器械出口韩国应符合哪种KGMP体系？

编号

产品组

细分项

（代码+名称）

1

诊疗用普通设备 (General Equipment for Medical Treatment)

A01000 诊疗台和手术台

Operating and treatment table

A02000 医用床

Bed for medical use

A03000 医用照明设备

Medical light and lamps

A89000 牙科诊疗设备及椅子

Dental unit and chair

A89000 耳鼻喉科诊疗设备及椅子

Treatment table for Ear, Nose and Throat

A89000 眼科诊疗设备及椅子

Ophthalmic instrument table and chair

A04000 医用消毒设备

Medical sterilizing apparatus

A05000 医用无菌水设备

Medical water sterilizers

2

手术用设备 (Surgical Operation System)

A06000 麻醉机

Anesthesia apparatus

A39000 医用吸引器

Aspirators for medical use

A35000 电外科及其他手术设备

Electrosurgical and other surgical devices

A36000 冷冻手术设备

Cryosurgery device

A40000 气胸及腹膜腔设备

Pneumothorax and Premoperitoneum apparatus

3

激光手术设备 (Laser surgical devices)

A37000 激光诊疗设备

Laser apparatus for medical use

A15500 激光防护设备

Laser protective device

4

医用舱室 (Chamber for Medical Purpose)

A08000 医用舱室

Medical chamber

A34000 医用恒温器

Thermostats for medical use

5

生命维持设备 (Life Support System)

A07000 呼吸辅助设备 Respiratory apparatus

A10000 婴儿保育箱 Neonatal incubator

6

内脏功能替代设备(I) (Device for Replacing Function of Internal Organ(I))

A09000 内脏功能替代设备

Artificial internal organ apparatus

7

内脏功能替代设备(II) (Device for Replacing Function of Internal Organ(II))

A09000 内脏功能替代设备(3,4等级)

Artificial internal organ apparatus(3,4 class)

8

诊断用设备(I) (Diagnostic Imaging System(I))

A11000 诊断用X射线设备

Diagnostic X-ray system

A12000非电离诊断装置

Non-ionization diagnostic device

A13000 放射诊疗设备 Radiologic device

9

诊断用设备(II) (Diagnostic Imaging System(II))

A14000 医用胶片显影机

Film developer for medical use

A87000 医用胶片阅读设备

Film viewing devices for medical use

B01000 放射用品

Radiographic supplies

A15000 放射防护设备

Radiation protective device

10

物理诊疗设备(I) (Physical devices for medical use(I))

A16000 物理诊疗设备

Physical devices for medical use

11

物理诊疗设备(II) (Physical devices for medical use(II))

A16000 物理诊疗设备(3,4等级)

Physical devices for medical use(3,4 class)

12

医用电刺激发生设备 (Machine or Instrument for Generating Electric Stimulation, Medical Use)

A83000 个人用电刺激器 Electric stimulator for medical use by persona

A85000 医用磁感应设备 Magnetic induction apparatus for medical use

A67000 骨科及功能恢复设备 Medical device for orthopedics and restoration

A82000 医用振动器 Vibrators

13

心血管设备(I) (Cardiovascular devices(I))

A17000 心血管设备 Cardiovascular devices

14

心血管设备(II) (Cardiovascular devices(II))

A17000 心血管设备(3,4等级) Cardiovascular devices(3,4 class)

15

泌尿科设备(I) (Urology devices(I))

A18000 泌尿科设备 Urology devices

16

泌尿科设备(II) (Urology devices(II))

A18000 泌尿科设备(3,4等级) Urology devices(3,4 class)

17

组织处理设备 (Tissue processing device)

A33000 组织加工设备

Tissue processing device

A91000 医用细胞及组织处理设备

Medical cell and tissue processing device

18

结扎及缝合设备(I) (Instruments for ligature and suture(I))

A38000 结扎及缝合设备

Instruments for ligature and suture

19

结扎及缝合设备(II) (Instruments for ligature and suture(II))

A38000 结扎及缝合设备(3,4等级)

Instruments for ligature and suture(3,4 class)

20

患者转运车 (Patient Transport Vehicle)

A19000 患者转运车

Patient transport

21

医用探针(I) (Probe and Sound for medical use(I))

A58000 医用探针

Medical informant

22

医用探针(II) (Probe and Sound for medical use(II))

A58000 医用探针(3,4等级)

Medical informant(3,4 class)

23

生理现象监测设备(I) (Physiological Monitoring Device(I))

