When a medical device business enterprise changes the licensed items of the Medical Device Business License, it shall fill in the Application for Change of the Medical Device Business License, submit the business license stamped with the enterprise seal and a copy of the Medical Device Business License, and then apply for changing the business scope. It shall also submit a copy of the registration certificate of the products to be operated and a description of the corresponding storage conditions to ensure that the products to be added are within the following scope:
At present, the three types of medical devices classified by the State Administration of Medicine are as follows: Category Name Product Name Example 6804 Ophthalmic Surgical Instruments Other Instruments Vitreous Cutter 68 15 Injection Puncture Instruments Disposable Sterile Syringe and Its Rubber Plug, Disposable Sterile Needle, Disposable Intravenous Infusion Needle, Disposable Optical Fiber Needle, Venous Indwelling Needle, Disposable Dispensing Needle and Puncture Needle 682 1 Medical electronic equipment is used in cardiac therapy, first-aid instruments, implantable pacemakers, external pacemakers, cardiac defibrillators, cardiac pacemakers, intra-aortic balloon counterpulsors, cardiac defibrillation pacemakers, invasive electrophysiological instruments and innovative electrophysiological instruments, extracorporeal shock wave lithotripsy, invasive patient monitoring system, intracranial pressure monitor, invasive cardiac output meter, invasive multi-channel physiological recorder and intracardiac His bundle electrogram machine. Epicardial mapping instrument, invasive electronic sphygmomanometer, invasive medical sensor, various medical sensors implanted in the body, non-invasive monitoring instrument, arrhythmia analyzer and alarm, monitor with S-T segment, medical stimulator, cardiac workstation, electric stimulator, external counterpulsation and its auxiliary circulation device, balloon external counterpulsation device 6822, medical optical instruments, instruments and endoscopic equipment, ophthalmic optical instruments implanted in the body or in long-term contact with the body, intraocular lens, etc. ), viscoelastic substances, perfusate (heavy water and silicone oil), heart and blood vessels, invasive endoscopes for intracavitary surgery (laparoscopy, arthroscopy, nephroscope, pancreatic endoscope, intervertebral disc endoscope, cerebral sinus endoscope, choledochoscope), heart and blood vessels (choledochoscope) fiberoptic endoscope and hard tube endoscope for high-frequency electrotomy) on the digestive tract, bronchus, large intestine, colon and endoscope. 6823 medical ultrasonic instruments and related equipment ultrasonic surgery and focused treatment equipment ultrasonic tumor focusing knife, ultrasonic high-intensity focused tumor treatment system, ultrasonic fat emulsifier, ultrasonic ophthalmic emulsification therapeutic instrument, ultrasonic scalpel, ultrasonic intravascular interventional therapeutic instrument, color ultrasonic imaging equipment and ultrasonic interventional/intracavitary diagnostic equipment ultrasonic breast hyperthermia therapeutic instrument, ultrasonic three-dimensional (three-dimensional) diagnostic instrument, full-digital color Doppler ultrasonic instrument, ultrasonic color Doppler, Intravascular ultrasonic diagnostic instrument, ultrasonic colonoscopy (diagnostic instrument), ultrasonic endoscopic Doppler, ultrasonic intracardiac imager, transcranial ultrasonic Doppler, ultrasonic ophthalmology special diagnostic instrument, compound scanning ultrasonic diagnostic instrument 6824 medical laser equipment laser surgery and treatment equipment solid laser surgery equipment (Nd:YAG, Ho:YAG, Er:YAG, ruby, sapphire, emerald), gas laser surgery equipment (CO2, gold vapor, emerald). Laser vascular welding machine laser diagnostic instrument laser ophthalmic diagnostic instrument, ophthalmic laser scanner, interventional laser diagnostic instrument He-Ne laser intravascular irradiation therapeutic instrument, other laser internal irradiation therapeutic instrument laser surgical instrument laser microsurgery, corneal lamellar knife 6825 medical high-frequency instrument and equipment LASIK high-frequency surgery and electrocoagulation equipment high-frequency electrotome, high-frequency tonsil surgical instrument, endoscopic high-frequency surgical instrument, posterior urethral electrotome, high-frequency ophthalmic electrocoagulation device, High-frequency polyp surgical instruments, high-frequency turbinate electrocoagulator, radio-frequency temperature-controlled microwave scalpel, microwave tumor hyperthermia instrument, microwave prostate therapeutic instrument, radio-frequency prostate therapeutic instrument, radio-frequency ablation heart therapeutic instrument, radio-frequency prostate therapeutic instrument, tumor hyperthermia system in vivo, tumor radio-frequency hyperthermia machine 6826 physiotherapy rehabilitation equipment, hyperbaric oxygen therapeutic instrument, air pressurized oxygen chamber, low-frequency pulse therapeutic instrument in oxygen pressurized oxygen chamber electrotherapy instrument, Electrochemical cancer therapeutic instrument Spectral radiation therapeutic instrument Optical quantum blood therapeutic instrument (oxygenated magnetized lighting) High voltage potential therapeutic instrument 6828 Medical magnetic vibration equipment Medical magnetic vibration imaging equipment (MRI) Permanent magnetic vibration imaging system, normally magnetic vibration imaging system, superconducting magnetic vibration imaging system 6830 Medical X-ray equipment X-ray deep treatment machine, X-ray superficial therapy machine, X-ray contact therapy machine, X-ray diagnostic equipment, X-ray surgical imaging equipment, interventional therapy X-ray machine, X-ray computed tomography equipment (ct) X-ray head CT machine whole body CT machine spiral CT machine spiral fan CT machine 6832 medical high-energy ray equipment medical high-energy ray therapy equipment medical high-energy ray stereotactic radiosurgery treatment