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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:射頻消融設(shè)備用灌注泵	Class III	Class II
2	Light-emitting diode (LED) surgery lighting CN:發(fā)光二極管（LED）手術(shù)照明燈	Class II	Class I
3	The non-aseptic reusable surgical instruments for the intervertebral disc CN: 接觸椎間隙的非無(wú)菌提供的骨科重復(fù)使用手術(shù)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: 可能接觸中樞神經(jīng)系統(tǒng)的非無(wú)菌提供的骨科用鑿、銼、鏟、脊柱外科定位/導(dǎo)向/測(cè)量器械、脊柱外科開(kāi)孔擴(kuò)孔器械、脊柱外科神經(jīng)根探子、脊柱外科植骨塊嵌入器等	Class II	Class I
5	Open awl (Ex: hand awl) CN: 開(kāi)口用錐（如手錐）	Class II	Class I
6	Gastrointestinal imaging agent CN: 胃腸道造影顯像劑	Class III	Class II
7	Gastrointestinal ultrasound imaging powder CN: 胃腸超聲顯像粉	Class III	Class II
8	Radionuclide scanning device CN: 放射性核素掃描裝置	Class III	Class II
9	Endoscope airbag controller CN: 內(nèi)窺鏡氣囊控制器	Class III	Class II
10	Medical optical amplifier with LED light source CN: 帶有LED光源的醫(yī)用光學(xué)放大器具	Class II	Class I
11	Iodine protective cap CN: 碘液保護(hù)帽	Class III	Class II
12	Disposable biopsy needle CN: 一次性使用活檢針	Class III	Class II
13	Feet separation supplies, isolation shield CN: 足部隔離用品、隔離護(hù)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: 接觸胸腔、腹腔、腦室、腰椎、體內(nèi)創(chuàng)面或體表真皮深層及其以下組織創(chuàng)面的引流導(dǎo)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（含造口底盤(pán)）、造口護(hù)理用品、造口底盤(pán)、造口栓、防漏膏、造口護(hù)膚粉、造口皮膚保護(hù)劑等造口護(hù)理產(chǎn)品	Class II	Class I
16	The ilium puncture needle CN: 髂骨穿刺針	Class III	Class II
17	Nonchronic wound surface and skin dermis deep layer and below contacting unabsorbable body medical dressings CN: 用于非慢性創(chuàng)面、接觸真皮深層及其以下組織且所含成分不可被人體吸收的的醫(yī)用敷料	Class III	Class II
18	Desensitizing products CN: 脫敏劑類產(chǎn)品	Class III	Class II
19	Silver amalgam CN: 銀汞合金	Class III	Class II
20	Dental file, oral car needle, dental drill products and etc. cooperated ith active instruments (such as dental phones) CN: 與有源器械（如牙科手機(jī)）連接使用的牙科銼、口腔車(chē)針、牙科鉆（頭）等產(chǎn)品	Class II	Class I
21	Orthodontic spring CN: 正畸彈簧	Class II	Class I
22	Implant sealing material CN: 種植體密封材料	Class III	Class II
23	Periodontal pack CN: 牙周塞治劑	Class III	Class II
24	Dentifrice CN: 潔牙粉	Class III	Class II
25	Root canal enlarging liquid, root canal cleaning agent CN: 根管擴(kuò)大液、根管清洗劑	Class III	Class II
26	Temporary crown bridge resin CN: 臨時(shí)冠橋樹(shù)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射線影像處理系統(tǒng)、核醫(yī)學(xué)成像、醫(yī)用磁共振成像系統(tǒng)	Class III	Class II
29	Automatic enzyme-linked immunoanalyzer, automatic chemiluminescence immunoanalyzer, automatic fluorescence immunoanalyzer CN: 全自動(dòng)酶聯(lián)免疫分析儀、全自動(dòng)化學(xué)發(fā)光免疫分析儀、全自動(dòng)熒光免疫分析儀	Class III	Class II
30	Microbiological identification drug sensitive analysis instrument, microbial drug sensitive culture monitoring instrument CN: 微生物鑒定藥敏分析儀器、微生物藥敏培養(yǎng)監(jiān)測(cè)儀器	Class III	Class II
31	Microplate Washer CN: 洗板機(jī)	Class II	Class I

*If you have any comments or questions, please contact us at [email protected]

Related Links

New Medical Device Classification Catalog

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

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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