CFDA Medical Device Regulations Updated in 2017 - Regulatory News - Medical Devices

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

Supervision regulations and important documents
Guideline
Industry standards
Medical device manage quality supervision
Clinical trials
Recall
Innovated medical devices

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

（I）Supervision regulations and important documents

NO.	File name	Release date
	State council’s decision about modify ‘medical device supervision management regulations’ (CN: 李克強簽署國務院令公布《國務院關于修改<醫療器械監督管理條例>的決定》)	2017.05.19
	Medical device standard management method( CFDA 33th statute) (CN:《醫療器械標準管理辦法》（國家食品藥品監督管理總局令第33號）)	2017.04.26
	CFDA decision about adjusting partial medical device Administrative Approval, procedure(CFDA 32th statute) CN:《國家食品藥品監督管理總局關于調整部分醫療器械行政審批事項審批程序的決定》（國家食品藥品監督管理總局令第32號）	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 14^th statute) 食品藥品監督管理總局關于印發一次性使用塑料血袋等21種醫療器械生產環節風險清單和檢查要點的通知（食藥監械監〔2017〕14號）	2017.02.10
	In vitro diagnostic reagent (IVD) registration management method amendment (CFDA 30^th statute) 《體外診斷試劑注冊管理辦法修正案》（國家食品藥品監督管理總局令第30號）	2017.02.08
	CFDA announcement about medical device review communication management method (trial) (CFDA 19^th statute) 總局關于發布醫療器械審評溝通交流管理辦法（試行）的通告（2017年第19號）	2017.02.07

