Changing the "Medical Device Business License" licensing matters, the medical device business enterprise should fill out the "Medical Device Business License" application for change, and submit the "business license" and "Medical Device Business License" copy of the enterprise seal, and then apply for a change in the scope of business, should be submitted at the same time to ensure that the increased range of products and then the following storage conditions. Should be submitted at the same time to operate a copy of the certificate of registration of the product and the corresponding storage conditions, to ensure that the increase in the scope of products and then the following range:
Currently, the State Administration of Medicine classified three types of medical devices are as follows: Classification directory Name Name Examples 6804 ophthalmic surgical instruments ophthalmic surgical instruments vitrectomy vitreous cutters 6815 injectable puncture instruments injectable puncture instruments single-use Sterile syringes and their plugs, single-use sterile injection needles, disposable intravenous infusion needles, single-use fiberoptic needles, intravenous indwelling needles, disposable injection needles for dispensing medications, puncture needles6821 Medical electronic instruments and equipment Implantable cardiac pacemakers for heart treatment, first aid devices, external cardiac pacemakers, cardiac defibrillators, cardiac pacemakers, aortic endobaginal counterpulsation devices, cardiac defibrillator pacemakersInvasive Invasive electrophysiological devices and innovative electrophysiological devicesExtracorporeal shockwave lithotripter, invasive patient monitoring system, intracranial pressure monitor, invasive cardiac output meter, invasive multicontact physiological recorder, intracardiac Hirschsprung's Bundle electrography, intra- and extracardiac endocardiac membrane specimen mapping device, invasive electronic sphygmomanometerInvasive medical sensors Various kinds of implanted medical sensorsNon-invasive monitoring devicesHeart rate dysrhythmia analyzers and alarms, monitors with S-T segmentMedical StimulatorsCardiac workstationsElectrical stimulatorsExtracorporeal counterpulsation and its auxiliary circulatory devicesBalloon type extracorporeal counterpulsation devices6822 Medical optical appliances, instruments and endoscopic equipmentImplanted in the body or in long-term contact with the bodyOphthalmic optical appliancesOcular IOLs, corneal contact lenses (soft, hard, plastic corneal contact lenses) and nursing fluids, intraocular fillers (vitreous etc.), viscoelastic substances, instillation fluids (heavy water, silicone oil) Endoscopes for cardiac and vascular, invasive, and endoluminal surgery Invasive endoscopes (laparoscopes, arthroscopes, nephroscopes, pancreatoscopes, discectoscopes, cerebral sinusoscopes, and choledochoscopes), cardiac and vascular endoscopes (cardiac endoscopes, vascular endoscopes), and endoscopes for endoluminal surgery (transurethral electrodescopes, fiber-optic endoscopes for high-frequency electrodescopes, and rigid duct endoscopes) Electronic endoscopes for the upper gastrointestinal tract, bronchial tubes, colon, and colorectum, Pancreas and other electronic endoscopes 6823 medical ultrasound instruments and related equipment ultrasound surgery and focused therapy equipment ultrasound tumor focused knife, ultrasound high-intensity focused tumor therapy system, ultrasound fat emulsifier, ultrasound ophthalmic emulsification therapy, ultrasound scalpel, ultrasound intravascular interventional therapy, ultrasound breast thermotherapy therapy device color ultrasound imaging equipment and ultrasound interventional/intravitreal diagnostic equipment ultrasound 3-D (stereo) Diagnostic instrument, fully digital color ultrasound instrument, ultrasound color Doppler, intravascular ultrasound diagnostic instrument, ultrasound colonoscopy (diagnostic instrument), ultrasound endoscopy Doppler, ultrasound intracardiac imaging instrument, transcranial ultrasound Doppler, ultrasound ophthalmic special diagnostic instrument, composite scanning ultrasound diagnostic instrument 6824 Medical Laser Instruments and Equipment Laser Surgical and Therapeutic Devices Solid-state Laser Surgical Devices (Nd:YAG, Ho:YAG, Er:YAG, ruby, sapphire, emerald green), gas laser surgery equipment (CO2, gold vapor, excimer, argon ion), Class 3B and Class 4 semiconductor laser therapy, nitrogen molecule laser therapy, ophthalmic laser photocoagulation machine, ophthalmic crystal laser emulsification equipment, laser vascular welding machine laser diagnostic instruments laser ophthalmic diagnostic apparatus, ophthalmic laser scanner, interventional laser diagnostic and treatment equipment He- Ne laser intravascular irradiation therapy