Guidelines for Specific Medical Devices (Continually Updated)

The NMPA (ex-CFDA) has also published lots of product-specific guidelines for technical review and clinical trials. JMedTec has summarized the complete list of all the guidelines as below.

Please use the product keywords to search whether any guidelines are relevant to your product. All the official guidelines are only available in Chinese. If you need a English version or detailed information, please feel free to contact us.

Update History of the Page

Mar/27/2019 Add all the product translation in English

Mar/03/2019 Generate the Information Page

Issued DateNotice No.Guideline typeProductProduct Chn.
Sep/04/2019No.59 in 2019For Technic Use (published version)Endometrial Radiofrequency Ablation Devices 子宫内膜射频消融设备(Chinese Version)
Jul/04/2019No.37 in 2019For Technic Use (published version)Intraoral Digital Impression Devices 口腔数字印模仪(Chinese Version)
Mai/22/2019No.25 in 2019For Technic Use (published version)Implantable Drug Delivery Devices 植入式给药装置(Chinese Version)
Mai/22/2019No.25 in 2019For Technic Use (published version)Intrauterine Devices 宫内节育器(Chinese Version)
Mai/22/2019No.25 in 2019For Technic Use (published version)Synthetic Resin Teeth合成树脂牙(Chinese Version)
Mai/15/2019No.24 in 2019For Clinical Trial (published version)Centrifugal Blood Components Separation Devices离心式血液成分分离设备(Chinese Version)
Mai/14/2019No.23 in 2019For Technic Use (published version)Service Life of Active Medical Devices有源医疗器械使用期限(Chinese Version)
Apr/19/2019No.18 in 2019For Technic Use (published version)Animal Studies for Medical Devices. Part I: Principles of Decision Making医疗器械动物实验研究技术审查指导原则 第一部分:决策原则 (Chinese Version)
Apr/19/2019No.18 in 2019For Technic Use (published version)Animal Testing for Abdominal Hernia Treatment Patches腹腔内置疝修补补片动物实验技术(Chinese Version)
Apr/11/2019No.16 in 2019For Technic Use (published version)Disposable Skin Staplers一次性使用皮肤缝合器(Chinese Version)
Apr/11/2019No.16 in 2019For Technic Use (published version)Dental Burs牙科车针(Chinese Version)
Apr/11/2019No.16 in 2019For Technic Use (published version)Disposable Dispensing Syringes一次性使用配药用注射器(Chinese Version)
Mar/26/2019No.10 in 2019For Clinical Trial (published version)Maxillofacial Cone Beam Computed Tomography Equipment口腔颌面锥形束计算机体层摄影设备(Chinese version)
Mar/26/2019No.10 in 2019For Technic Use (published version)Anesthesia Machine麻醉机(Chinese version)
Mar/26/2019No.10 in 2019For Technic Use (published version)Dual Energy X-Ray Bone Densitometer双能X射线骨密度仪(Chinese version)
Mar/26/2019No.19 in 2019For Technic Use (published version)Ophthalmic High Frequency Ultrasound Scanner眼科高频超声诊断仪(Chinese version)
Mar/20/2019No.13 in 2019For Clinical Trial (published version)Femtosecond Laser Instrument for Corneal Flap Surgery用于角膜制瓣的眼科飞秒激光治疗机 (Chinese version)
Mar/20/2019No.13 in 2019For Clinical Trial (published version)Sodium Hyaluronate Facial Injection Filling Material透明质酸钠类面部注射填充材料(Chinese version)
Mar/20/2019No.13 in 2019For Clinical Trial (published version)Intraocular Lens人工晶状体(Chinese version)
Mar/13/2019No.11 in 2019For Technic Use (published version)Procalcitonin Test Reagent降钙素原检测试剂(Chinese version)
Mar/13/2019No.11 in 2019For Technic Use (published version)Progesterone Test Reagent孕酮检测试剂(Chinese version)
Mar/13/2019No.11 in 2019For Technic Use (published version)Total Thyroxine Test Reagent总甲状腺素检测试剂(Chinese version)
Mar/13/2019No.11 in 2019For Technic Use (published version)Brain Natriuretic Peptide/N-terminal pro-Brain Natriuretic Peptide Test Reagent脑利钠肽/氨基末端脑利钠肽前体检测试剂(Chinese version)
Feb/25/2019No.8 in 2019For Clinical Trial (published version)Aortic Stent-Graft System主动脉覆膜支架系统(Chinese version)
Feb/25/2019No.8 in 2019For Clinical Trial (published version)Bioabsorbable Drug-eluting Coronary Artery Stents 生物可吸收冠状动脉药物洗脱支架(Chinese version)
Feb/25/2019No.8 in 2019For Clinical Trial (published version)Transcatheter Implanted Aortic Valve (TAVI)经导管植入式人工主动脉瓣膜(Chinese version)
Dec/24/2018No.130 in 2018For Technic Use (published version)Medical Laser Fiber医用激光光纤产品(Chinese version)
Dec/18/2018No.126 in 2018For Technic Use (published version)Single-use Biopsy Needles一次性使用活检针(Chinese version)
Dec/18/2018No.126 in 2018For Technic Use (published version)Disposable Bilirubin Adsorbent一次性使用胆红素血浆吸附器(Chinese version)\
Dec/04/2018No.120 in 2018For Technic Use (published version)Disposable Suction Tubes一次性使用吸痰管(Chinese version)