（II）Guideline

NO.	File name	Release date
	Exposure draft
	Announcement about endometrium remove devices clinical evaluation, technical investigate guideline(exposure draft) 關于公開征求子宮內膜去除設備臨床評價技術審查指導原則意見的通知	2017.06.30
	Announcement about helicobacter pylori antigen or antibody detection kit technical investigate guideline(exposure draft) 關于《幽門螺桿菌抗原/抗體檢測試劑技術審查指導原則》（征求意見稿）公開征求意見的通知	2017.06.29
	Announcement about one time use infusion pumps (Non-electrical) technical investigate guideline(exposure draft) 關于《一次性使用輸注泵（非電驅動）注冊技術審查原則》征求意見的通知	2017.06.20
	Announcement about blood and blood components storage bag registration technical investigate guideline-Non clinical evaluation part (exposure draft) 關于《血液及血液成分貯存袋注冊技術審查指導原則-非臨床評價部分》征求意見的通知	2017.06.20
	Announcement about hemoconcentrator registration technical investigate guideline (exposure draft) 關于《血液濃縮器注冊申報技術審查指導原則（征求意見稿）》征求意見的通知	2017.06.13
	Announcement about ophthalmic optical coherence tomography scanner registration technical investigate guideline (exposure draft) 關于公開征求眼科光學相干斷層掃描儀注冊技術審查指導原則意見的通知	2017.06.09
	Announcement about Automatic Blood Grouping Diagnostic Instrument registration technical investigate guideline (exposure draft) 關于《全自動血型分析儀注冊技術審查指導原則》（征求意見稿）公開征求意見的通知	2017.05.04
	Announcement about Anti human globulin detection reagent registration technical investigate guideline (exposure draft) 關于《抗人球蛋白檢測試劑技術審查指導原則》（征求意見稿）公開征求意見的通知	2017.05.04
	Announcement about ABO and RhD Blood type antigen test card (column agglutination) registration technical investigate guideline (exposure draft) 關于《ABO、RhD血型抗原檢測卡（柱凝集法）注冊技術審查指導原則》（征求意見稿）公開征求意見的通知	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) 關于《人表皮生長因子受體2基因擴增檢測試劑盒（熒光原位雜交法）技術審查指導原則》（征求意見稿）公開征求意見的通知	2017.04.18
	Released
	CFDA announcement about passive implanted medical devices storage rank validity registration application dossiers guideline (2017 revised edition)(2017, 75^th statute) 總局關于發布無源植入性醫療器械貨架有效期注冊申報資料指導原則（2017年修訂版）的通告（2017年第75號）	2017.05.26
	CFDA announcement about Ultrasonic Doppler foetal heartbeat detector and three other medical devices registration technical investigate guideline (2017, 60th statute) 總局關于發布超聲多普勒胎兒心率儀等4項注冊技術審查指導原則的通告（2017年第60號） 1. Ultrasonic Doppler foetal heartbeat detector registration technical investigate guideline 超聲多普勒胎兒心率儀注冊技術審查指導原則 2. Powered Traction Unit registration technical investigate guideline (2017 revised edition) 電動牽引裝置注冊技術審查指導原則（2017年修訂版） 3. Electric Surgical Unit registration technical investigate guideline (2017 revised edition) 電動手術臺注冊技術審查指導原則（2017年修訂版） 4. Diagnostics ultrasound system (class II)registration technical investigate guideline 影像型超聲診斷設備（第二類）注冊技術審查指導原則	2017.04.27
	CFDA announcement about Fetal chromosomal aneuploidy (T21, T18, T13) test kit registration technical investigate guideline(2017, 52th statute) 總局關于發布胎兒染色體非整倍體（T21、T18、T13）檢測試劑盒（高通量測序法）注冊技術審查指導原則的通告（2017年第52號）	2017.04.01
	CFDA announcement about Endoscopic Intraluminal Stapler and two other medical devices registration technical investigate guideline(2017, 44th statute) 總局關于發布腔鏡用吻合器等3項醫療器械產品注冊技術審查指導原則的通告（2017年第44號） 1.Endoscopic Intraluminal Stapler registration technical investigate guideline 腔鏡用吻合器產品注冊技術審查指導原則 2. Fiber post registration technical investigate guideline 牙科纖維樁產品注冊技術審查指導原則 3. Polyurethane Foam Dressing registration technical investigate guideline 聚氨酯泡沫敷料產品注冊技術審查指導原則	2017.03.22
	CFDA announcement about Syringe Pump and three other medical devices registration technical investigate guideline(2017, 41th statute) 總局關于發布注射泵等4項注冊技術審查指導原則的通告（2017年第41號） 1. Syringe Pump registration technical investigate guideline(2017 revised edition) 注射泵注冊技術審查指導原則（2017年修訂版） 2. Electrodes registration technical investigate guideline(2017 revised edition) 手術電極注冊技術審查指導原則（2017年修訂版） 3. Medical Digital Thermometer registration technical investigate guideline(2017 revised edition) 醫用電子體溫計注冊技術審查指導原則（2017年修訂版） 4. Diode Laser System (class II) registration technical investigate guideline(2017 revised edition) 半導體激光治療機（第二類）注冊技術審查指導原則（2017年修訂版）	2017.03.16
	CFDA announcement about visible spectrum therapeutic equipment and two other medical devices registration technical investigate guideline(2017, 40th statute) 總局關于發布可見光譜治療儀等3項注冊技術審查指導原則的通告（2017年第40號） 1. visible spectrum therapeutic equipment registration technical investigate guideline 可見光譜治療儀注冊技術審查指導原則 2. Fiberscope(class II) registration technical investigate guideline(2017 revised edition) 纖維內窺鏡（第二類）注冊技術指導原則（2017年修訂版） 3. Rigid endoscope(class II) registration technical investigate guideline(2017 revised edition) 硬管內窺鏡（第二類）注冊技術審查指導原則（2017年修訂版）	2017.03.16
	CFDA announcement about Cochlear Implant Systems registration technical investigate guideline(2017, 35th statute) 總局發布人工耳蝸植入系統技術審查指導原則的通告（2017年第35號）	2017.03.02
	CFDA announcement about Electrical Hospital Bed and two other medical devices registration technical investigate guideline(2017, 30th statute) 總局關于發布電動病床等3項注冊技術審查指導原則的通告（2017年第30號） 1. Electrical Hospital Bed registration technical investigate guideline(2017 revised edition) 電動病床注冊技術審查指導原則（2017年修訂版） 2. Laparoscope Instruments registration technical investigate guideline 腹腔鏡手術器械技術審查指導原則 3. Surgical Light registration technical investigate guideline 手術無影燈注冊技術審查指導原則	2017.02.28
	CFDA announcement about Mycobacterium tuberculosis composite group drug resistance gene mutation test registration technical investigate guideline(2017, 25th statute) 總局關于發布結核分枝桿菌復合群耐藥基因突變檢測試劑注冊技術審查指導原則的通告（2017年第25號）	2017.02.16
	CFDA announcement about cervical disc prosthesis and Hip Joint Prosthesis System registration technical investigate guideline(2017, 23th statute) 總局關于發布人工頸椎間盤假體和髖關節假體系統等2項注冊技術審查指導原則的通告（2017年第23號） 1. Cervical disc prosthesis registration technical investigate guideline 人工頸椎間盤假體注冊技術審查指導原則 2. Hip Joint Prosthesis System registration technical investigate guideline 髖關節假體系統注冊技術審查指導原則	2017.02.16
	CFDA announcement about calcium phosphate/ silicon Sealing Material and two other medical devices registration technical investigate guideline(2017, 14th statute) 總局關于發布鈣磷/硅類骨填充材料等3項注冊技術審查指導原則的通告（2017年第14號） 1. Calcium phosphate/ silicon Sealing Material registration technical investigate guideline 鈣磷/硅類骨填充材料注冊技術審查指導原則 2. Central Venous Catheterization Set registration technical investigate guideline 中心靜脈導管產品注冊技術審查指導原則 3. Medical Compression Stocking registration technical investigate guideline 襪型醫用壓力帶注冊技術審查指導原則	2017.02.10
	CFDA announcement about medical device network safety registration technical investigate guideline(2017, 13th statute) 總局關于發布醫療器械網絡安全注冊技術審查指導原則的通告（2017年第13號）	2017.01.24
	CFDA announcement about Magnetic Resonance System and three other medical devices registration technical investigate guideline(2017, 6th statute) 總局關于發布醫用磁共振成像系統臨床評價等4項醫療器械注冊技術審查指導原則的通告（2017年第6號） 1.Medical magnetic Resonance System registration technical investigate guideline 醫用磁共振成像系統臨床評價技術審查指導原則 2. Computed Tomography System registration technical investigate guideline 口腔頜面錐形束計算機體層攝影設備注冊技術審查指導原則 3. External Defibrillator registration technical investigate guideline 體外除顫產品注冊技術審查指導原則 4. Curing Light registration technical investigate guideline 光固化機注冊技術審查指導原則	2017.01.16
	CFDA announcement about Cochlear Implant Systems clinical trial guideline(2017, 3th statute) 總局關于發布人工耳蝸植入系統臨床試驗指導原則的通告（2017年第3號）	2017.01.06

