products and services of strategic emerging industries. However, the 2013 edition of the catalogue only covers 125 sub directions under 7 industries and 24 key development directions, with a total of more than 3100 subdivided products and services.
Compared with the 2013 version, the 2016 version of the catalogue adds one industry, namely, digital creative industry. It seems that the development momentum of digital creative industry in recent years is quite fierce. As for the subdivision direction, 16 key development directions and 49 sub directions were added, and nearly 900 subdivision products and services were added.
As for the medical device industry, in terms of the key directions, the 2016 edition basically follows the key directions of the 2013 edition, which are still four: medical imaging equipment and services, advanced treatment equipment and services, medical inspection and testing equipment and services, and implant biomedical materials and services, in addition to focusing on services and including the services matching the products for the first time. As for the list of key products in each key direction, there are many changes between 2016 and 2013.
Medical imaging equipment. Including multi-energy multi-slice spiral computed tomography (CT), permanent magnetic resonance or high field strength superconducting magnetic resonance imaging (MRI), magnetoencephalography (MEG) and functional near infrared spectroscopy (fNIRS), positron emission tomography (PET), high-performance ultrasound imaging (USI) and its integrated multimodal hybrid imaging equipment; High performance electronic endoscope / endoscope (ES) (such as gastroscope, laryngoscope, bronchoscope, laparoscope, arthroscopy, etc.) and its ultrasonic, optical coherence, fluorescence, confocal and other composite modality imaging systems; High performance digital radiography (DR), digital angiography (DSA), and digital radiography of gastrointestinal, breast, bladder, oral and other specialties; Portable, portable, mobile, vehicle mounted and other multi-functional medical imaging systems and their supporting equipment.
The core components include high-field superconducting magnet, Superconducting RF array surface coil, MRI cryogenic refrigerator, high heat capacity X-ray tube, fast multi row CT detector, amorphous silicon / oxide flat plate X-ray detector, magnetically compatible all digital solid PET detector, high-density array ultrasonic probe, low dose detector and other core components and key technologies.
Medical imaging services. Including supporting equipment and technology related to remote image diagnosis, mobile image diagnosis and treatment, third-party medical image center and other services.
2. Advanced treatment equipment and services
Tumor treatment equipment. Including the radiotherapy system of electron linear accelerator, proton / heavy ion cyclotron and its high-precision treatment planning system with advanced functions such as real-time motion tracking, image guidance, conformal and intensity modulation; Magnetic induction, high-intensity focused ultrasound (HIFU), radio frequency, microwave, argon helium knife and other tumor hyperthermia, ablation, cryotherapy equipment and treatment monitoring system; Boron neutron capture therapy system and its targeted drugs.
Surgical treatment equipment. Including intraoperative positioning, intraoperative imaging, intraoperative monitoring, image navigation and other equipment and information systems; Digital and integrated mixed operating room equipment and information system for surgery, interventional treatment, intraoperative treatment, minimally invasive treatment, etc; Abdominal cavity, thoracic cavity, Urology, orthopaedics, interventional surgery and other auxiliary robots and their supporting minimally invasive surgical instruments; High performance laser, ultrasound, plasma, high frequency and other new hand tools, digital anesthesia machine workstation with anesthesia depth monitoring and control functions.
Rehabilitation treatment equipment. Including implantable nerve stimulator, multi chamber cardiac pacemaker, implantable defibrillator and cochlear implant; Acoustic and photodynamic therapy and their sensitizers; Ultra fast electromagnetic pulse, ultra-high static electric field, high-power laser, electromagnetic field, electromagnetic wave, ultrasound, optics, mechanics and other rehabilitation physiotherapy equipment; Rehabilitation training and treatment robot with real-time three-dimensional muscle strength evaluation, gait analysis, balance evaluation control, limb linkage, functional electrical stimulation (FES), biofeedback, motion monitoring, sensory testing and other functions; Rehabilitation training and evaluation system for body function training, behavior, psychology and cognitive intervention.
Specialized treatment equipment. Including ophthalmic excimer laser therapeutic instrument, urinary laser therapeutic instrument, endoscopic laser therapeutic instrument and oral treatment equipment; Three dimensional mapping of cardiac conduction and radiofrequency ablation treatment system based on image fusion; TCM treatment equipment based on traditional medical principles.
Life support equipment. Including a high-performance ventilator with a new ventilation mode, an artificial cardiopulmonary machine, an extracorporeal membrane oxygenation system, and a cardiac function assist device; Continuous blood purification system, hemodialysis machine, peritoneal dialysis machine, artificial liver therapeutic instrument, blood perfusion, plasma adsorption and plasma exchange equipment and consumables; Intensive care system, automatic defibrillator, cardiopulmonary resuscitation device.
Rehabilitation services. Including the supporting equipment and technology related to the third-party tumor radiotherapy center, community blood purification center, community chronic disease treatment center, community rehabilitation physiotherapy center, community rehabilitation training center and other services.
