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