（III）Industry standards

NO.	File name	Release date	Implementation date
1	CFDA solicit public opinions about abolishing YY 0097-1992 ‘Magnetotherapy cup’ and the other 25 medical devices industry standards. 總局辦公廳公開征求廢止YY 0097-1992《磁療保健杯》等26項醫療器械行業標準意見	2017.06.06
2	CFDA industry standards announcement about one time use centrifugal Plasmafilter and other 27 medical devices (2017, 49th statute) 總局關于批準發布《一次性使用離心式血漿分離器》等28項醫療器械行業標準的公告（2017年第49號）	2017.05.05	2018.04.01
3	CFDA 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 38^th statues) 總局關于批準發布《口腔醫療器械生物學評價第7部分：牙髓牙本質應用試驗》等40項醫療器械行業標準的公告（2017年第38號）	2017.04.01	2018.04.01
4	CFDA industry standards announcement about contacting wound dressing test method part 5: bacterial resistance and the other 9 medical devices(2017, the 25^th statues 總局關于批準發布《接觸性創面敷料試驗方法第5部分：阻菌性》等10項醫療器械行業標準的公告（2017年第25號）	2017.03.03	2018.01.01
5	CFDA approved and issued YY/T 0287-2107 'medical device quality management system ,the requirements for the regulation'(2017, the 11^th) 總局關于批準發布YY/T 0287-2107《醫療器械質量管理體系用于法規的要求》（2017第11號）	2017.02.04	2017.05.01

（IV）Medical device manage quality supervision

NO.	File name	Release date
1	CFDA solicit public opinions about 'Online medical device manage supervision management methods' 總局關于公開征求《網絡醫療器械經營監督管理辦法（征求意見稿）》意見的通知	2017.06.21
2	CFDA solicit public opinions about 'Online medical device manage illegal behavior investigation methods'（2017, the 30^th）關于征求《網絡醫療器械經營違法行為查處辦法（征求意見稿）》意見的函食藥監械監便函〔2017〕30號	2017.03.29

（V）Clinical trials

NO.	File name	Release date
1	CFDA 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 14^th ) 關于征求《免于進行臨床試驗的第二類體外診斷試劑目錄（第二批）》和《免于進行臨床試驗的體外診斷試劑臨床評價資料基本要求》意見的函食藥監械管便函〔2017〕14號	2017.05.24
2	CFDA solicit public opinions about third batch clinical trial exempted medical devices catalog 關于征求第三批免于進行臨床試驗醫療器械目錄意見的函	2017.05.17

（VI）Recall

NO.	File name	Release date	Implementation date
1	Medical device recall management method (CFDA, the 29^th statues) 《醫療器械召回管理辦法》（國家食品藥品監督管理總局令第29號）	2017.02.08	2017.05.05

（VII）Innovated medical devices

NO.	File name	Release date
1	CFDA solicit public opinions about ‘About Encouraging Medicines and Medical Devices Revolution, the protection regulation for the innovators’(exposure draft)( 2017, 55^th) 總局關于征求《關于鼓勵藥品醫療器械創新保護創新者權益的相關政策（征求意見稿）》意見的公告（2017年第55號）	2017.05.12
2	CFDA 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 52^nd ) 總局關于征求《關于鼓勵藥品醫療器械創新加快新藥醫療器械上市審評審批的相關政策》（征求意見稿）意見的公告（2017年第52號）	2017.05.11
3	CFDA 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 54^th ) 總局關于征求《關于鼓勵藥品醫療器械創新實施藥品醫療器械全生命周期管理的相關政策》（征求意見稿）意見的公告（2017年第54號）	2017.05.11
4	CFDA solicit public opinions about ‘Encourage Medicines and Medical Devices Revolution Innovate Clinical Test Management System Regulations (first draft)’(2017, the 53^rd ) 總局關于征求《關于鼓勵藥品醫療器械創新改革臨床試驗管理的相關政策》（征求意見稿）意見的公告（2017年第53號）	2017.05.11
5	CFDA announcement about medical device prior approval application dossiers preparation guideline (trial version) (2017, the 28^th ) 食品藥品總局關于發布醫療器械優先審批申報資料編寫指南（試行）的通告（2017年第28號）	2017.02.16

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