3. Medical inspection instruments and services
Medical inspection and testing instruments. Including ECG, EEG, EMG, evoked potential, eye myoelectric and other electrophysiological signal detection analyzers, new blood vessel function, cardiac function, pulmonary function and cardiopulmonary function test analyzers, continuous ambulatory ECG, EEG, blood pressure, blood sugar, hemoglobin and other detection analyzers, low physiological and low psychological load respiratory and sleep monitoring analyzers, and multi-functional and multi parameter physiological parameter monitors; Doppler blood flow imager, ultrasonic bone density detection analyzer, ophthalmic optical coherence tomography (OCT) and other specialized diagnostic equipment; Noninvasive / minimally invasive intracranial pressure monitor, noninvasive / minimally invasive blood glucose tester, noninvasive living biochemical analysis device; Health information terminals, general examination devices, life information monitoring devices and related information systems and cloud platforms based on Internet of things, wearable, sensor networks, mobile communications, global positioning and other technologies; Screening and diagnosis equipment for major chronic diseases such as lung cancer, gastric cancer, liver cancer, intestinal cancer, breast cancer and cervical cancer.
In vitro diagnostic testing instrument. Including high-precision, high-throughput (fast) and automatic biochemical, electrolyte, blood gas, urine, body fluid, feces, vaginal secretion, hemoglobin, glycosylated hemoglobin, specific protein, blood cell, microorganism, metabolism, nutrition, hemagglutination and other detection and analysis instruments (including dry type) and disease diagnosis and screening information system; Automatic, high-throughput and high-sensitivity immunoassay system with enzyme-linked photometry, electrochemistry, chemiluminescence, electrochemiluminescence, fluorescence, time-resolved fluorescence, homogeneous time-resolved fluorescence and other methods, instruments related to tissue / cell detection and analysis, automatic immunohistochemical staining instrument and its supporting reagents; Medical mass spectrometry analyzer, medical chromatography analyzer, micro spectrophotometer, automatic blood type analyzer, flow cytometry analyzer, confocal scanner, on-site rapid multi parameter biochemical detector (POCT), microbial culture instrument; Mercury free thermometer, various in vitro diagnostic reagents, test paper and its supporting equipment and consumables.
Molecular diagnostic testing instrument. Including real-time fluorescence quantitative PCR instrument, fluorescence in situ hybridization instrument, high-throughput gene sequencer, constant temperature chip nucleic acid real-time detection system, biochip reader, biochip hybridization instrument, biochip drying instrument, super-resolution molecular microscopy imaging system, and fast and automatic nucleic acid extractor; Molecular biological information analysis and processing system.
Medical examination and testing services. Including the supporting equipment and technology related to the third-party in vitro diagnosis center, health examination center, health archives and information collection center, molecular diagnosis information center, health hut and other services.
4. Biomedical materials and services for implant intervention
Biomedical implant. Including medical catheters and guidewires such as angiography / central vein / balloon dilation, drug-eluting and degradable cardiovascular stents, cerebrovascular stents and large artery stents; Congenital heart disease occluder, mechanical / biological artificial heart valve, polyester / expanded polytetrafluoroethylene / biological / bioceramic artificial blood vessel, hip / knee / shoulder artificial joint prosthesis, bone induced artificial bone, soft / hard artificial lens, artificial cornea / amnion and other Ophthalmic implants, polyester / carbon fiber / biological artificial ligament; New biomedical implant based on tissue engineering, bioprinting and 3D printing.
Biomedical materials. Including bioceramic bone repair materials such as collagen based / polylactate based / tantalum based with drug slow-release function, active calcium silicate / calcium phosphate composite bone cement, artificial bone / metal bone fixation materials, artificial intervertebral disc and other bone implant materials, dental implants such as implant / periodontal tissue guided collagen membrane / dental special collagen hemostatic sponge, biocompatible skin repair and beauty control slow-release medicinal biofilm materials of insect animal origin, and cerebrovascular/ α- N-octyl cyanoacrylate liquid blood vessel / polyvinyl alcohol and other embolic agents, artificial blood such as recombinant hemoglobin oxygen carrying therapeutic agent / liposome encapsulated hemoglobin oxygen carrying therapeutic agent / polymerized hemoglobin oxygen carrying therapeutic agent, bovine Achilles tendon type I collagen membrane / porcine pericardium / bovine pericardium / expanded polytetrafluoroethylene and other dural repair materials, central nerve repair materials, hyaluronic acid and collagen and other soft tissue filling materials Cell tissue inducible biomaterials and bioactive dressings such as chitosan based / sodium alginate based dressings with hemostatic / anti-inflammatory / repair functions.
Biomedical materials services. Including personalized medical implant intervention manufacturing service center and its related supporting equipment and technology.