A20000 听诊器 Stethoscope

A21000 体温测量设备 Clinical thermometric system

A28000 眼科检查设备 Eye testing instruments

A29000 听力检查设备 Hearing testing instruments

B06000 视力表及色盲检查表 (1等级) Test chart for visual acuity and color blindness(1 class)

24

生理现象监测设备(II) (Physiological Monitoring Device(II))

A23000 血压检查或脉搏检查设备

Sphygmomanometers and sphygmographs

A25000 体液分析设备 (1等级)

Body fluid testing apparatus(1 class)

A26000 内脏功能检查设备

Visceral function testing instruments

A30000 知觉及身体诊断设备

Perception and organs diagnostic devices

A27000 呼吸功能检查设备

Respiratory function testing apparatus

25

测量及引导设备(I) (Measuring and introducing instrument(I))

A64000 测量及引导设备

Measuring and introducing instrument

26

测量及引导设备(II) (Measuring and introducing instrument(II))

A64000 测量及引导设备(4等级)

Measuring and introducing instrument(4 class)

27

医用窥镜(I) (Medical Speculum(I))

A31000 医用窥镜

Speculums for medical use

28

医用窥镜(II) (Medical Speculum(II))

A31000 医用窥镜(4等级)

Speculums for medical use(4 class)

29

医用处理设备(I) (Machine or Instrument for Medical Treatment(I))

A41000 医用刀

Knives for medical use

A4200医用剪刀

Scissors for medical use

A43000 医用刮匙

Curettes for medical use

A44000 医用夹

Clamp for medical use

A45000 医用钳

Forceps for medical use

A46000 医用锯

Saw for medical use

A47000 医用凿

Chisel for medical use

A48000 医用剥离器

Raspatories for medical use

A49000 医用锤

Mallet for medical use

A80000 疝气治疗设备

Hernia supporters

A62000 医用填充器

Filling instruments for medical use

A63000 医用压板

Depressors for medical use

30

医用处理设备(II) (Machine or Instrument for Medical Treatment(II))

A50000 医用锉

File for medical use

A51000 医用杠杆

Lever for medical use

A52000 医用套索

Snare for medical use

A55000 医用穿刺器、刮削器及穿孔器

Puncturing, abrasion, perforating instrument for medical use

A56000 伤口扩张或开孔设备

Wound retractors and speculums

A59000 医用扩张器

Dilator and expander for medical use

A60000 医用涂抹器

Applicator for medical use

A61000 混合及分配设备

Dispenser and Mixing instrument

A65000 医用冲洗器

Douche instruments for medical use

A81000 医用吸入器

Inhalators for medical use

31

注射器及注射针 (Syringe or Needle)

A53000 注射针及穿刺针 Needle for syringe and puncture

A54000 注射器 Syringes

A84000 针灸设备 Acupuncture and moxibustion apparatus

32

医用导管及体液引流管(I) (Tube and Catheter for medical use(I))

A57000 医用导管及体液引流管 Tube and Catheter for medical use

33

医用导管及体液引流管(II) (Tube and Catheter for medical use(II))

A57000 医用导管及体液引流管（3、4类） Tube and Catheter for medical use（3、4class）

34

采血或输血及活检设备(I) (Blood donor or transfusion and biopsy set(I))

A69000 采血或输血及活检设备 Blood donor or transfusion and biopsy set

35

采血或输血及活检设备(II) (Blood donor or transfusion and biopsy set(II))

A69000 采血或输血及活检设备(3,4等级) Blood donor or transfusion and biopsy set(3,4 class)

36

药品注入设备(I) (Infusion instruments(I))

A79000 药品注入设备 Infusion instruments

37

药品注入设备(II) (Infusion instruments(II))

A79000 药品注入设备(3,4等级) Infusion instruments(3,4 class)

38

牙科处理设备 (Machine or Device for Dental Treatment)

A69000 牙科引擎 Dental engine A70000 牙科钻 Broaches for dental use A71000 牙科探针 Explorers for dental use

A72000 牙科防潮设备 Moisture-excluding instruments for dental use

A73000 印模采集或咬合设备 Impression taking and articulating instruments

A74000 牙科聚合器 Vulcanizers and curing units for dental use

39

视力矫正眼镜 (Sight corrective spectacles)

A76000 视力矫正眼镜 Sight corrective spectacles

40

眼科用镜片(I) (Ophthalmic lens(I))

A77000 眼科用镜片 Ophthalmic lens

41

眼科用镜片(II) (Ophthalmic lens(II))

A77000 眼科用镜片(3,4等级) Ophthalmic lens(3,4 class)

42

助听器 (Hearing Aid)

A78000 助听器 Hearing Aid

43

医用物质生成设备 (Equipment Generating Medical Substance)