Dec/04/2018No.120 in 2018For Technic Use (published version)Staplers吻(缝)合产品(Chinese version)
Dec/04/2018No.120 in 2018For Technic Use (published version)Surgical Gauze外科纱布敷料(Chinese version)
Nov/13/2018No.116 in 2018For Technic Use (published version)Manual Wheelchairs手动轮椅车(Chinese version)
Nov/13/2018No.116 in 2018For Technic Use (published version)Zirconia Ceramic Block for Ceramic Dentures全瓷义齿用氧化锆瓷块(Chinese version)
Nov/13/2018No.116 in 2018For Technic Use (published version)Umbilical Belts护脐带(Chinese version)
Oct/30/2018No.107 in 2018For Technic Use (published version)Bone Cement Delivery System骨水泥套管组件(Chinese version)
Oct/30/2018No.107 in 2018For Technic Use (published version)Disposable Laryngeal Mask一次性使用医用喉罩(Chinese version)
Oct/30/2018No.107 in 2018For Technic Use (published version)Orthopedic External Fixation骨外科固定支架(Chinese version)
Oct/18/2018No.101 in 2018For Technic Use (published version)Medical Devices for Rare Disease Prevention and Treatment用于罕见病防治医疗器械
Sep/05/2018No.80 in 2018For Technic Use (published version)Custom Denture定制式义齿(Chinese version)
Sep/05/2018No.80 in 2018For Technic Use (published version)Disposable Urinary Catheter一次性使用无菌导尿管(Chinese version)
Sep/05/2018No.80 in 2018For Technic Use (published version)Nasogastric Intubation鼻饲营养导管(Chinese version)
Jun/29/2018No.51 in 2018For Clinical Trial (published version)Soft Contact Lenses 软性接触镜(Chinese version)
Jun/29/2018No.51 in 2018For Clinical Trial (published version)Rigid Contact Lenses角膜塑形用硬性透气接触镜(Chinese version)
Jun/11/2018No.40 in 2018For Clinical Trial (published version)Passive Implantable Medical Devices无源植入性医疗器械(Chinese version)
May/31/2018No.30 in 2018For Technic Use (published version)Anesthesia Laryngoscope麻醉咽喉镜(Chinese version)
May/31/2018No.30 in 2018For Technic Use (published version)Endoscope Reprocessing Devices内镜清洗消毒机(Chinese version)
May/31/2018No.30 in 2018For Technic Use (published version)Sleep-Breathing Monitor睡眠呼吸监测产品(Chinese version)
May/18/2018No.25 in 2018For Technic Use (published version)Operating Microscope手术显微镜(Chinese version)
May/18/2018No.25 in 2018For Technic Use (published version)Medical Clean Bench医用洁净工作台(Chinese version)
May/18/2018No.25 in 2018For Technic Use (published version)Tonometer眼压计(Chinese version)
May/18/2018No.25 in 2018For Technic Use (published version)Pulse Wave Velocity (PWV) and Ankle Brachial Index (ABI) 脉搏波速度和踝臂指数检测产品(Chinese version)
May/11/2018No.21 in 2018For Clinical Trial (published version)Coronary Drug-eluting Stent冠状动脉药物洗脱支架(Chinese version)
Apr/26/2018No.18 in 2018For Technic Use (published version)Assisted in Vitro Reproductive Technology人类体外辅助生殖技术用液(Chinese version)
Apr/20/2018No.15 in 2018For Technic Use (published version)Pneumoperitoneum Apparatus气腹机(Chinese version)
Apr/20/2018No.15 in 2018For Technic Use (published version)Medical Cryopreservation Storage System医用低温保存箱(Chinese version)
Apr/20/2018No.15 in 2018For Technic Use (published version)Electronic Urine Meter电子尿量计(Chinese version)
Apr/20/2018No.15 in 2018For Technic Use (published version)Digital Colposcope电子阴道显微镜(Chinese version)
Apr/16/2018No.9 in 2018For Technic Use (published version)Oral Panoramic X-ray Machine口腔曲面体层X射线机(Chinese version)
Mar/27/2018No.54 in 2018For Technic Use (published version)Rigid Optical Endoscope (Invasive Device)硬性光学内窥镜(有创类)(Chinese version)
Mar/21/2018No.56 in 2018For Technic Use (published version)Continuous Glucose Monitoring (CGM)持续葡糖糖监测系统(Chinese version)
Mar/21/2018No.57 in 2018For Technic Use (published version)Interferon Gamma Release Assay结合分歧杆菌特异性细胞免疫反应检测试剂(Chinese version)
Mar/20/2018No.55 in 2018For Technic Use (published version)Ophthalmic Ultrasound Imaging System眼科超声诊断设备(Chinese version)
Mar/02/2018No.44 in 2018For Technic Use (published version)Optical Coherence Tomography System眼科光学相干断层扫描仪(Chinese version)
Feb/24/2018No.37 in 2018For Technic Use (published version)Ultrasound Soft Tissue Cutting, Hemostatic System超声软组织切割止血系统(Chinese version)
Feb/24/2018No.36 in 2018For Technic Use (published version)Enteroviruses Nucleic Acid Detection Kits肠道病毒核酸检测试剂(Chinese version)
Feb/24/2018No.36 in 2018For Technic Use (published version)Direct Antiglobulin Test Kits抗人球蛋白检测试剂(Chinese version)
Feb/24/2018No.36 in 2018For Technic Use (published version)Helicobacter Pylori Antigen/Antibody Test Kits幽门螺杆菌抗原/抗体检测试剂(Chinese version)
Feb/24/2018No.36 in 2018For Technic Use (published version)Epidermal Growth Factor Receptor (EGFR) Detection Reagent人表皮生长因子受体(EGFR)突变基因检测试剂(PCR)法(Chinese version)
