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CFDA Medical Device Regulations Updated in 2017

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In the first half year of 2017, CFDA already issued so many medical device related regulations, notifications, guideline, industrial standards and etc. that the medical devices supervision and management is becoming more standardize in China.

CIRS summarized seven main catagories

Here are the detailed medical device regulations, notifications, guideline, industrial standards and etc updated in 2017

ISupervision regulations and important documents

NO.File nameRelease date
State council’s decision about modify ‘medical device supervision management regulations’
(CN: 李克强签署国务院令 公布《国务院关于修改<医疗器械监督管理条例>的决定》)
2017.05.19
Medical device standard management method( CFDA 33th statute)
(CN:《医疗器械标准管理办法》(国家食品药品监督管理总局令第33号))
2017.04.26
CFDA decision about adjusting partial medical device Administrative Approval, procedure(CFDA 32th statute)
CN:《国家食品药品监督管理总局关于调整部分医疗器械行政审批事项审批程序的决定》(国家食品药品监督管理总局令第32号)
2017.04.06
CFDA announcement about one time use plastic blood bag and other 21 kinds of medical device manufacturing risk list and inspection point (CFDA 2017 14th statute)
食品药品监督管理总局关于印发一次性使用塑料血袋等21种医疗器械生产环节风险清单和检查要点的通知(食药监械监〔2017〕14号)
2017.02.10
In vitro diagnostic reagent (IVD) registration management method amendment (CFDA 30th statute)
《体外诊断试剂注册管理办法修正案》(国家食品药品监督管理总局令第30号)
2017.02.08
CFDA announcement about medical device
review communication management method (trial) (CFDA 19th statute)
总局关于发布医疗器械审评沟通交流管理办法(试行)的通告(2017年第19号)
2017.02.07


