衛生福利部公告
中華民國110 年 4 月 28 日 衛授食字第1101603553 號
主 旨：訂定「應建立與保存來源及流向資料之醫療器材」及「應申報來源及流向資料之醫療 器材品項」，並自中華民國一百十年五月一日生效。
依 據：醫療器材管理法第十九條第一項及第二項。
公告事項：
一、 「應建立與保存來源及流向資料之醫療器材」為醫療器材分類分級管理辦法所定第二 等級及第三等級植入式醫療器材如附件。
二、「應申報來源及流向資料之醫療器材品項」依醫療器材分類分級管理辦法所定如下：
(一) E.3610 植入式心律器之脈搏產生器。
(二) I.3540 矽膠充填之乳房彌補物。
(三) L.5980 經陰道骨盆腔器官脫垂治療用手術網片。
部 長 陳時中
「應建立與保存來源及流向資料之醫療器材」附件
項 品項代碼 中文名稱 英文名稱 等級
1 E.0001 心血管支架 Cardiovascular stent 2,3 2 E.0006 血管內移植系統 Endovascular graft system 3
3 E.3250 血管夾 Vascular clip 2
4 E.3260 靜脈腔室夾 Vena cava clip 2 5 E.3300 動脈栓塞裝置 Arterial embolization device 3 6 E.3375 心血管之血管內過濾器 Cardiovascular intravascular filter 2 7 E.3450 血管移植彌補物 Vascular graft prosthesis 2 8 E.3460 血管內縫線系統 Endovascular Suturing System 2 9 E.3470 聚丙烯、聚乙烯、對苯二甲
酸等材質製成之心內補片或 小拭子
Intracardiac patch or pledget made of polypropylene,polyethylene terephthalate, or
polytetrafluoroethylene
2
10 E.3545 心室血管繞道術(輔助)裝置 Ventricular bypass (assist) device 3 11 E.3610 植入式心律器之脈搏產生器 Implantable pacemaker pulse
generator
3
12 E.3620 心律器導線接頭 Pacemaker lead adaptor 2 13 E.3680 心血管用永久或暫時性之心
律調節器電極
Cardiovascular permanent or temporary pacemaker electrode
2,3
14 E.3710 心律調節器修復或置換之材 料
Pacemaker repair or replacement material
3
15 E.3800 環狀成形術環 Annuloplasty ring 2 16 E.3850 頸動脈竇神經刺激器 Carotid sinus nerve stimulator 3 17 E.3925 心臟瓣膜置換物 Replacement heart valve 3 18 E.4450 血管夾 Vascular clamp 2 19 E.4510 心尖閉合器 Apical closure device 2 20 F.3060 牙科使用金基合金和貴重金
屬合金
Gold based alloys and precious metal alloys for clinical use
2
21 F.3070 牙科用汞齊、水銀、汞齊合 金
Dental amalgam, mercury, and amalgam alloy
2
22 F.3250 氫氧化鈣窩洞襯底 Calcium hydroxide cavity liner 2 23 F.3260 窩洞塗料 Cavity varnish 2 24 F.3310 樹脂充填用塗覆材料 Coating material for resin fillings 2 25 F.3640 骨內植體 Endosseous implant 3 26 F.3645 骨膜下植體材 Subperiosteal implant material 2
27 F.3680 聚四氟乙烯玻璃狀碳材料 (聚化玻璃黏著劑)
Polytetrafluoroethylene (PTFE) vitreous carbon material
2
28 F.3690 樹脂牙材 Tooth shade resin material 2 29 F.3710 卑金屬合金 Base metal alloy 2 30 F.3765 凹窩封閉劑及調節劑 Pit and fissure sealant and
conditioner
2
31 F.3820 根管充填樹脂 Root canal filling resin 2,3 32 F.3890 根管固定夾板 Endodontic stabilizing splint 2 33 F.3930 牙槽修復材料 Bone grafting material 2,3 34 F.3940 全顳顎關節彌補物 Total temporomandibular joint
prosthesis
3
35 F.3950 顳骨關節盂彌補物 Glenoid fossa prosthesis 3 36 F.3960 下頜髁彌補物 Mandibular condyle prosthesis 3 37 F.3970 關節間盤彌補物(內置式植
入物)