Feb/09/2018No.26 in 2018For Technic Use (published version)X-ray Computed Tomography SystemX射线计算机体层摄影设备(Chinese version)
Jan/16/2018No.8 in 2018For Technic Use (published version)Alanine Aminotransferase Test Kits丙氨酸氨基转移酶测定试剂(Chinese version)
Jan/16/2018No.8 in 2018For Technic Use (published version)Urine Analysis Test Kits尿液分析试纸条(Chinese version)
Jan/16/2018No.8 in 2018For Technic Use (published version)Homocysteine Test Kits同型半胱氨酸测定试剂(Chinese version)
Jan/16/2018No.8 in 2018For Technic Use (published version)Insulin Test Kits胰岛素测定试剂(Chinese version)
Jan/16/2018No.8 in 2018For Technic Use (published version)C- Peptide ELISA Test KitsC-肽测定试剂(Chinese version)
Jan/16/2018No.9 in 2018For Technic Use (published version)D-Dimer ELISA KitsD-二聚体测定试剂(Chinese version)
Jan/16/2018No.9 in 2018For Technic Use (published version)Apolipoprotein B Assay Kits载脂蛋白B测定试剂(Chinese version)
Jan/16/2018No.9 in 2018For Technic Use (published version)Apolipoprotein A1 Assay Kits载脂蛋白A1测定试剂(Chinese version)
Jan/11/2018No.13 in 2018For Clinical Trial (published version)Accepting Overseas Clinical Trial Data of Medical Devices接受医疗器械境外临床试验数据(Chinese version)
Jan/04/2018No.4 in 2018For Clinical Trial (published version)Proton/Carbon Ion Therapy System质子碳离子治疗系统(Chinese version)
Jan/04/2018No.3 in 2018For Technic Use (published version)Storage Bags for Whole Blood and Blood Components全血及血液成分贮存袋(Chinese version)
Jan/04/2018No.3 in 2018For Technic Use (published version)Disposable Infusion Pump (Non-electric)一次性使用输注泵(非电驱动)(Chinese version)
Jan/04/2018No.3 in 2018For Technic Use (published version)Hemoconcentrator血液浓缩器(Chinese version)
Jan/04/2018No.6 in 2018For Clinical Trial (published version)Clinical Trial Design for Medical Devices医疗器械临床试验设计(Chinese version)
Dec/29/2017No.222 in 2017For Technic Use (published version)Mobile Medical Devices移动医疗器械(Chinese version)
Dec/25/2017No.224 in 2017For Technic Use (published version)Medical Devices Containing Materials Derived from Animal Sources动物源性医疗器械(Chinese version)
Dec/22/2017No.213 in 2017For Technic Use (published version)Luteinizing Hormone Detection Reagent (Colloidal Gold Immune Chromatography)促黄体生成素检测试剂(胶体金免疫层析法)(Chinese version)
Dec/22/2017No.213 in 2017For Technic Use (published version)Cardiac Troponin I/ Myoglobin/ Creatine Kinase MB Assay Reagent (Colloidal Gold Immuno Chromatography)心肌肌钙蛋白I/肌红蛋白/肌酸激酶同工酶MB检测试剂(胶体金免疫层析法)(Chinese version)
Dec/22/2017No.213 in 2017For Technic Use (published version)Electrolyte Potassium, Sodium, Chlorine, Calcium Assay Reagent电解质钾、钠、氯、钙测定试剂(Chinese version)
Dec/22/2017No.213 in 2017For Technic Use (published version)High Density Lipoprotein Cholesterol Assay Reagent高密度脂蛋白胆固醇测定试剂(Chinese version)
Dec/22/2017No.213 in 2017For Technic Use (published version)Cystatin C Assay Reagent (Latex Transmitted Immuno Turbidimetry)胱抑素C测定试剂(胶乳透射免疫比浊法)(Chinese version)
Dec/22/2017No.209 in 2017For Technic Use (published version)Automatic Blood Type Analyzer全自动血型分析仪(Chinese version)
Dec/22/2017No.209 in 2017For Technic Use (published version)ABO, RhD Blood Group Reagent CardABO、RhD血型抗原检测卡(柱凝集法)(Chinese version)
Dec/22/2017No.209 in 2017For Technic Use (published version)Human Epidermal Growth Factor Receptor 2 Gene Amplification Test Kit人表皮生长因子受体2基因扩增检测试剂盒(荧光原位杂交法)(Chinese version)
Dec/22/2017No.209 in 2017For Technic Use (published version)Hepatitis C Virus Genotyping Assay Test Kit丙型肝炎病毒核酸基因分型检测试剂盒(Chinese version)
Dec/18/2017No.212 in 2017For Clinical Trial (published version)Therapeutic Ventilator治疗呼吸机临床评价(Chinese version)
Dec/18/2017No.212 in 2017For Clinical Trial (published version)Radiofrequency Endometrial Ablation Device子宫内膜去除(热传导、射频消融)设备(Chinese version)
Dec/18/2017No.216 in 2017For Technic Use (published version)Cell Therapeutic Product细胞治疗产品(Chinese version)
Dec/06/2017No.219 in 2017For Technic Use (published version)Microscope生物显微镜(Chinese version)
Dec/06/2017No.219 in 2017For Technic Use (published version)UV Treatment Device紫外治疗设备(Chinese version)
Dec/06/2017No.219 in 2017For Technic Use (published version)Slit-Lamp Microscope裂隙灯显微镜(Chinese version)
Dec/06/2017No.219 in 2017For Technic Use (published version)Infusion Pump输液泵(Chinese version)
Dec/06/2017No.219 in 2017For Technic Use (published version)Electric Gastric Lavage Machine电动洗胃机(Chinese version)
Dec/06/2017No.218 in 2017For Technic Use (published version)Small Stem Sterilizer小型蒸汽灭菌器(Chinese version)
