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:射頻消融設備用灌注泵	Class III	Class II
2	Light-emitting diode (LED) surgery lighting CN:發光二極管（LED）手術照明燈	Class II	Class I
3	The non-aseptic reusable surgical instruments for the intervertebral disc CN: 接觸椎間隙的非無菌提供的骨科重復使用手術器械	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: 可能接觸中樞神經系統的非無菌提供的骨科用鑿、銼、鏟、脊柱外科定位/導向/測量器械、脊柱外科開孔擴孔器械、脊柱外科神經根探子、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光源的醫用光學放大器具	Class II	Class I
11	Iodine protective cap CN: 碘液保護帽	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、體內創面或體表真皮深層及其以下組織創面的引流導管	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）、造口護理用品、造口底盤、造口栓、防漏膏、造口護膚粉、造口皮膚保護劑等造口護理產品	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用敷料	Class III	Class II
18	Desensitizing products CN: 脫敏劑類產品	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）連接使用的牙科銼、口腔車針、牙科鉆（頭）等產品	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: 根管擴大液、根管清洗劑	Class III	Class II
26	Temporary crown bridge resin CN: 臨時冠橋樹脂	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、核醫學成像、醫用磁共振成像系統	Class III	Class II
29	Automatic enzyme-linked immunoanalyzer, automatic chemiluminescence immunoanalyzer, automatic fluorescence immunoanalyzer CN: 全自動酶聯免疫分析儀、全自動化學發光免疫分析儀、全自動熒光免疫分析儀	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、微生物藥敏培養監測儀器	Class III	Class II
31	Microplate Washer CN: 洗板機	Class II	Class I

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

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Products Changed to be Lower Classification Catagories.

New Medical Device Classification Catalog

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