Interarticular disc prosthesis (interpositional implant)
3
38 F.4760 骨板 Bone plate 2
39 F.4880 骨內固定螺釘或金屬線 Intraosseous fixation screw or wire 2 40 F.5560 電子式唾液刺激系統 Electrical salivary stimulatory
system
2
41 F.6660 牙科用瓷粉 Porcelain powder for clinical use 2 42 G.0001 人工耳蝸植入器 Cochlear implant 3 43 G.3315 鼓膜接觸式助聽器 Tympanic membrane contact hearing
aid
2
44 G.3430 中耳模 Middle ear mold 2 45 G.3450 部分聽小骨置換物 Partial ossicular replacement
prosthesis
2
46 G.3495 全聽小骨置換物 Total ossicular replacement prosthesis
2
47 G.3620 耳鼻喉科用合成聚合物材料 Ear, nose, and throat synthetic polymer material
2
48 G.3695 下頷骨植入式臉部彌補物 Mandibular implant facial prosthesis 2 49 G.3730 喉部彌補物(Taub 式) Laryngeal prosthesis (Taub design) 2 50 G.3760 球囊切開術釘(Cody 氏釘) Sacculotomy tack (Cody tack) 2 51 G.3820 內淋巴液分流器 Endolymphatic shunt 2 52 G.3850 含瓣膜式內淋巴液分流導管 Endolymphatic shunt tube with
valve
2
53 G.3880 鼓室通氣管 Tympanostomy tube 2
54 G.3930 含半通透膜鼓室通氣管 Tympanostomy tube with semipermeable membrane
2
55 H.3350 膨脹式陰莖植入物 Penile inflatable implant 3 56 H.3630 硬式陰莖植入物 Penile rigidity implant 2 57 H.3750 睾丸彌補物 Testicular prosthesis 3 58 H.4620 輸尿管支架 Ureteral stent 2 59 H.5015 胰液引流支架與施放系統 Pancreatic drainage stent 2 60 H.5140 膀胱殘餘尿浄空用尿道置入
式幫浦
Urethral insert with pump for bladder drainage
2
61 H.5270 植入式電子排尿自制裝置 Implanted electrical urinary continence device
3
62 H.5280 植入式機械/水壓式排尿自 制裝置
Implanted mechanical/hydraulic urinary continence device
3
63 H.5530 植入式前列腺組織夾取系統 Implantable transprostatic tissue retractor system
2
64 H.5540 血液通路裝置及其附件 Blood access device and accessories 2 65 H.5930 女性下泌尿道症用直腸控制
系統 Rectal control system
2
66 I.0002 膠原蛋白植入劑 Collagen implant 3 67 I.0007 玻尿酸植入物 Hyaluronic Acid Implants 3 68 I.0010 抗沾黏屏障材料 Adhesion Barrier Material 3 69 I.3300 外科用網片 Surgical mesh 2 70 I.3500 含碳纖維合成物之聚四氟乙
烯之植入物材料
Polytetrafluoroethylene with carbon fibers composite implant material
2
71 I.3530 可充填生理食鹽水之矽膠乳
房彌補物 Silicone inflatable breast prosthesis 3
72 I.3540 矽膠充填之乳房彌補物 Silicone gel-filled breast prosthesis 3 73 I.3550 下巴彌補物 Chin prosthesis 2 74 I.3590 耳朵彌補物 Ear prosthesis 2 75 I.3610 食道彌補物 Esophageal prosthesis 2 76 I.3680 鼻彌補物 Nose prosthesis 2 77 I.3720 氣管彌補物 Tracheal prosthesis 2 78 I.4010 組織黏著劑 Tissue adhesive 2,3 79 I.4015 含聚二甲基二烯丙基氯化銨
(pDADMAC)成分之創傷覆 蓋材
Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive
2
80 I.4300 可植入式夾子 Implantable clip 2
81 I.4490 可吸收性止血劑及敷料 Absorbable hemostatic agent and dressing
