New Medical Device Classification Catalog--- Product Management Category Adjustment

September 4 2017, China Food and Drug Administration (CFDA) issued the announcement about the new version of ‘Medical Device Classification Catalog’.

In this new catalog, CFDA did some reasonable adjustment of product management category. According to the product risk level and the actual supervision, some medical device products that have long marketing time, high product maturity and controllable risk can change to be lower class of management categories.

Products Changed to be Lower Classification Catagories.

No.	Product	Original classification	New Classification
1	Infusion pumps for radiofrequency ablation devices CN:射频消融设备用灌注泵	Class III	Class II
2	Light-emitting diode (LED) surgery lighting CN:发光二极管（LED）手术照明灯	Class II	Class I
3	The non-aseptic reusable surgical instruments for the intervertebral disc CN: 接触椎间隙的非无菌提供的骨科重复使用手术器械	Class II	Class I
4	The central nervous system contactable non-aseptic for orthopedic chisel, file, shovel, spine position/guide/measuring instruments, spine open hole reaming devices, spine nerve root spies, spine bone graft of embedded device and etc. CN: 可能接触中枢神经系统的非无菌提供的骨科用凿、锉、铲、脊柱外科定位/导向/测量器械、脊柱外科开孔扩孔器械、脊柱外科神经根探子、脊柱外科植骨块嵌入器等	Class II	Class I
5	Open awl (Ex: hand awl) CN: 开口用锥（如手锥）	Class II	Class I
6	Gastrointestinal imaging agent CN: 胃肠道造影显像剂	Class III	Class II
7	Gastrointestinal ultrasound imaging powder CN: 胃肠超声显像粉	Class III	Class II
8	Radionuclide scanning device CN: 放射性核素扫描装置	Class III	Class II
9	Endoscope airbag controller CN: 内窥镜气囊控制器	Class III	Class II
10	Medical optical amplifier with LED light source CN: 带有LED光源的医用光学放大器具	Class II	Class I
11	Iodine protective cap CN: 碘液保护帽	Class III	Class II
12	Disposable biopsy needle CN: 一次性使用活检针	Class III	Class II
13	Feet separation supplies, isolation shield CN: 足部隔离用品、隔离护罩	Class II	Class I
14	The drainage catheter for thoracic cavity, abdominal cavity, ventricle, lumbar vertebra, wound in the body or skin dermis deep layer and below tissue wound contacting CN: 接触胸腔、腹腔、脑室、腰椎、体内创面或体表真皮深层及其以下组织创面的引流导管	Class III	Class II
15	Ostomy Bag( including Ostomy Chassis), Ostomy nursing materials, Ostomy Chassis, Stoma Suppository, Ostomy nursing powder, Ostomy skin protective agent and etc. CN: 造口袋（含造口底盘）、造口护理用品、造口底盘、造口栓、防漏膏、造口护肤粉、造口皮肤保护剂等造口护理产品	Class II	Class I
16	The ilium puncture needle CN: 髂骨穿刺针	Class III	Class II
17	Nonchronic wound surface and skin dermis deep layer and below contacting unabsorbable body medical dressings CN: 用于非慢性创面、接触真皮深层及其以下组织且所含成分不可被人体吸收的的医用敷料	Class III	Class II
18	Desensitizing products CN: 脱敏剂类产品	Class III	Class II
19	Silver amalgam CN: 银汞合金	Class III	Class II
20	Dental file, oral car needle, dental drill products and etc. cooperated ith active instruments (such as dental phones) CN: 与有源器械（如牙科手机）连接使用的牙科锉、口腔车针、牙科钻（头）等产品	Class II	Class I
21	Orthodontic spring CN: 正畸弹簧	Class II	Class I
22	Implant sealing material CN: 种植体密封材料	Class III	Class II
23	Periodontal pack CN: 牙周塞治剂	Class III	Class II
24	Dentifrice CN: 洁牙粉	Class III	Class II
25	Root canal enlarging liquid, root canal cleaning agent CN: 根管扩大液、根管清洗剂	Class III	Class II
26	Temporary crown bridge resin CN: 临时冠桥树脂	Class III	Class II
27	Plates terrier CN: 牙托梗	Class II	Class I
28	X-ray image processing system , Nuclear medical imaging , medical magnetic resonance imaging system CN: X射线影像处理系统、核医学成像、医用磁共振成像系统	Class III	Class II
29	Automatic enzyme-linked immunoanalyzer, automatic chemiluminescence immunoanalyzer, automatic fluorescence immunoanalyzer CN: 全自动酶联免疫分析仪、全自动化学发光免疫分析仪、全自动荧光免疫分析仪	Class III	Class II
30	Microbiological identification drug sensitive analysis instrument, microbial drug sensitive culture monitoring instrument CN: 微生物鉴定药敏分析仪器、微生物药敏培养监测仪器	Class III	Class II
31	Microplate Washer CN: 洗板机	Class II	Class I

*If you have any comments or questions, please contact us at md@cirs-group.com

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New Medical Device Classification Catalog--- Product Management Category Adjustment

Products Changed to be Lower Classification Catagories.

New Medical Device Classification Catalog

New Medical Device Classification Catalog --- The Expanded List of Non-medical Device