system medical electronic linear accelerator medical cyclotron medical neutron therapy machine medical proton therapy machine high-energy ray therapy positioning equipment radiotherapy simulator, conformal therapy multi-page light bar 6833 medical radionuclide therapy equipment cobalt 60 therapy machine, Other long-distance radionuclide therapy equipment, radionuclide afterloading brachytherapy machine, radionuclide diagnostic equipment ECT implanted with radioactive source, positron emission tomography (SPECT), single photon emission tomography (SPECT), radionuclide scanner 6840 clinical laboratory analytical instrument blood group analyzer, blood group card immunoassay system full-automatic immune analyzer, bacterial analysis system, mycobacterium tuberculosis analyzer, drug sensitivity analyzer, Gene and life science instruments, automatic medical PCR analysis system 6845 extracorporeal circulation and blood processing equipment, artificial heart and lung equipment, artificial heart and lung machine oxygenator, bubble oxygenator, membrane oxygenator, artificial heart and lung equipment, auxiliary device, blood pump, blood storage filter, micro-plug filter, blood filter, water filter (ultrafiltration), defoamer, pump pipe, blood purification equipment and blood purification equipment, hemodialysis device, hemodialysis. Blood filtration device, blood purification pipeline, dialysis blood circuit, blood circuit plastic pump tube, arteriovenous puncture device, multilayer flat dialyzer, hollow fiber dialyzer, hollow fiber filter, adsorber, plasma separator, blood detoxification (perfusion) device, blood purification extracorporeal circulation blood circuit (pipeline), intraoperative autologous blood transfusion machine, blood purification equipment auxiliary device, roller centrifugal blood transfusion pump, micro perfusion pump, body fluid treatment equipment, plasma. Ascites concentrator, blood component infusion set, dialysis powder for blood component separator, dialysate 6846 implant materials and artificial organ implantation equipment, bone plates, bone nails, bone needles, bone rods, spinal internal fixation equipment, ligating wires, patellar concentrator, bone wax, bone repair materials, aneurysm clips, silver clips, vascular anastomosis clips (devices), plastic materials, heart or tissue repair materials, and intraocular filling materials. Artificial vertebral body, artificial joint, artificial urethra, artificial valve, artificial kidney, artificial breast, artificial skull, artificial jaw, artificial heart, artificial tendon, artificial cochlea, artificial anal obturator contact artificial organ artificial larynx, artificial skin, artificial corneal stent, prostate stent, biliary tract stent, esophageal stent, organ auxiliary device, implantable hearing aid, artificial liver support device 6854 operating room, emergency room, clinical equipment and appliances. Surgical robots, surgical navigation systems, brain stereotactic breathing equipment, various electric and pneumatic ventilators, synchronous ventilators, high-frequency jet ventilators, respiratory anesthesia equipment and accessories, various vertical anesthesia machines, comprehensive anesthesia machines, pediatric anesthesia machines, infant care equipment, various incubators for premature infants, radiation neonatal rescue tables, neonatal transfer incubators, infusion sets, insulin pumps, disposable infusion analgesia pumps, chemotherapy pumps 6858 medical cold therapy, Cryogenic refrigeration equipment and instruments Tumor cryotherapy instrument, Liver cryotherapy instrument, Rectal cancer cryotherapy instrument 6863 Dental materials Polymer denture materials Synthetic resin teeth, denture base resin, denture soft lining materials, Tooth powder and 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 canal filling materials root canal filling paste liquid root canal filling materials periodontal plug maxillary surface repair materials and related materials silver alloy powder, composite resin filling materials, cements, dentin adhesives, cavity linings, padding materials, pulp capping materials, whitening glue 6864 medical sanitary materials and dressings, absorbable hemostatic and anti-adhesion materials, and so on. Polylactic acid anti-adhesion membrane 6865 medical suture material and adhesive medical absorbable suture (with or without needle) polyethylene glycol suture, polylactic acid suture, collagen suture, catgut medical adhesive bone cement, medical α-cyanoacrylate, oviduct sealant, vascular anastomosis adhesive, epidermal adhesive, adhesive tape, biological adhesive, medical chitosan 6866 medical polymer materials and products infusion, blood transfusion device and pipeline disposable infusion device, blood transfusion device, Intravenous infusion (blood) needle, blood bag, blood collector, blood component separation equipment, connecting pipeline, switch contacting with blood loop, blood filter screen, liquid medicine filter membrane, air filter membrane, anesthesia catheter, disposable blood filter catheter, drainage tube, thoracic drainage tube, abdominal drainage tube, cerebral effusion shunt tube 6870 software function programming software X-ray stereotactic radiosurgery treatment system local network radiotherapy system, radiotherapy planning system, Diagnostic image processing software Digital image receiving system, X-ray image processing system, imaging software of X-ray computed tomography equipment, intravascular ultrasound imaging system (IVUS), nuclear medical imaging medical magnetic resonance imaging system 6877 interventional equipment intravascular catheter imaging catheter, balloon catheter, PTCA catheter, PTA catheter, microcatheter, thrombolytic catheter, guiding catheter, ablation catheter, tracking balloon guide wire and sheath hard guide wire, soft-headed guide wire, Renal artery guide wire, micro-guide wire, push guide wire, ultra-smooth guide wire, arterial sheath, venous vascular sheath, micro-puncture vascular sheath embolization device filter, spring embolus, embolization microspheres, platinum micro-embolus and occluder.