IIGuideline

NO.File nameRelease date
Exposure draft
Announcement about endometrium remove devices clinical evaluation, technical investigate guideline(exposure draft)
关于公开征求子宫内膜去除设备临床评价技术审查指导原则意见的通知
2017.06.30
Announcement about helicobacter pylori antigen or antibody detection kit technical investigate guideline(exposure draft)
关于《幽门螺杆菌抗原/抗体检测试剂技术审查指导原则》(征求意见稿)公开征求意见的通知
2017.06.29
Announcement about one time use infusion pumps (Non-electrical) technical investigate guideline(exposure draft)
关于《一次性使用输注泵(非电驱动)注册技术审查原则》征求意见的通知
2017.06.20
Announcement about blood and blood components storage bag registration technical investigate guideline-Non clinical evaluation part (exposure draft)
关于《血液及血液成分贮存袋注册技术审查指导原则-非临床评价部分》征求意见的通知
2017.06.20
Announcement about hemoconcentrator registration technical investigate guideline (exposure draft)
关于《血液浓缩器注册申报技术审查指导原则(征求意见稿)》征求意见的通知
2017.06.13
Announcement about ophthalmic optical coherence tomography scanner registration technical investigate guideline (exposure draft)
关于公开征求眼科光学相干断层扫描仪注册技术审查指导原则意见的通知
2017.06.09
Announcement about Automatic Blood Grouping Diagnostic Instrument registration technical investigate guideline (exposure draft)
关于《全自动血型分析仪注册技术审查指导原则》(征求意见稿)公开征求意见的通知
2017.05.04
Announcement about Anti human globulin detection reagent registration technical investigate guideline (exposure draft)
关于《抗人球蛋白检测试剂技术审查指导原则》(征求意见稿)公开征求意见的通知
2017.05.04
Announcement about ABO and RhD Blood type antigen test card (column agglutination) registration technical investigate guideline (exposure draft)
关于《ABO、RhD血型抗原检测卡(柱凝集法)注册技术审查指导原则》(征求意见稿)公开征求意见的通知
2017.05.04
Announcement about human epidermal growth factor receptor 2 gene amplification detection kit (fluorescence in situ hybridization) registration technical investigate guideline (exposure draft)
关于《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)技术审查指导原则》(征求意见稿)公开征求意见的通知
2017.04.18
Released
CFDA announcement about passive implanted medical devices storage rank validity registration application dossiers guideline (2017 revised edition)(2017, 75th statute)
总局关于发布无源植入性医疗器械货架有效期注册申报资料指导原则(2017年修订版)的通告(2017年第75号)
2017.05.26
CFDA announcement about Ultrasonic Doppler foetal heartbeat detector and three other medical devices registration technical investigate guideline (2017, 60th statute)
总局关于发布超声多普勒胎儿心率仪等4项注册技术审查指导原则的通告(2017年第60号)
1. Ultrasonic Doppler foetal heartbeat detector registration technical investigate guideline
超声多普勒胎儿心率仪注册技术审查指导原则
2. Powered Traction Unit registration technical investigate guideline (2017 revised edition)
电动牵引装置注册技术审查指导原则(2017年修订版)
3. Electric Surgical Unit registration technical investigate guideline (2017 revised edition)
电动手术台注册技术审查指导原则(2017年修订版)
4. Diagnostics ultrasound system (class II)registration technical investigate guideline
影像型超声诊断设备(第二类)注册技术审查指导原则
2017.04.27
CFDA announcement about Fetal chromosomal aneuploidy (T21, T18, T13) test kit registration technical investigate guideline(2017, 52th statute)
总局关于发布胎儿染色体非整倍体(T21、T18、T13)检测试剂盒(高通量测序法)注册技术审查指导原则的通告(2017年第52号)
2017.04.01
CFDA announcement about Endoscopic Intraluminal Stapler and two other medical devices registration technical investigate guideline(2017, 44th statute)
总局关于发布腔镜用吻合器等3项医疗器械产品注册技术审查指导原则的通告(2017年第44号)
1.Endoscopic Intraluminal Stapler registration technical investigate guideline
腔镜用吻合器产品注册技术审查指导原则
2. Fiber post registration technical investigate guideline
牙科纤维桩产品注册技术审查指导原则
3. Polyurethane Foam Dressing registration technical investigate guideline
聚氨酯泡沫敷料产品注册技术审查指导原则
2017.03.22
CFDA announcement about Syringe Pump and three other medical devices registration technical investigate guideline(2017, 41th statute)
总局关于发布注射泵等4项注册技术审查指导原则的通告(2017年 第41号)
1. Syringe Pump registration technical investigate guideline(2017 revised edition)
注射泵注册技术审查指导原则(2017年修订版)
2. Electrodes registration technical investigate guideline(2017 revised edition)
手术电极注册技术审查指导原则(2017年修订版)
3. Medical Digital Thermometer registration technical investigate guideline(2017 revised edition)
医用电子体温计注册技术审查指导原则(2017年修订版)
4. Diode Laser System (class II) registration technical investigate guideline(2017 revised edition)
半导体激光治疗机(第二类)注册技术审查指导原则(2017年修订版)
2017.03.16
CFDA announcement about visible spectrum therapeutic equipment and two other medical devices registration technical investigate guideline(2017, 40th statute)
总局关于发布可见光谱治疗仪等3项注册技术审查指导原则的通告(2017年 第40号)
1. visible spectrum therapeutic equipment registration technical investigate guideline
可见光谱治疗仪注册技术审查指导原则
2. Fiberscope(class II) registration technical investigate guideline(2017 revised edition)
纤维内窥镜(第二类)注册技术指导原则(2017年修订版)
3. Rigid endoscope(class II) registration technical investigate guideline(2017 revised edition)
硬管内窥镜(第二类)注册技术审查指导原则(2017年修订版)
2017.03.16
CFDA announcement about Cochlear Implant Systems registration technical investigate guideline(2017, 35th statute)
总局发布人工耳蜗植入系统技术审查指导原则的通告(2017年第35号)
2017.03.02
CFDA announcement about Electrical Hospital Bed and two other medical devices registration technical investigate guideline(2017, 30th statute)
总局关于发布电动病床等3项注册技术审查指导原则的通告(2017年第30号)
1. Electrical Hospital Bed registration technical investigate guideline(2017 revised edition)
电动病床注册技术审查指导原则(2017年修订版)
2. Laparoscope Instruments registration technical investigate guideline
腹腔镜手术器械技术审查指导原则
3. Surgical Light registration technical investigate guideline
手术无影灯注册技术审查指导原则
2017.02.28
CFDA announcement about Mycobacterium tuberculosis composite group drug resistance gene mutation test registration technical investigate guideline(2017, 25th statute)
总局关于发布结核分枝杆菌复合群耐药基因突变检测试剂注册技术审查指导原则的通告(2017年第25号)
2017.02.16
CFDA announcement about cervical disc prosthesis and Hip Joint Prosthesis System registration technical investigate guideline(2017, 23th statute)
总局关于发布人工颈椎间盘假体和髋关节假体系统等2项注册技术审查指导原则的通告(2017年第23号)
1. Cervical disc prosthesis registration technical investigate guideline
人工颈椎间盘假体注册技术审查指导原则
2. Hip Joint Prosthesis System registration technical investigate guideline
髋关节假体系统注册技术审查指导原则
2017.02.16
CFDA announcement about calcium phosphate/ silicon Sealing Material and two other medical devices registration technical investigate guideline(2017, 14th statute)
总局关于发布钙磷/硅类骨填充材料等3项注册技术审查指导原则的通告(2017年第14号)
1. Calcium phosphate/ silicon Sealing Material registration technical investigate guideline
钙磷/硅类骨填充材料注册技术审查指导原则
2. Central Venous Catheterization Set registration technical investigate guideline
中心静脉导管产品注册技术审查指导原则
3. Medical Compression Stocking registration technical investigate guideline
袜型医用压力带注册技术审查指导原则
2017.02.10
CFDA announcement about medical device network safety registration technical investigate guideline(2017, 13th statute)
总局关于发布医疗器械网络安全注册技术审查指导原则的通告(2017年第13号)
2017.01.24
CFDA announcement about Magnetic Resonance System and three other medical devices registration technical investigate guideline(2017, 6th statute)
总局关于发布医用磁共振成像系统临床评价等4项医疗器械注册技术审查指导原则的通告(2017年第6号)
1.Medical magnetic Resonance System registration technical investigate guideline
医用磁共振成像系统临床评价技术审查指导原则
2. Computed Tomography System registration technical investigate guideline
口腔颌面锥形束计算机体层摄影设备注册技术审查指导原则
3. External Defibrillator registration technical investigate guideline
体外除颤产品注册技术审查指导原则
4. Curing Light registration technical investigate guideline
光固化机注册技术审查指导原则
2017.01.16
CFDA announcement about Cochlear Implant Systems clinical trial guideline(2017, 3th statute)
总局关于发布人工耳蜗植入系统临床试验指导原则的通告(2017年第3号)
2017.01.06


