China starts to implement UDI for certain Implantable Devices

On October 15th, 2019, Chinese National Medical Product Administration (NMPA) announced 64 types of medical devices required for the UDI implantation. All of them are classified as class III.

Those devices listed shall be produced with UDI after October 1st, 2020. The devices that are manufactured before October 1st, 2020 can be exempted from the UDI label. The UDI information must be uploaded into the national UDI database, which is still in the development phase.

The complete list of medical devices is given as below:

Category codeCategory level IProduct Name (CN)Product name (EN)
01.05.02Active Surgery Device02冷冻消融针及导管Cryoablation needle and catheter
02.13.06Non-active Surgery Device06 可吸收缝合线Absorbable sutures
03.13.01Neurological and vascular surgery device01造影导管01 Angiography catheter
03.13.02Neurological and vascular surgery device02导引导管02 Guide catheter
03.13.03Neurological and vascular surgery device03中心静脉导管03 Central venous catheter
03.13.05Neurological and vascular surgery device05灌注导管05 Perfusion catheter
03.13.06Neurological and vascular surgery device06球囊扩张导管06 Balloon dilating catheter
03.13.07Neurological and vascular surgery device07切割球囊07 Cutting balloon
03.13.08Neurological and vascular surgery device08造影球囊08 Radiography balloon
03.13.09Neurological and vascular surgery device09封堵球囊09 Blocking balloon
03.13.10Neurological and vascular surgery device10血栓抽吸导管10 Thrombus suction catheter
03.13.11Neurological and vascular surgery device11套针外周导管11 Trochar peripheral catheter
03.13.16Neurological and vascular surgery device16导丝16 Guidewire
03.13.20Neurological and vascular surgery device20心脏封堵器装载器20 Heart occluder loader
03.13.21Neurological and vascular surgery device21心脏封堵器输送线缆21 Heart occluder delivery cable
03.13.22Neurological and vascular surgery device22血管内回收装置22 Intravascular recovery device
06.14.04Medical Imaging Device04胶囊式内窥镜系统04 Capsule-type endoscope system
10.04.01Blood Transfusion, Dialysis and Extracorporeal Circulation Device01血液透析器具01 Blood dialysis apparatus
10.06.01Blood Transfusion, Dialysis and Extracorporeal Circulation Device01氧合器01 Oxygenator
10.06.03Blood Transfusion, Dialysis and Extracorporeal Circulation Device03微栓过滤器03 Microemboli filter
12.01.01Active Implantable Device01植入式心脏起搏器01 Implantable pacemakers
12.01.02Active Implantable Device02植入式心律转复除颤器02 Implantable cardioverter defibrillators
12.01.03Active Implantable Device03临时起搏器03 Temporary pacemakers
12.01.04Active Implantable Device04植入式心脏起搏电极导线04 Implantable cardiac pacing electrode lead
12.01.05Active Implantable Device05植入式心脏除颤电极导线05 Implantable cardiac defibrillation leads
12.01.06Active Implantable Device06临时起搏电极导线06 Temporary pacing electrode lead
12.01.07Active Implantable Device07植入式心脏事件监测设备07 Implantable cardiac event monitoring equipment
12.02.01Active Implantable Device01植入式神经刺激器01 Implantable nerve stimulators
12.02.02Active Implantable Device02植入式神经刺激电极02 Implantable nerve stimulation electrodes
12.02.04Active Implantable Device04神经调控充电设备04 Nerve controlled charging equipment
12.03.01Active Implantable Device01植入式位听觉设备01 Implantable hearing devices
13.01.02Non-active Implanted Device02单/多部件可吸收骨固定器械02 Signle / multi-part absorbable bone fixation device
13.04.01Non-active Implanted Device01髋关节假体01 Hip joint prothesis
13.04.02Non-active Implanted Device02膝关节假体02 Knee joint prothesis
13.04.03Non-active Implanted Device03肩关节假体03 Shoulder joint prothesis
13.04.04Non-active Implanted Device04肘关节假体04 Elbow joint prothesis
13.04.05Non-active Implanted Device05指关节假体05 Knuckle prothesis
13.04.06Non-active Implanted Device06腕关节假体06 Wrist joint prothesis
13.04.07Non-active Implanted Device07踝关节假体07 Angle joint prothesis
13.04.08Non-active Implanted Device08颞下颌关节假体08 Temporal- mandibular joint prothesis
13.06.04Non-active Implanted Device04硬脑(脊)膜补片04 Dura(spinal) patch
13.06.06Non-active Implanted Device06颅内支架系统06 Intracranial stent system
13.06.07Non-active Implanted Device07颅内栓塞器械07 Cranial embolism device
13.06.08Non-active Implanted Device08颅内弹簧圈系统08 Intracranial coils system
13.06.09Non-active Implanted Device09人工颅骨09 Artificial cranial bone
13.06.10Non-active Implanted Device10脑积水分流器及组件10 Hydrocephalus diverter and accessories
13.06.11Non-active Implanted Device11颅内动脉瘤血流导向装置11 Blood guiding device for intracranial arterial aneurysm
13.07.01Non-active Implanted Device01血管内假体01 Intravascular prothesis
13.07.02Non-active Implanted Device02血管支架02 Vascular stent
13.07.03Non-active Implanted Device03腔静脉滤器03 Vena caval filter
13.07.04Non-active Implanted Device04人工血管04 Vascular prosthesis
13.07.05Non-active Implanted Device05心血管补片05 Cardiovascular patch
13.07.06Non-active Implanted Device06人工心脏瓣膜及瓣膜修复器械06 Artificial cardiac valve and valve repair device
13.07.07Non-active Implanted Device07心脏封堵器07 Cardiac plugging device
13.07.08Non-active Implanted Device08心血管栓塞器械08 Cardiovascular embolism device
13.09.01Non-active Implanted Device01整形填充材料01 Plasticc filling materials
13.09.02Non-active Implanted Device02整形用注射填充物02 Plastic injection filler
13.09.03Non-active Implanted Device03乳房植入物03 Breast implant
13.09.04Non-active Implanted Device04外科补片/外科修补网04 Surgical patch/surgical repair mesh
13.09.06Non-active Implanted Device06非血管支架06 Non-vascular stent
13.09.07Non-active Implanted Device07支气管内活瓣07 Endobronchial valve
14.02.10Non-active Implanted Device10植入式给药器械Implantable drug administration devices
14.05.05Non-active Implanted Device05输尿管支架05 Ureter stent
16.07.01Ophthalmic Devices01人工晶状体01Intraocular lens

The original announcement by the NMPA is available in Chinese.