2020年康復(fù)醫(yī)療器械行業(yè)分析報告

2020年康復(fù)醫(yī)療器械

行業(yè)分析報告

2020年1月

目錄

一、行業(yè)主管部門、監(jiān)管體制及法律法規(guī).........................................5

1、行業(yè)主管部門及職能........................................................................................5

2、行業(yè)自律組織....................................................................................................5

3、行業(yè)監(jiān)管體制....................................................................................................6

（1）醫(yī)療器械產(chǎn)品的分類管理.........................................................................................6

（2）醫(yī)療器械產(chǎn)品注冊與備案制度.................................................................................7

（3）醫(yī)療器械生產(chǎn)制造企業(yè)備案與許可證制度.............................................................7

（4）醫(yī)療器械經(jīng)營企業(yè)備案與許可證管理制度.............................................................8

4、行業(yè)主要法律法規(guī)............................................................................................8

5、行業(yè)主要發(fā)展規(guī)劃及政策................................................................................9

二、行業(yè)市場狀況............................................................................11

1、康復(fù)醫(yī)療器械行業(yè)..........................................................................................11

2、電刺激類康復(fù)醫(yī)療器械行業(yè)..........................................................................13

（1）電刺激康復(fù)器械的臨床應(yīng)用...................................................................................13

①盆底及產(chǎn)后康復(fù).......................................................................................................13

②神經(jīng)康復(fù)...................................................................................................................14

（2）電刺激康復(fù)器械的市場...........................................................................................15

3、磁刺激類康復(fù)醫(yī)療器械行業(yè)..........................................................................17

（1）磁刺激康復(fù)器械的臨床應(yīng)用...................................................................................17

①經(jīng)顱磁刺激儀...........................................................................................................17

②盆底功能磁刺激儀...................................................................................................19

（3）磁刺激類康復(fù)醫(yī)療器械的市場...............................................................................20

4、電生理類康復(fù)醫(yī)療器械行業(yè)..........................................................................21

（1）電生理類康復(fù)器械的臨床應(yīng)用...............................................................................22

①表面肌電分析...........................................................................................................22

②生物反饋儀...............................................................................................................22

③新生兒腦電測量儀...................................................................................................22

（2）電生理類康復(fù)器械市場...........................................................................................23

5、康復(fù)機(jī)器人行業(yè)..............................................................................................24

（1）康復(fù)機(jī)器人的臨床應(yīng)用...........................................................................................24

（2）康復(fù)機(jī)器人市場.......................................................................................................25

三、行業(yè)發(fā)展態(tài)勢、面臨的機(jī)遇和挑戰(zhàn)..........................................26

1、行業(yè)發(fā)展態(tài)勢..................................................................................................26

（1）傳統(tǒng)康復(fù)治療技術(shù)不斷升級...................................................................................26

（2）新型康復(fù)治療技術(shù)逐步被研發(fā)并商業(yè)化應(yīng)用.......................................................27

（3）市場需求向二級醫(yī)院、基層醫(yī)院、民營醫(yī)院、社區(qū)家庭等領(lǐng)域下沉...............28

（4）康復(fù)覆蓋的疾病不斷豐富.......................................................................................28

2、面臨的機(jī)遇......................................................................................................29

（1）有利政策的推動.......................................................................................................29

（2）醫(yī)保覆蓋范圍的擴(kuò)大、居民支付能力和意愿的增強(qiáng)...........................................30

（3）康復(fù)醫(yī)療需求的增加...............................................................................................31

3、面臨的挑戰(zhàn)......................................................................................................32

（1）融資環(huán)境仍不成熟...................................................................................................32

（2）專業(yè)人才匱乏...........................................................................................................32

四、行業(yè)主要企業(yè)情況.....................................................................32

1、河南翔宇醫(yī)療設(shè)備股份有限公司..................................................................32

2、常州市錢璟康復(fù)股份有限公司......................................................................33

3、深圳市普門科技股份有限公司......................................................................33

4、廣州市杉山醫(yī)療器械實業(yè)有限公司..............................................................33

5、南京麥瀾德醫(yī)療科技有限公司......................................................................33

6、廣州龍之杰科技有限公司..............................................................................33

7、武漢依瑞德醫(yī)療設(shè)備新技術(shù)有限公司..........................................................34

8、TheMagstimCompanyLtd...............................................................................34

9、Neuronetics,Inc................................................................................................34

10、BrainswayLtd..................................................................................................34

11、ReWalkRoboticsLtd.......................................................................................35

12、Hocoma...........................................................................................................35

13、北京大艾機(jī)器人科技有限公司....................................................................3