Dec/06/2017No.218 in 2017For Technic Use (published version)Holter Monitoring System动态心电图系统(Chinese version)
Dec/06/2017No.218 in 2017For Technic Use (published version)Balloon Catheter Pump for Endovascular Catheter血管内球囊扩张导管用球囊充压装置(Chinese version)
Dec/06/2017No.218 in 2017For Technic Use (published version)Refractometer验光仪(Chinese version)
Dec/06/2017No.218 in 2017For Technic Use (published version)Central Monitoring Station Software中央监护软件(Chinese version)
Nov/14/2017No.177 in 2017For Technic Use (published version)Infrared Treatment Devices红外线治疗设备(Chinese version)
Nov/14/2017No.177 in 2017For Technic Use (published version)Temperature-control Blanket医用控温毯(Chinese version)
Nov/14/2017No.177 in 2017For Technic Use (published version)Electrotherapy Treatment中频电疗产品(Chinese version)
Nov/14/2017No.177 in 2017For Technic Use (published version)Pulse Oximeter脉搏血氧仪(Chinese version)
Nov/14/2017No.177 in 2017For Technic Use (published version)Dental Handpiece牙科手机(Chinese version)
Nov/06/2017No.180 in 2017For Technic Use (published version)Ultrasonic Bone Densitometer超声骨密度仪(Chinese version)
Nov/06/2017No.180 in 2017For Technic Use (published version)Electric Wheelchair电动轮椅车(Chinese version)
Nov/06/2017No.180 in 2017For Technic Use (published version)Clinical Infrared Ear Thermometer耳腔式医用红外体温计(Chinese version)
Nov/06/2017No.180 in 2017For Technic Use (published version)Medical Suction Equipment医用吸引设备(Chinese version)
Nov/06/2017No.180 in 2017For Technic Use (published version)Micromolecule Sieve Oxygen Concentrator小型分子筛制氧机(Chinese version)
Nov/02/2017No.177 in 2017For Technic Use (published version)Ultrasonic Doppler Fetal Monitor超声多普勒胎儿监护仪(Chinese version)
Nov/02/2017No.177 in 2017For Technic Use (published version)Ultrasonic Physiotherapy Equipment超声理疗设备(Chinese version)
Nov/02/2017No.177 in 2017For Technic Use (published version)Ultrasonic Dental Cleaning Equipment超声洁牙设备(Chinese version)
Nov/02/2017No.177 in 2017For Technic Use (published version)Ophthalmic Perimeters视野计(Chinese version)
Nov/02/2017No.177 in 2017For Technic Use (published version)Anti-decubitus Air Mattress防褥疮气床垫(Chinese version)
Oct/09/2017No.154 in 2017For Technic Use (published version)Microplate Reader酶标仪(Chinese version)
Oct/09/2017No.154 in 2017For Technic Use (published version)One-time Use ECG Electrodes一次性使用心电电极(Chinese version)
Oct/09/2017No.154 in 2017For Technic Use (published version)Dynamic Blood Pressure Monitor动态血压测量仪(Chinese version)
Oct/09/2017No.154 in 2017For Technic Use (published version)ECG Machine心电图机(Chinese version)
Oct/09/2017No.154 in 2017For Technic Use (published version)Patient Monitoring Devices病人监护产品(第二类)(Chinese version)
Sep/13/2017No.146 in 2017For Technic Use (published version)Infrared Mammography Equipment红外乳腺检查仪(Chinese version)
Sep/13/2017No.146 in 2017For Technic Use (published version)Medical Ozone Therapy Instrument医用臭氧妇科治疗仪(Chinese version)
Sep/13/2017No.146 in 2017For Technic Use (published version)Surgical Equipment for Osseous Tissue骨组织手术设备(Chinese version)
Aug/02/2017No.124 in 2017For Technic Use (published version)Dental Implant Equipment牙科种植机(Chinese version)
May/21/2017No.75 in 2017For Technic Use (published version)Passive Implantable Medical Devices Shelf无源植入性医疗器械货架(Chinese version)
Apr/24/2017No.60 in 2017For Technic Use (published version)Ultrasound Doppler Fetal Heart Rate Meter超声多普勒胎儿心率仪(Chinese version)
Apr/24/2017No.60 in 2017For Technic Use (published version)Electric Traction Device电动牵引装置(Chinese version)
Apr/24/2017No.60 in 2017For Technic Use (published version)Electric Operating Table电动手术台(Chinese version)
Apr/24/2017No.60 in 2017For Technic Use (published version)Class II Ultrasound Imaging Diagnostic Equipment影像型超声诊断设备(第二类)(Chinese version)
Apr/01/2017No.52 in 2017For Technic Use (published version)Fetal Chromosome Aneuploidy Test Kits胎儿染色体非整倍体(T21、T18、T13)检测试剂盒(高通量测序法(Chinese version)
Mar/29/2017No.23 in 2017For Technic Use (published version)Prosthetic Injectionof Artificial Cervical Disc人工颈椎间盘假体(Chinese version)
Mar/29/2017No.41 in 2017For Technic Use (published version)Surgical Electrode手术电极(Chinese version)
Mar/29/2017No.44 in 2017For Technic Use (published version)Polyurethane Foam Dressing Product聚氨酯泡沫敷料产品(Chinese version)
Mar/29/2017No.44 in 2017For Technic Use (published version)Dental Fiber Pile Products牙科纤维桩产品(Chinese version)
Mar/28/2017No.23 in 2017For Technic Use (published version)Prosthesis of Hip Joint髋关节假体系统(Chinese version)