3
82 I.4493 可吸收性多醣體交脂類外科 用縫合線
Absorbable poly(glycolide/L- lactide) surgical suture
2
83 I.4494 基因重組技術製造之可吸收 聚羥基丁酸酯外科縫線
Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology
2
84 I.4495 不銹鋼縫合線 Stainless steel suture 2 85 I.4520 聚四氟乙烯注射物 Polytetrafluoroethylene injectable 3 86 I.4750 植入式縫合釘 Implantable staple 2 87 I.4830 可吸收性腸縫合線 Absorbable surgical gut suture 2 88 I.4840 可吸收性聚對二氧環已酮外
科縫合線
Absorbable polydioxanone surgical suture
2
89 I.5000 不可吸收性聚對苯二甲酸乙 二酯縫合線
Nonabsorbable poly(ethylene terephthalate)surgical suture
2
90 I.5010 不可吸收性聚丙烯縫合線 Nonabsorbable polypropylene surgical suture
2
91 I.5020 不可吸收性聚醯胺縫合線 Nonabsorbable polyamide surgical suture
2
92 I.5030 不可吸收性絲縫合線 Natural nonabsorbable silk surgical suture
2
93 I.5035 非吸收式膨體聚四氟乙烯手 術縫合線
Nonabsorbable expanded polytetrafluoroethylene surgical suture
2
94 K.1330 深度電極 Depth electrode 2 95 K.5030 動脈瘤縫合術用甲基丙烯酸
甲酯
Methyl methacrylate for aneurysmorrhaphy
2
96 K.5150 血管內閉塞導管 Intravascular occluding catheter 3 97 K.5175 頸動脈夾 Cartoid artery clamp 2 98 K.5200 動脈瘤夾 Aneurysm clip 2 99 K.5225 植入式可展延夾 Implanted malleable clip 2
100 K.5275 神經環帶 Nerve cuff 2
101 K.5300 頭顱造型術用甲基丙烯酸甲
酯 Methyl methacrylate for cranioplasty
2
102 K.5320 預成形可變式頭顱造型板 Preformed alterable cranioplasty plate
2
103 K.5330 預成形不可變式頭顱造型板 Preformed nonalterable cranioplasty plate
2
104 K.5360 頭顱造形板固定器 Cranioplasty plate fastener 2 105 k.5805 重複式經顱磁刺激(rTMS)治
療系統
Repetitive transcranial magnetic stimulation system
2
106 K.5820 植入式小腦刺激器 Implanted cerebellar stimulator 3 107 K.5830 植入式膈膜/膈神經刺激器 Implanted diaphragmatic/phrenic
nerve stimulator
3
108 K.5840 疼痛舒緩用植入式大腦內/
皮質下刺激器
Implanted intracerebral/subcortical stimulator for pain relief
3
109 K.5850 膀胱排空用植入式脊髓刺激 器
Implanted spinal cord stimulator for bladder evacuation
3
110 K.5860 植入式神經肌肉刺激器 Implanted neuromuscular stimulator 3 111 K.5870 疼痛舒緩用植入式週邊神經
刺激器
Implanted peripheral nerve stimulator for pain relief
2
112 K.5880 疼痛舒緩用植入式脊髓刺激 器
Implanted spinal cord stimulator for pain relief
2,3
113 K.5900 預成形頭顱骨接合帶 Preformed craniosynostosis strip 2 114 K.5910 硬膜替代物 Dura substitute 2 115 K.5940 電痙攣治療裝置 Electroconvulsive therapy device 3 116 K.5950 人工栓塞裝置 Artificial embolization device 3 117 L.0004 可吸收性防沾黏材質 Absorable adhesion barrier 3 118 L.3650 輸卵管彌補物 Fallopian tube prosthesis 2 119 L.3900 陰道支架 Vaginal stent 2 120 L.5360 子宮內避孕器及放置器 Contraceptive intrauterine device