instrument, other laser sources of intravascular irradiation therapy instrument laser surgical instruments laser microsurgical instruments, corneal laminator for LASIK 6825 medical high-frequency instruments and equipment high-frequency surgical and electrocoagulation equipment high-frequency electrocautery, high-frequency tonsil surgery, endoscopic high-frequency surgical instruments, posterior urethral electrocutaneous cutter, high-frequency ophthalmic coagulation, high-frequency polyp surgical instruments, high-frequency turbinate coagulation instrument, radio frequency temperature-controlled thermal Microwave therapy equipment microwave scalpel, microwave tumor thermotherapy instrument, microwave prostate therapy instrument, microwave therapy machine radiofrequency therapy equipment radiofrequency prostate therapy instrument, radiofrequency ablation cardiac therapeutic instrument, radiofrequency ablation prostate therapeutic instrument, endobiological tumor thermotherapy system, tumor radiofrequency thermotherapy machine 6826 Physical Therapy and Rehabilitation Equipment Hyperbaric Oxygen Therapy Equipment Air-pressurized Oxygen Chamber, Oxygen-pressurized Oxygen Chamber Electrotherapeutic Instruments In vivo Low Frequency Pulse therapy instrument, electrochemical cancer therapy machine spectral radiation therapy instrument photo-quantum blood therapy machine (oxygenated magnetized light) hyperbaric potential therapy equipment hyperbaric potential therapeutic instrument 6828 medical magnetic **** vibration equipment medical magnetic **** vibration imaging equipment (MRI) permanent magnet-type magnetic **** vibration imaging system, normal conduction magnetic **** vibration imaging system, superconducting magnetic **** vibration imaging system 6830 medical X-ray Equipment X-ray therapy equipment X-ray deep therapy machines, X-ray superficial therapy machines, X-ray contact therapy machines X-ray diagnostic equipment X-ray diagnostic equipment above 200mA X-ray surgical imaging equipment X-ray interventional X-ray machines X-ray computed tomography equipment (CT) X-ray head CT machines, whole-body CT machines, helical CT machines, helical fan-scanning CT machines 6832 Medical high-energy radiation equipment Medical high-energy ray therapy equipment X-ray stereotactic radiosurgery treatment system, medical electronic linear gas pedal, medical cyclotron, medical neutron therapy machine, medical proton therapy machine high-energy ray therapy localization equipment radiation therapy simulator, conformal therapy multi-page light bar 6833 Medical nuclide equipment radionuclide therapy equipment cobalt 60 therapy machine, other tele-radionuclide therapy device, nuclide Post-loading brachytherapy machine, implanted radioactive sources radionuclide diagnostic equipment ECT, positron emission tomography device (PECT), single photon emission tomography device (SPECT), radionuclide scanner 6840 Clinical laboratory and analytical instruments blood analysis system blood analyzer, blood type card immunoanalysis system fully automated immunoanalyzers bacteriological analysis system Mycobacterium tuberculosis analyzers, drug sensitivity Analyzers Genetic and Life Science Instruments Automatic Medical PCR Analysis Systems 6845 Extracorporeal Circulation and Blood Processing Equipment Artificial Heart and Lung Equipment Artificial Heart and Lung Machines Oxygenators Bubble Oxygenators, Membrane Oxygenators Artificial Heart and Lung Equipment Auxiliary Devices Blood Pumps, Blood Storage Filters Blood Filters, Microplug Filters, Blood Filters, Water Filters (Ultrafiltration), Bubble Removers, Pumping Tubes, Blood Circuits Blood Purification Devices and Blood Cleansing Apparatus Hemodialysis Hemodialysis device, hemodialysis filtration device, blood filtration device, blood purification pipeline, dialysis blood line, blood line plastic pumping tube, arterial and venous puncture device, multi-layer plate type dialyzer, hollow fiber dialyzer, hollow fiber filtration, adsorbent, plasma separator, blood detoxification (perfusion perfusion) device, blood purification extracorporeal circulation blood line (pipeline), intra-operative autologous blood re-infusion machine blood purification equipment auxiliary equipment roller column Centrifugal Blood Transfusion Pumps, Micro-Infusion Pumps Body Fluid Processing Devices Mono-collecting Plasma Machines, Human Blood Processing Machines, Ascites Concentration Machines, Blood Component Transfusion Devices, Blood Component Separation Machines Dialysis Powder, Dialysis Solution 6846 Implantable Materials and Artificial Organs Implantable Devices Bone Plates, Bone Nails, Bone Pins, Bone Bars, Spinal Internal Fixation Devices, Ligature Wires, Gathering Patellar Devices, Bone Waxes, Bone Repairing Materials, Cerebral Aneurysm Clips, Silver