Mar/28/2017No.25 in 2017For Technic Use (published version)Mycobacterium tuberculosis Complex Group Resistance Gene Mutation Detection Reagent结核分枝杆菌复合群耐药基因突变检测试剂(Chinese version)
Mar/28/2017No.30 in 2017For Technic Use (published version)Operation Lamps手术无影灯(Chinese version)
Mar/28/2017No.30 in 2017For Technic Use (published version)Laparoscopy Surgical Tools腹腔镜手术器械(Chinese version)
Mar/28/2017No.30 in 2017For Technic Use (published version)Electric Hospital Bed电动病床(Chinese version)
Mar/28/2017No.35 in 2017For Technic Use (published version)Cochlear Implant Systems人工耳蜗植入系统(Chinese version)
Mar/28/2017No.44 in 2017For Technic Use (published version)Endoscopic Stapler腔镜用吻合器产品(Chinese version)
Mar/28/2017No.13 in 2017For Technic Use (published version)Medical Devices Network Security医疗器械网络安全(Chinese version)
Mar/27/2017No.41 in 2017For Technic Use (published version)Semiconductor Laser Therapy Machine (Class II)半导体激光治疗机(第二类)(Chinese version)
Mar/27/2017No.41 in 2017For Technic Use (published version)Clinical Electronic Thermometer医用电子体温计(Chinese version)
Mar/27/2017No.41 in 2017For Technic Use (published version)Injection Pump注射泵(Chinese version)
Mar/16/2017No.40 in 2017For Technic Use (published version)Visible Spectrum Therapeutic Apparatus可见光谱治疗仪(Chinese version)
Mar/16/2017No.40 in 2017For Technic Use (published version)Flexible Fiber Endoscope (Class II)软性纤维内窥镜(第二类)(Chinese version)
Mar/16/2017No.40 in 2017For Technic Use (published version)Rigid Endoscope (Class II)硬管内窥镜(第二类)(Chinese version)
Feb/10/2017No.14 in 2017For Technic Use (published version)Calcium/Phosphate/Silicon Bone Filling Material钙磷/硅类骨填充材料(Chinese version)
Feb/10/2017No.14 in 2017For Technic Use (published version)Central Venous Catheters中心静脉导管产品(Chinese version)
Feb/10/2017No.14 in 2017For Technic Use (published version)Sock-Shaped Medical Pressure Belt袜型医用压力带(Chinese version)
Jan/16/2017No.6 in 2017For Clinical Trial (published version)Magnetic Resonance Imaging (MRI) Systems医用磁共振成像系统  (Chinese version)
Jan/16/2017No.6 in 2017For Technic Use (published version)External Defibrillation System体外除颤产品(Chinese version)
Jan/16/2017No.6 in 2017For Technic Use (published version)Oral Computer Tomography (CT)口腔颌面锥形束计算机体层摄影设备(Chinese version)
Jan/16/2017No.6 in 2017For Technic Use (published version)Light Curing Systems光固化机(Chinese version)
Jan/06/2017No.3 in 2017For Clinical Trial (published version)Cochlear Implant Systems人工耳蜗植入系统(Chinese version)
Dez/06/2016No.162 in 2016For Technic Use (published version)Anterior Vitrectomy & Phacoemulsification Devices眼科超声乳化和眼前节玻璃体切除设备(Chinese version)
Nov/02/2016No.146 in 2016For Technic Use (published version)One Time Usage Hemodialysis Tubing一次性使用血液透析管路(Chinese version)
Sep/30/2016No.131 in 2016For Technic Use (published version)Reagent Kit for ABO Reverse Grouping (Human Red Blood Cells)人红细胞反定型试剂(Chinese version)
Apr/26/2016No.70 in 2016For Technic Use (published version)Dental Implants牙科种植体(系统)(Chinese version)
Apr/26/2016No.70 in 2016For Technic Use (published version)Dental Base Polymer Material牙科基托聚合物材料(Chinese version)
Apr/26/2016No.70 in 2016For Technic Use (published version)Disposable Hydrocephalus Shunts一次性使用脑积水分流器(Chinese version)
Apr/26/2016No.70 in 2016For Technic Use (published version)Resorbable Surgical Suture Product可吸收性外科缝线(Chinese version)
Apr/26/2016No.70 in 2016For Technic Use (published version)Posterior Spinal Fixation System脊柱后路内固定系统 (Chinese version)
Apr/26/2016No.70 in 2016For Technic Use (published version)Interbody Fusion Cage椎间融合器(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)β2- microglobulin Assay Kit (Latex Enhanced Turbidimetric Immunoassay)β2-微球蛋白检测试剂盒(胶乳增强免疫比浊法)(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)Triglyceride Assay Kit甘油三酯测定试剂盒(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)Sialic Acid Assay Kit (Enzymatic)唾液酸检测试剂盒(酶法)(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)Thyrotropin Detection Assay Reagents促甲状腺素检测试剂(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)Lactate Dehydrogenase Assay Kit乳酸脱氢酶测定试剂盒(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)Glycated Hemoglobin Assay Kit (Enzymatic)糖化血红蛋白测定试剂盒(酶法)(Chinese version)
Apr/17/2016No.29 in 2016For Technic Use (published version)Albumin Assay Reagents (Kit)白蛋白测定试剂(盒)(Chinese version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Automatic Urine Sediment Analyzer自动尿液有形成分分析仪(Chinese version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Audiphone助听器(Chinese version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Medical Nebulizer医用雾化器