IIIIndustry standards

NO.File nameRelease dateImplementation date
1CFDA solicit public opinions about abolishing YY 0097-1992 ‘Magnetotherapy cup’ and the other 25 medical devices industry standards.
总局办公厅公开征求废止YY 0097-1992《磁疗保健杯》等26项医疗器械行业标准意见
2017.06.06
2CFDA industry standards announcement about one time use centrifugal Plasmafilter and other 27 medical devices (2017, 49th statute)
总局关于批准发布《一次性使用离心式血浆分离器》等28项医疗器械行业标准的公告(2017年第49号)
2017.05.052018.04.01
3CFDA announcement about ‘oral cavity medical devices biological assessment the part 7: endodontium dentin test’ industry standards and other 39 medical devices industry standards (2017, the 38th statues)
总局关于批准发布《口腔医疗器械生物学评价 第7部分:牙髓牙本质应用试验》等40项医疗器械行业标准的公告(2017年第38号)
2017.04.012018.04.01
4CFDA industry standards announcement about contacting wound dressing test method part 5: bacterial resistance and the other 9 medical devices(2017, the 25th statues
总局关于批准发布《接触性创面敷料试验方法第5部分:阻菌性》等10项医疗器械行业标准的公告(2017年第25号)
2017.03.032018.01.01
5CFDA approved and issued YY/T 0287-2107 'medical device quality management system ,the requirements for the regulation'(2017, the 11th)
总局关于批准发布YY/T 0287-2107《医疗器械 质量管理体系 用于法规的要求》(2017第11号)
2017.02.042017.05.01