(IUD) and introducer
3
121 L.5380 輸卵管閉合避孕器及放置器 Contraceptive tubal occlusion device (TOD) and introducer
3
122 L.5980 經陰道骨盆腔器官脫垂治療 用手術網片
Surgical mesh for transvaginal pelvic organ prolapse repair
3
123 M.0002 囊袋環 Endocapsular ring 3 124 M.3100 眼科用鉭製夾 Ophthalmic tantalum clip 2 125 M.3300 可吸收之植入物(鞏膜扣環
法)
Absorbable implant (scleral buckling method)
2
126 M.3320 眼球植入物 Eye sphere implant 2 127 M.3340 眼外部眼框植入物 Extraocular orbital implant 2 128 M.3400 角膜彌補物 Keratoprosthesis 2 129 M.3600 人工水晶體 Intraocular lens 3 130 M.3920 眼房水閥植入物 Eye valve implant 2
131 M.4155 鞏膜塞 Scleral plug 2 132 M.4270 眼內充填用氣體 Intraocular gas 3 133 M.4275 眼內充填用液體 Intraocular fluid 3 134 N.0003 關節腔玻尿酸植入物 Intraarticular hyaluronic acid
implants
3
135 N.3010 骨固定環 Bone fixation cerclage 2 136 N.3015 骨頭異體移植片 Bone heterograft 3 137 N.3020 骨髓內固定桿 Intramedullary fixation rod 2 138 N.3023 體內固化式髓內固定桿 In vivo cured intramedullary fixation
rod
2
139 N.3025 被動式肌腱彌補物 Passive tendon prosthesis 2 140 N.3027 PMMA 骨水泥 Polymethylmethacrylate (PMMA)
bone cement
2
141 N.3030 單一或多重之金屬類骨固定 裝置及附件
Single/multiple component metallic bone fixation appliance and accessories
2
142 N.3040 平滑或螺紋之金屬類骨固定 物
Smooth or threaded metallic bone fixation fastener
2
143 N.3045 可吸收鈣鹽骨洞填充裝置 Resorbable calcium salt bone void filler device
2,3
144 N.3050 椎弓板間之脊椎矯正固定物 Spinal interlaminal fixation orthosis 2 145 N.3060 椎體間之脊椎矯正固定物 Spinal intervertebral body fixation
orthosis
2
146 N.3070 椎弓螺釘系統 Pedicle screw spinal system 2 147 N.3080 椎體間融合裝置 Intervertebral body fusion device 2,3 148 N.3100 半限制型踝關節之金屬類/
複合物類骨水泥式彌補物
Ankle joint metal/composite semi- constrained cemented prosthesis
2
149 N.3110 半限制型踝關節之金屬類/
聚合物類骨水泥式彌補物
Ankle joint metal/polymer semi- constrained cemented prosthesis
2
150 N.3120 非限制型踝關節之金屬類/
聚合物類骨水泥式彌補物
Ankle joint metal/polymer non- constrained cemented prosthesis
3
151 N.3150 限制型肘關節之金屬類/金 屬類或金屬類/聚合物類骨 水泥式彌補物
Elbow joint metal/metal or
metal/polymer constrained cemented prosthesis
2
152 N.3160 半限制型肘關節之金屬類/
聚合物類骨水泥式彌補物
Elbow joint metal / polymer semi- constrained cemented prosthesis
2
153 N.3170 肘關節橈骨(半肘)聚合物類 彌補物
Elbow joint radial (hemi-elbow) polymer prosthesis
2
154 N.3180 肘關節肱骨(半肘)金屬類無 骨水泥式彌補物
Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis
3
155 N.3200 限制型指關節之金屬類/金 屬類無骨水泥式彌補物
Finger joint metal / metal
constrained uncemented prosthesis 3
156 N.3210 限制型指關節之金屬類/金 屬類骨水泥式彌補物