A86000 医用物质生成设备 Medicinal substance-producing equipment

44

缝合线及结扎线(I) (Suture and ligature)

B02000 缝合线及结扎线 Suture and ligature

45

缝合线及结扎线(II) (Suture and ligature)

B02000 缝合线及结扎线（3、4类） Suture and ligature（3、4class）

46

骨科用品I(关节类等) (Orthopedic materials(Internal total etc))

B03000 骨科用品, B03410.01(骨科用品II(材料) 除外) Orthopedic materials(except for Orthopedic materials II)

47

骨科用品II(材料) (Orthopedic materials)

B03190, B03240, B03260, B03280~B03400

48

体内植入牙科用品 (Interbody Implants for Medical Purpose)

C18000 颌面整形材料 Maxillofacial Plastic Material

C19000 颌骨固定材料 Maxillary Bone Fixation Material

C21000 牙科植入手术设备 Implant, endosseous, hand instrument

49

牙科植入系统(I) (Dental Implant System(I))

C20000 牙科植入系统 Dental Implant System

50

牙科植入系统(II) (Dental Implant System(II))

C20000 牙科植入系统(3,4等级) Dental Implant System(3,4 class)

51

人体组织或功能替代品 (Substitute of Human Tissue or Body Function)

B04000 人体组织或功能替代品 Human tissue and organ substitute

52

牙科骨移植材料 (Dental Bone Graft Material)

C22000 牙科骨移植材料 Dental Bone Graft Material

53

牙周组织再生诱导材料 (Guided Bone and Tissue Regeneration Material)

C23000 牙周组织再生诱导材料 Guided Bone and Tissue Regeneration Material

54

夹板 (Splints)

B05000 夹板 Splints

55

外科用品 (Surgical supplies)

B07000 外科用品(伤口覆盖材料除外) Surgical supplies

56

伤口覆盖材料 (Dressing)

B07070 伤口覆盖材料 Dressing

57

避孕套 (Condom)

B08000 避孕套 Condom

58

避孕设备 (Contraceptive device)

B09000 避孕设备 Contraceptive device

59

牙科合金 (Dental Alloy)

C01000 牙科加工用合金 Dental Processing Alloy

C02000 牙科铸造合金 Dental Casting alloy

C03000 金属陶瓷合金 Metal-Ceramic Alloy

C04000 钎焊合金 Soldering Alloy

C05000 加工用合金 Fabricated Alloy

60

牙科处理材料 (Other Materials for Dental Treatment)

C06000 直接修复材料 Direct Restorative Material

C07000 美学修复材料 Esthetic Prosthetic Material

C08000 义齿材料 Denture Making Material/Denture Material

C09000 义齿基托材料 Denture base material

C11000 牙科粘接用水泥 Dental Adhesive Cement

C12000 牙科粘接剂 Dental Bonding Agent

C10000 根管治疗材料 Material For Root Canal Therapy

C13000 牙科印模材料 Dental Impression Material

C14000 牙科蜡 Dental Wax

C16000 预防牙科材料 Preventive Dental Material

C17000 牙科矫正材料 Orthodontic Material

C24000 牙科诊断剂 Dental diagnosis Material

C25000 修复物分离材料 Prosthetic Adhesive Remover

C26000 其他修复材料 Other Prosthetic Material

C27000 其他保存材料 Other Restorative-Endodontic Material

61

泛在医疗设备(I) (Medical Device for Ubiquitous Healthcare(I))

A90000 泛在医疗设备 Medical Device for Ubiquitous Healthcare

62

泛在医疗设备(II) (Medical Device for Ubiquitous Healthcare(II))

A90000 泛在医疗设备(3,4等级) Medical Device for Ubiquitous Healthcare

63

创新医疗设备软件

「医疗器械产业法」第24条(创新医疗设备软件特例) 适用医疗器械

64

软件 (Software)

E01000 心血管诊疗软件 Software for cardiovascular

E02000 牙科诊疗软件 Software for dental

E03000 耳鼻喉科诊疗软件 Software for otolaryngology

E04000 胃肠病学及泌尿科诊疗软件 Software for gastroenterology and urology

 E05000 医院诊疗软件 Software for general hospital

E06000 神经科学诊疗软件 Software for neurology

E07000 妇产科诊疗软件 Software for uterology

E08000 眼科诊疗软件 Software for ophthalmology

E09000 骨科诊疗软件 Software for orthopaedics

E10000 康复医学诊疗软件 Software for rehabilitation

E11000 放射肿瘤学及影像医学诊疗软件 Software for radiation oncology and diagnostic radiology