Apr/06/2016No.22 in 2016For Technic Use (published version)Dental Treatment Device牙科综合治疗机(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Water Device for Hemodialysis血液透析用制水设备(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Blood Glucose Monitor血糖仪(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Biomedical Analyzer生化分析仪(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Coagulation Analyzer凝血分析仪(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Semi-auto Chemiluminescence Immunoassay Analyzer半自动化学发光免疫分析仪(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Urine Analyzer尿液分析仪(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Class II X-ray Diagnostic DeviceX射线诊断设备 (第二类)(Chinese Version)
Apr/06/2016No.22 in 2016For Technic Use (published version)Electronic Sphygmomanometer电子血压计(示波法)
Apr/06/2016No.22 in 2016For Technic Use (published version)Magnetic Therapy Device磁疗产品(Chinese Version)
Apr/05/2016No.21 in 2016For Technic Use (published version)Therapeutic Ventilator治疗呼吸机(Chinese Version)
Apr/05/2016No.21 in 2016For Technic Use (published version)Intensive Pulse Light Therapeutic Apparatus强脉冲光治疗仪(Chinese Version)
Apr/05/2016No.21 in 2016For Technic Use (published version)Pulse Oximeter Equipment脉搏血氧仪设备(Chinese Version)
Apr/05/2016No.21 in 2016For Technic Use (published version)Implantable Cardiac Pacemaker植入式心脏起搏器(Chinese Version)
Apr/05/2016No.21 in 2016For Technic Use (published version)Medical X-ray Diagnostic Equipment (Class III)医用X射线诊断设备(第三类)(Chinese Version)
Apr/05/2016No.21 in 2016For Technic Use (published version)High Frequency Operation Equipment高频手术设备(Chinese Version)
Apr/05/2016No.7 in 2016For Technic Use (published version)Facial Injections of Sodium Hyaluronate Filling Material透明质酸钠类面部注射填充材料(Chinese Version)
Apr/05/2016No.7 in 2016For Technic Use (published version)Abdominal, Pelvic Surgery with Absorbable Anti-adhesion Products腹腔、盆腔外科手术用可吸收防粘连产品(Chinese Version)
Apr/05/2016No.7 in 2016For Technic Use (published version)Absorbable Hemostatic Product可吸收止血产品(Chinese Version)
Apr/05/2016No.6 in 2016For Technic Use (published version)α- cyanoacrylate Medical Adhesiveα-氰基丙烯酸酯类医用粘合剂(Chinese Version)
Apr/05/2016No.6 in 2016For Technic Use (published version)Disposable Membrane Oxygenator一次性使用膜式氧合器(Chinese Version)
Mar/07/2016No.28 in 2016For Technic Use (published version)Ischemia Modified Albumin Assay Kit缺血修饰白蛋白测定试剂盒(Chinese Version)
Mar/07/2016No.27 in 2016For Technic Use (published version)Medical Image Archiving and communication software (PACS)医学图像存储传输软件(PACS)(Chinese Version)
Mar/07/2016No.27 in 2016For Technic Use (published version)Positive Airway Pressure Device正压通气治疗机(Chinese Version)
Mar/07/2016No.27 in 2016For Technic Use (published version)Large Steam Sterilizers大型蒸汽灭菌器(Chinese Version)
Mar/07/2016No.27 in 2016For Technic Use (published version)Peritoneal Dialysis Machine腹膜透析机(Chinese Version)
Mar/07/2016No.27 in 2016For Technic Use (published version)Medical Endoscope Cold Light Source医用内窥镜冷光源(Chinese Version)
Mar/07/2016No.27 in 2016For Technic Use (published version)Tapping Machine Vibration Expectoration振动叩击排痰机(Chinese Version)
Mar/07/2016No.28 in 2016For Technic Use (published version)Alkaline Phosphatase Assay Kit碱性磷酸酶测定试剂盒(Chinese Version)
Mar/07/2016No.28 in 2016For Technic Use (published version)Human Chorionic Gonadotropin Detection Reagent (GICA method)人绒毛膜促性腺激素检测试剂(胶体金免疫层析法)(Chinese Version)
Mar/07/2016No.28 in 2016For Technic Use (published version)C-reaction Protein Assay KitC反应蛋白测定试剂盒(Chinese Version)
Mar/07/2016No.28 in 2016For Technic Use (published version)Fecal Occult Blood (FOB) Assay Kit (Colloidal Gold Immune Chromatography)大便隐血(FOB)检测试剂盒(胶体金免疫层析法)(Chinese Version)
Mar/07/2016No.28 in 2016For Technic Use (published version)Creatine Kinase Assay Kit肌酸激酶测定试剂(盒)(Chinese Version)
Apr/05/2015No.93 in 2016For Technic Use (published version)Automatic Chemiluminescence Immunoassay Analyzer全自动化学发光免疫分析仪(Chinese Version)
Apr/05/2015No.93 in 2016For Technic Use (published version)Human Papilloma Virus (HPV) Nucleic Acid Detection and Genotyping Reagent人乳头瘤病毒(HPV)核酸检测及基因分型试剂(Chinese Version)
Apr/05/2015No.93 in 2016For Technic Use (published version)Allergen-specific IgE Antigen/Antibody Detection Reagent过敏原特异性IgE抗体检测试剂(Chinese Version)