Clips, Vascular Anastomosis Clips ( device), orthopedic materials, cardiac or tissue repair materials, intraocular filling materials, birth control rings, nerve patches implantable artificial organs artificial esophagus, artificial blood vessels, artificial vertebrae, artificial joints, artificial urethra, artificial valves, artificial kidneys, prosthetic breasts, artificial cranium, artificial jawbone, artificial heart, artificial tendons, cochlear implants, artificial anus closure contact artificial organs artificial laryngeal, artificial skin, artificial corneal Stents vascular stents, prostate stents, biliary stents, esophageal stents organ-assisting devices implantable hearing aids, artificial liver support devices 6854 Operating room, emergency room, diagnostic and treatment room equipment and apparatus Surgical and emergency devices Surgical robots, surgical navigation systems, brain stereotactic apparatus Respiratory equipment Various types of electric and pneumatic ventilators, synchronized ventilators, high-frequency jet ventilators Respiratory anesthesia equipment and accessories Various types of vertical Anesthesia machine, comprehensive anesthesia machine, pediatric anesthesia machine infant care equipment various premature baby incubator, radiation neonatal resuscitation table, neonatal transport incubator infusion aids insulin pumps, disposable infusion analgesic pumps, chemotherapy pumps 6858 Medical Cold Therapy, Cryogenic, Refrigeration Equipment and Apparatus Cryogenic Therapy Instruments in vivo tumor cryotherapy instrument, liver cryotherapy instrument, rectal cancer cryotherapy instrument 6863 Stomatology Materials polymer denture materials synthetic resin teeth, denture base resin, denture soft lining materials, tooth-making powder and tooth-making water dental implant materials dental metal and alloy implant materials, dental ceramic implant materials, dental polymer implant materials, dental carbon implant materials, dental composite implant materials root canal filling materials solid root filling materials, root filling paste, liquid root filling materials periodontal plugging agent maxillofacial restorative materials Permanent Filling materials and related materialsSilver alloy powder, composite resin filling materials, cementoids, dentin adhesives, cavity lining agents, cushioning materials, pulp-covering materials, whitening gels6864Medical hygiene materials and dressingsAbsorbable haemostatic and anti-adhesion materialsGelatin sponges, collagen sponges, bio-protein gels, sodium hyaluronate gels, polylactic acid anti-adhesion membranes6865Medical suture materials and adhesivesAbsorbable sutures for medical use (with needle / without needle) a variety of polyethylene glycol suture, polylactic acid suture, collagen suture, sheep intestines medical adhesives such as bone cement and other cohesive adhesive materials, medical α-cyanoacrylate lipids, tubal plugging agent, vascular anastomosis adhesive, epidermal adhesive, adhesive tape, bio-adhesive, medical chitinose 6866 Medical Polymer Materials and Products Transfusion, transfusion appliances and tubing disposable infusion set, blood transfusion Transfusion, blood transfusion apparatus, intravenous infusion (blood) needles, blood bags, blood collection devices, blood component separation equipment, connecting pipelines, switches in contact with the blood path, blood filters, drug filtration filters, air filtration filters, anesthesia catheters, disposable blood filters catheters, drainage tubes thoracic drainage tubes, abdominal drainage tubes, cerebral fluid shunts 6870 Software Functions Programmed software X-ray stereotactic radiosurgical treatment system localized Network radiation therapy systems, radiation therapy planning systems, diagnostic image processing software digital image receiving systems, X-ray image processing systems, software for imaging with X-ray computed tomography equipment, intravascular ultrasound imaging systems (IVUS), nuclear medicine imaging medical magnetic **** vibration imaging systems 6877 Interventional devices intravascular catheters endovascular catheters endovascular angiographic catheters, balloon dilatation catheters, central venous catheters, Sleeve peripheral catheters, microfloating catheters, arterial and venous manometry catheters. Contrast catheters, balloon catheters, PTCA catheters, PTA catheters, microcatheters, thrombolytic catheters, guideline catheters, ablation catheters, tracing balloon guidewires and sheaths hard guidewires, soft-tipped guidewires, renal artery guidewires, microcatheters, push guidewires, ultra-smooth guidewires, arterial sheaths, venous vascular sheaths, micropuncture vascular sheaths embolization devices filters, spring embolus, embolization microspheres, platinum microprojectiles, blocking devices.