IVMedical device manage quality supervision

NO.File nameRelease date
1CFDA solicit public opinions about 'Online medical device manage supervision management methods'
总局关于公开征求《网络医疗器械经营监督管理办法(征求意见稿)》意见的通知
2017.06.21
2CFDA solicit public opinions about 'Online medical device manage illegal behavior investigation methods'(2017, the 30th
关于征求《网络医疗器械经营违法行为查处办法(征求意见稿)》意见的函 食药监械监便函〔2017〕30号
2017.03.29

VClinical trials

NO.File nameRelease date
1CFDA solicit public opinions about 'Class II in vitro diagnostic reagent clinical trial exemption catalog(second batch) 'and 'Clinical trial exempted in vitro diagnostic reagent clinical evaluation document basic requirements'(2017, the 14th )
关于征求《免于进行临床试验的第二类体外诊断试剂目录(第二批)》和《免于进行临床试验的体外诊断试剂临床评价资料基本要求》意见的函食药监械管便函〔2017〕14号
2017.05.24
2CFDA solicit public opinions about third batch clinical trial exempted medical devices catalog
关于征求第三批免于进行临床试验医疗器械目录意见的函
2017.05.17

VIRecall

NO.File nameRelease dateImplementation date
1Medical device recall management method (CFDA, the 29th statues)
《医疗器械召回管理办法》(国家食品药品监督管理总局令第29号)
2017.02.082017.05.05

VIIInnovated medical devices

NO.File nameRelease date
1CFDA solicit public opinions about ‘About Encouraging Medicines and Medical Devices Revolution, the protection regulation for the innovators’(exposure draft)( 2017, 55th)
总局关于征求《关于鼓励药品医疗器械创新保护创新者权益的相关政策(征求意见稿)》意见的公告(2017年第55号)
2017.05.12
2CFDA solicit public opinions about ‘About Encouraging Medicines and Medical Devices Revolution, Speed Up the Selling Audit Process of New Medical and Medical Devices Regulations (exposure draft)’(2017, the 52nd )
总局关于征求《关于鼓励药品医疗器械创新加快新药医疗器械上市审评审批的相关政策》(征求意见稿)意见的公告(2017年第52号)
2017.05.11
3CFDA solicit public opinions about ‘About Encourage Medicines and Medical Devices Revolution, Establish the New Medical and Medical Devices Full Life Circle Management Regulations (first draft)’(2017,the 54th )
总局关于征求《关于鼓励药品医疗器械创新实施药品医疗器械全生命周期管理的相关政策》(征求意见稿)意见的公告(2017年第54号)
2017.05.11
4CFDA solicit public opinions about ‘Encourage Medicines and Medical Devices Revolution Innovate Clinical Test Management System Regulations (first draft)’(2017, the 53rd )
总局关于征求《关于鼓励药品医疗器械创新改革临床试验管理的相关政策》(征求意见稿)意见的公告(2017年第53号)
2017.05.11
5CFDA announcement about medical device prior approval application dossiers preparation guideline (trial version) (2017, the 28th )
食品药品总局关于发布医疗器械优先审批申报资料编写指南(试行)的通告(2017年第28号)
2017.02.16

  

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