Finger joint metal / metal constrained cemented prosthesis
3
157 N.3220 限制型指關節之金屬類/聚 合物類骨水泥式彌補物
Finger joint metal / polymer constrained cemented prosthesis
3
158 N.3230 限制型指關節之聚合物類彌 補物
Finger joint polymer constrained prosthesis
2
159 N.3300 限制型髖關節之金屬類骨水 泥式或無骨水泥式彌補物
Hip joint metal constrained cemented or uncemented prosthesis
3
160 N.3310 限制型髖關節之金屬類/聚 合物類骨水泥式或無骨水泥 式彌補物
Hip joint metal/polymer constrained cemented or uncemented prosthesis
2
161 N.3320 半限制型髖關節金屬類/金 屬類含骨水泥式髖臼窩組件 之彌補物
Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis
3
162 N.3330 半限制型髖關節金屬/金屬 類含非骨水泥式髖臼窩組件 之彌補物
Hip joint metal/metal semi- constrained, with an uncemented acetabular component, prosthesis
3
163 N.3340 半限制型髖關節金屬類/複 合物類骨水泥式彌補物
Hip joint metal/composite semi- constrained cemented prosthesis
2
164 N.3350 半限制型髖關節金屬類/聚 合物類骨水泥式彌補物
Hip joint metal/polymer semi- constrained cemented prosthesis
2
165 N.3353 半限制型髖關節之金屬類/
陶瓷類/聚合物類骨水泥或 無孔塗佈無骨水泥式彌補物
Hip joint metal / ceramic / polymer semi-constrained cemented or nonporous uncemented prosthesis
2
166 N.3358 半限制型髖關節金屬類/聚 合物類/金屬類多孔塗佈無 骨水泥式彌補物
Hip joint metal / polymer / metal semi-constrained porous-coated uncemented proshesis
2
167 N.3360 髖關節股骨(半髖)金屬骨水 泥或無骨水泥式彌補物
Hip joint femoral(hemi-hip) metallic cemented or uncemented prosthesis
2
168 N.3370 髖關節(半髖)髖臼金屬骨水 泥式彌補物
Hip joint (hemi-hip) acetabular metal cemented prosthesis
3
169 N.3380 髖關節股骨(半髖)骨幹軸承 金屬類/多縮醛類骨水泥式 彌補物
Hip joint femoral(hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
3
170 N.3390 髖關節股骨(半髖)金屬類/聚 合物類骨水泥或無骨水泥式 彌補物
Hip joint femoral(hemi-hip) metal/polymerl cemented or uncemented prosthesis
2
171 N.3400 髖關節股骨(半髖)金屬類重 鋪面骨彌補物
Hip joint femoral(hemi-hip) metallic resurfacing prosthesis
2
172 N.3410 半限制型髖關節金屬類/聚 合物類重鋪面式骨水泥彌補 物
Hip joint metal/polymer semi- constrained resurfacing cemented prosthesis
3
173 N.3480 限制型膝關節股脛骨金屬類 骨水泥式彌補物
Knee joint femorotibial metallic constrained cemented prosthesis
3
174 N.3490 非限制型膝關節股脛骨金屬 類/複合物類骨水泥式彌補 物
Knee joint femorotibial
metal/composite non-constrained cemented prosthesis
2
175 N.3500 半限制型膝關節股脛骨金屬 類/複合物類骨水泥式彌補 物
Knee joint femorotibial
metal/composite semi-constrained cemented prosthesis
2
176 N.3510 限制型膝關節股脛骨金屬類 /聚合物類骨水泥式彌補物
Knee joint femorotibial
metal/polymer constrained cemented prosthesis
2
177 N.3520 非限制型膝關節股脛骨金屬 類/聚合物類骨水泥式彌補 物
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
2