Apr/05/2015No.93 in 2016For Technic Use (published version)Hepatitis C Virus RNA Detection Reagent丙型肝炎病毒核糖核酸测定试剂(Chinese Version)
Apr/05/2015No.65 in 2016For Technic Use (published version)Mycobacterium tuberculosis Complex Group Nucleic Acid Detection Reagent结核分枝杆菌复合群核酸检测试剂(Chinese Version)
Apr/01/2015No.112 in 2015For Technic Use (published version)Image Ultrasonic Diagnostic Equipment (Class III)影像型超声诊断设备(第三类)(Chinese Version)
Apr/01/2015No.112 in 2015For Technic Use (published version)Centrifugal Blood Components Separation Device离心式血液成分分离设备(Chinese Version)
Apr/01/2015No.112 in 2015For Technic Use (published version)Proton/Carbon Ion Therapy System质子/碳离子治疗系统(Chinese Version)
Apr/01/2015No.32 in 2015For Technic Use (published version)Hepatitis B Virus Genotyping Detection Reagent乙型肝炎病毒基因分型检测试剂(Chinese Version)
Apr/01/2015No.33 in 2015For Technic Use (published version)Image Ultrasonic Diagnostic Equipment New Technology影像型超声诊断设备新技术(Chinese Version)
Apr/01/2015No.50 in 2015For Technic Use (published version)Medical Device Software医疗器械软件(Chinese Version)
Apr/01/2015No.11 in 2015For Technic Use (published version)Estrogen Receptor, Progesterone Receptor Antibody Reagent and Detection Kits雌激素受体、孕激素受体抗体试剂及检测试剂盒(Chinese Version)
Apr/01/2015No.14 in 2015For Clinical Trial (published version)Clinical Evaluation of Medical Device医疗器械临床评价(Chinese Version)
Sep/11/2014No.16 in 2015For Technic Use (published version)In Vitro Diagnostics Reagent体外诊断试剂临床试验(Chinese Version)
Sep/11/2014No.17 in 2015For Technic Use (published version)Compilation of In Vitro Diagnostic Reagent Manuals体外诊断试剂说明书编写(Chinese Version)
May/30/2014No.9 in 2014For Technic Use (published version)Technical Requirements on the Preparation of Medical Devices医疗器械产品技术要求(Chinese Version)
Apr/17/2014No.3 in 2014For Technic Use (published version)Hard Contact Lenses硬性角膜接触镜(Chinese Version)
Apr/17/2014No.3 in 2014For Technic Use (published version)Soft Contact Lenses软性亲水接触镜(Chinese Version)
Mar/31/2014No.10 in 2014For Technic Use (published version)Implantable cardiac electrode lead products植入式心脏电极导线产品(Chinese Version)
Mar/29/2014No.2 in 2014For Technic Use (published version)Drug Abuse Detection Reagent药物滥用检测试剂(Chinese Version)
Mar/29/2014No.2 in 2014For Technic Use (published version)Tumor Individualized Treatment Related Gene Mutation Detection Reagent肿瘤个体化治疗相关基因突变检测试剂(Chinese Version)
Mar/29/2014No.2 in 2014For Technic Use (published version)Toxoplasma Gondii, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus Antibody and G-type Immunoglobulin Antibody Affinity Detection Reagent弓形虫、风疹病毒、巨细胞病毒、单纯疱疹病毒抗体及G型免疫球蛋白抗体亲合力检测试剂(Chinese Version)
Mar/29/2014No.6 in 2014For Technic Use (published version)Metal Plate Internal Fixation System Products金属接骨板内固定系统产品(Chinese Version)
Mar/29/2014No.6 in 2014For Technic Use (published version)Hemodialysis Concentrate Product血液透析浓缩物产品(Chinese Version)
Mar/29/2014No.6 in 2014For Technic Use (published version)One Time Usage Lucifugar Insufflator一次性使用避光输液器产品(Chinese Version)
Mar/29/2014No.6 in 2014For Technic Use (published version)One Time Usage Blood Components Separation Device Products一次性使用血液分离器具产品(Chinese Version)
Mar/29/2014No.6 in 2014For Technic Use (published version)Dental Resin Filling Material Products牙科树脂类充填材料产品(Chinese Version)
Mar/29/2014No.5 in 2014For Technic Use (published version)Cardiac Radiofrequency Ablation Catheter Products心脏射频消融导管产品(Chinese Version)
Mar/29/2014No.7 in 2014For Technic Use (published version)One Time Usage Skin Stapler Products一次性使用皮肤缝合器产品(Chinese Version)
Mar/29/2014No.7 in 2014For Technic Use (published version)One Time Usage Drainage Tube Products一次性使用引流管产品(Chinese Version)
Mar/29/2014No.7 in 2014For Technic Use (published version)Medical Mask Products医用口罩产品(Chinese Version)
Oct/23/2013No.8 in 2013For Technic Use (published version)One Time Usage Nasal Oxygen Tube Products一次性使用鼻氧管产品(Chinese Version)
Oct/23/2013No.8 in 2013For Technic Use (published version)Alloy Products for Denture Production义齿制作用合金产品(Chinese Version)
Oct/23/2013No.8 in 2013For Technic Use (published version)One Time Usage Dispensing Syringe Products一次性使用配药用注射器产品(Chinese Version)
Oct/23/2013No.8 in 2013For Technic Use (published version)Sterile Surgical Kits Products一次性使用无菌手术包类产品(Chinese Version)
Oct/23/2013No.8 in 2013For Technic Use (published version)Negative Pressure Drainage Device Products负压引流装置产品(Chinese Version)
