Our Experience
Experience in NEW Medical Device Approval
| TFDA Category | Item |
| Cardiovascular Device |
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| Gastroenterology and urology devices |
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| General, plastic surgery and dermatology devices |
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| Neurological Devices |
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| Ophthalmic devices |
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| Physical medicine devices |
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Experience in General Medical Device Approval
| TFDA Category | Item |
| D Anesthesia devices | D.1400 Carbon dioxide gas analyzer D.5120 Anesthesia conduction catheter D.5130 Anesthesia conduction filter D.5140 Anesthesia conduction kit D.5150 Anesthesia conduction needle D.5895 Continuous ventilator |
| E Cardiovascular devices | E.0001 Cardiovascular stent E.0005 PTCA catheter E.0006 Endovascular graft system E.1130 Noninvasive blood pressure measurement system E.1200 Diagnostic intravascular catheter E.1210 Continuous flush catheter E.1220 Electrode recording catheter or electrode recording probe E.1240 Flow-directed catheter E.1250 Percutaneous catheter E.1255 Balloon aortic valvuloplasty catheter E.1280 Steerable catheter E.1300 Catheter cannula E.1330 Catheter guide wire E.1340 Catheter introducer E.1415 Coronary vascular physiologic simulation software device E.1425 Programmable diagnostic computer E.1650 Angiographic injector and syringe E.1750 External programmable pacemaker pulse generator E.2340 Electrocardiograph E.2700 Oximeter E.2800 Medical magnetic tape recorder E.2920 Telephone electrocardiograph transmitter and receiver E.3250 Vascular clip E.3545 Ventricular bypass (assist) device E.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting E.4450 Vascular clamp E.4875 Intraluminal artery stripper E.5150 Embolectomy catheter E.5175 Septostomy catheter |
| F Dental devices | F. 3640 Endosseous implant F.3645 Subperiosteal implant material F.3940 Total temporomandibular joint prosthesis F.4120 Bone cutting instrument and accessories F.4565 Dental hand instrument |
| G Ear, Nose, and Throat devices | G.4350 Ear, nose, and throat fiberoptic light source and carrier G.4420 Ear, nose, and throat manual surgical instrument |
| H Gastroenterology and Urology devices | H.1500 Endoscope and accessories H.4300 Endoscopic electrosurgical unit and accessories H.4890 Urological table and accessories H.5010 Biliary catheter and accessories H.5520 Urethral dilator H.5540 Blood access device and accessories H.5600 Sorbent regenerated dialysate delivery system for hemodialysis H.5630 Peritoneal dialysis system and accessories H.5820 Hemodialysis system and accessories H.5860 High permeability hemodialysis system H.5980 Extracorporeal shock wave lithotripter |
| I General, plastic surgery, and dermatology devices | I.0002 Collagen implant I.0007 Hyaluronic Acid implant I.3540 Silicone gel-filled breast prosthesis I.3550 Chin prosthesis I.3680 Nose prosthesis I.4025 Silicone scar management product I.4400 Electrosurgical cutting and coagulation device and accessories I.4493 Absorbable poly(glycolide/ L-lactide) surgical suture I.4750 Implantable staple I.4800 Manual surgical instrument for general use I.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology I.4840 Absorbable polydioxanone surgical suture I.5040 Suction lipoplasty system I.5010 Nonabsorbable polypropylene surgical suture I.5020 Nonabsorbable polyamide surgical suture |
| J General hospital and personal use devices | J.2910 Clinical electronic thermometer J.5200 Intravascular catheter J.5965 Subcutaneous, implanted, intravascular infusion port and catheter J.5970 Percutaneous, implanted, long-term intravascular catheter J.6880 Steam sterilizer J.6885 Liquid chemical sterilants/high level disinfectants |
| K Neurological devices | K.4370 Pneumatic cranial drill motor K.5550 Central nervous system fluid shunt and components K.5950 Artificial Embolization Device |
| L Obstetrics and Gynecology devices | L.1690 Hysteroscope and accessories L.6120 Assisted reproduction accessories |
| M Ophthalmic devices | M.0003 Lacrimal Punctum Plug M.1120 Ophthalmic camera M.1570 Ophthalmoscope M.1680 Ophthalmic projector M.1760 Ophthalmic refractometer M.1800 Schirmer strip M.1850 AC-powered slitlamp biomicroscope M.3600 Intraocular lens M.4100 Radiofrequency electrosurgical cautery apparatus M.4150 Vitreous aspiration and cutting instrument M.4270 Intraocular gas M.4275 Intraocular fluid M.4300 Intraocular lens guide M.4350 Manual ophthalmic surgical instrument M.4390 Ophthalmic laser M.4670 Phacofragmentation system M.4690 Ophthalmic photocoagulator M.5918 Rigid gas permeable contact lens care products M.5925 Soft (hydrophilic) contact lens M.5928 Soft (hydrophilic) contact lens care products |
| N Orthopedic devices | N.3040 Smooth or threaded metallic bone fixation fastener N.3060 Spinal intervertebral body fixation orthosis |
| O Physical medicine devices | O.1575 Force-measuring platform O.3490 Limb orthosis O.5500 Infrared lamp O.5650 Powered inflatable tube massager O.5700 Cold/Hot pack |
| P Radiology devices | P.1600 Angiographic x-ray system P.1650 Image-intensified fluoroscopic x-ray system P.1680 Stationary x-ray system P.1750 Computed tomography x-ray system |
| Others | In Vitro Diagnostic Medical Device (IVD) |