178 N.3530 半限制型膝關節股脛骨金屬 類/聚合物類骨水泥式彌補 物
Knee joint femorotibial
metal/polymer semi-constrained cemented prosthesis
2
179 N.3535 膝關節股脛骨(單側)金屬類/
聚合物類多孔塗佈無骨水泥 式彌補物
Knee joint femorotibial
unicompartmental metal/polymer porous-coated uncemented prosthesis
2
180 N.3540 半限制型膝關節臏股骨聚合 物類/金屬類骨水泥式彌補 物
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
2
181 N.3550 限制型膝關節臏股脛骨聚合 物類/金屬類/金屬類骨水泥 式彌補物
Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis
3
182 N.3560 半限制型膝關節臏股脛骨聚 合物類/金屬類/聚合物類骨 水泥式彌補物
Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis
2
183 N.3565 膝關節髕股骨金屬類/聚合 物類多孔塗佈無骨水泥式彌 補物
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
2
184 N.3570 膝關節股骨(半膝)金屬類無 骨水泥式彌補物
Knee joint femoral (hemi-knee) metallic uncemented prosthesis
3
185 N.3580 膝關節臏骨(半膝)金屬類重 鋪面無骨水泥式彌補物
Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
2,3
186 N.3590 膝關節脛骨(半膝)金屬類重 鋪面無骨水泥式彌補物
Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
2
187 N.3640 限制型肩關節金屬類/金屬 類或金屬類/聚合物類骨水 泥式彌補物
Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
3
188 N.3650 非限制型肩關節金屬類/聚 合物類骨水泥式彌補物
Shoulder joint metal / polymer non- constrained cemented prosthesis
2
189 N.3660 半限制型肩關節金屬類/聚 合物類骨水泥式彌補物
Shoulder joint metal/polymer semi- constrained cemented prosthesis
2
190 N.3670 肩關節金屬類/聚合物類非 限制型或半限制型多孔塗佈 無骨水泥式彌補物
Shoulder joint metal/polymer/metal nonconstrained or semiconstrained porous-coated uncemented prosthesis
2
191 N.3680 肩關節盂(半肩)金屬類骨水 泥式彌補物
Shoulder joint glenoid (hemi- shoulder)metallic cemented prosthesis
3
192 N.3690 肩關節肱骨(半肩)金屬類無 骨水泥式彌補物
Shoulder joint humeral (hemi- shoulder)metallic uncemented prosthesis
2
193 N.3720 限制型趾關節聚合物類彌補 物
Toe joint polymer constrained prosthesis
2
194 N.3730 趾關節趾骨(半趾)聚合物類 彌補物
Toe joint phalangeal (hemi- toe)polymer prosthesis
2
195 N.3750 腕關節腕半月骨聚合物類彌 補物
Wrist joint carpal lunate polymer prosthesis
2
196 N.3760 腕關節腕舟狀骨聚合物類彌 補物
Wrist joint carpal scaphoid polymer prosthesis
2
197 N.3770 腕關節腕多角骨聚合物類彌 補物
Wrist joint carpal trapezium polymer prosthesis
2
198 N.3780 限制型腕關節聚合物類彌補 物
Wrist joint polymer constrained prosthesis
2
199 N.3790 限制型腕關節金屬類骨水泥 式彌補物
Wrist joint metal constrained cemented prosthesis
3
200 N.3800 半限制型腕關節金屬類/聚 合物類骨水泥式彌補物
Wrist joint metal/polymer semi- constrained cemented prosthesis
2
201 N.3810 腕關節尺骨(半腕)聚合物類 彌補物
Wrist joint ulnar(hemi-wrist) polymer prosthesis
2
202 P.5725 可吸收式肛門直腸周邊阻隔
器 Absorbable perirectal spacer
2