Mar/29/2013No.3 in 2013For Technic Use (published version)Flow Cytometry Detection Reagent流式细胞仪配套用检测试剂(Chinese Version)
Mar/29/2013No.3 in 2013For Clinical Trial (published version)Human Immunodeficiency Virus(HIV) Detection Reagent人类免疫缺陷病毒检测试剂(Chinese Version)
Mar/29/2013No.3 in 2013For Technic Use (published version)Pathogen-specific M-type Immunoglobulin Qualitative Detection Reagent病原体特异性M型免疫球蛋白定性检测试剂(Chinese Version)
Mar/29/2013No.3 in 2013For Technic Use (published version)Hepatitis B Virus DNA Quantitative Detection Reagent乙型肝炎病毒脱氧核糖核酸定量检测试剂(Chinese Version)
Mar/28/2013No.7 in 2013For Technic Use (published version)Hernia Repair Patch Products疝修补补片产品(Chinese Version)
Jan/04/2013No.3 in 2013For Technic Use (published version)One Time Usage Dialyzer Products一次性使用透析器产品(Chinese Version)
Jan/04/2013No.3 in 2013For Technic Use (published version)Biochip-based Detection Reagent生物芯片类检测试剂(Chinese Version)
Jan/04/2013No.3 in 2013For Technic Use (published version)Gold-labeled Detection Reagent金标类检测试剂(Chinese Version)
Jan/04/2013No.3 in 2013For Technic Use (published version)Nucleic Acid Amplification Assay Detection Reagent核酸扩增法检测试剂(Chinese Version)
Jan/04/2013No.3 in 2013For Technic Use (published version)Luminescent Immunoassay Reagent发光免疫类检测试剂(Chinese Version)
Jan/04/2013No.3 in 2013For Technic Use (published version)Enzyme-linked Immunosorbent Assay (ELISA) Detection Reagent酶联免疫法检测试剂(Chinese Version)
May/10/2012No.210 in 2012For Technic Use (published version)Zirconia Porcelain Products for All-ceramic Dentures全瓷义齿用氧化锆瓷块产品(Chinese Version)
May/10/2012No.210 in 2012For Technic Use (published version)Breathing Line Products for Anesthesia Machines and Ventilators麻醉机和呼吸机用呼吸管路产品(Chinese Version)
May/10/2012No.210 in 2012For Technic Use (published version)Surgical Power Equipment Products手术动力设备产品(Chinese Version)
Dec/23/2011No.540 in 2011For Technic Use (published version)Influenza Virus Antigen Detection Reagent流行性感冒病毒抗原检测试剂(Chinese Version)
Dec/23/2011No.540 in 2011For Technic Use (published version)Influenza Virus Nucleic Acid Detection Reagent流行性感冒病毒核酸检测试剂(Chinese Version)
May/11/2011No.187 in 2011For Technic Use (published version)One Time Usage Surgical Gown Products一次性使用手术衣产品(Chinese Version)
May/11/2011No.187 in 2011For Technic Use (published version)Natural Latex Rubber Condom Products天然胶乳橡胶避孕套产品(Chinese Version)
May/11/2011No.187 in 2011For Technic Use (published version)Custom Denture Products定制式义齿产品(Chinese Version)
May/11/2011No.187 in 2011For Technic Use (published version)One Time Usage Vacuum Blood Collection Tube Products一次性使用真空采血管产品(Chinese Version)
May/11/2011No.187 in 2011For Technic Use (published version)3A Semiconductor Laser Treatment Machine Products3A类半导体激光治疗机产品(Chinese Version)
Mar/24/2011No.116 in 2011For Technic Use (published version)Breast Implant Products乳房植入体产品(Chinese Version)
Mar/24/2011No.116 in 2011For Technic Use (published version)Care Products for Contact Lens接触镜护理产品(Chinese Version)
Mar/24/2011No.116 in 2011For Technic Use (published version)Viral Inactivation Process for Allogeneic Implantable Medical Device 同种异体植入性医疗器械病毒灭活工艺(Chinese Version)
Mar/24/2011No.116 in 2011For Technic Use (published version)One Time Usage Infusion Device Products一次性使用输注器具产品(Chinese Version)
Mar/24/2011No.116 in 2011For Technic Use (published version)Tumor Marker Quantitative Detection Reagent肿瘤标志物类定量检测试剂(Chinese Version)
Oct/18/2010No.438 in 2010For Technic Use (published version)Self-test Blood Glucose Monitoring System自测用血糖监测系统
Dec/30/2009No.519 in 2009For Technic Use (published version)Passive Implantable Medical Devices Products无源植入性医疗器械产品
Dec/24/2009No.514 in 2009For Technic Use (published version)Surgical Gauze Dressings (Class II) Products外科纱布敷料(第二类)产品
Jun/18/2009No.231 in 2009For Technic Use (published version)B-type Ultrasond Diagnostic Apparatus (Class II) ProductsB型超声诊断设备(第二类)产品
Mar/18/2009No.95 in 2009For Technic Use (published version)Gastric Tube Products胃管产品
Mar/18/2009No.95 in 2009For Technic Use (published version)One Time Usage Sterile Catheter Products一次性使用无菌导尿管产品
Mar/18/2009No.95 in 2009For Technic Use (published version)Endotracheal Intubation Products气管插管产品
Mar/18/2009No.95 in 2009For Technic Use (published version)Orthopedic External Fixation Products骨科外固定支架产品
Feb/20/2009No.95 in 2009For Technic Use (published version)Drug-containing Medical Devices Products含药医疗器械产品

 

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