Information boards

20201102173908

Medical Device Announcement :

●Announcement of the State Food and Drug Administration on the approval and Registration of172 medical devices (No.53 in 2020) (April 15, 2020)

●Notice on guidelines for medical device registrants to carry out adverse event monitoring fromState Food and Drug Administration . (No. 25 2020)( April 10,2020 )

●Announcement of the State Food and Drug Administration on the issuance of 12 medical deviceindustry standards and one amendment(No.48 in 2020) including yy-0336-2020

' disposable sterile vaginal dilator . ( 9 th April 2020 ) .

●Notice of the Health Commission of State Food and Drug Administration on the issuance ofthe provisions on the Management of extended clinical trials of medical devices .

(Trial)(No.41 in 2020)(20th March 2020 )

●Announcement of the State Food and Drug Administration on the issuance of 24 medical deviceindustry standards and 6 amendments (No.20,2020)(2020-03-06)including yy-0833-2020

general technical requirements for limb compression physiotherapy equipment .

●Announcement of the State Food and Drug Administration of the people 's Republic of Chinaon the issuance of 7 guiding principles for the review of registration technology ,includingcolloidal gold immunochromatography (No.14 in 2020)(March 5th 2020 ) .

●Announcement of the State Food and Drug Administration on the release of 7 medicalDevice industry standards and 1 amendment (No.21, 2020)(March 2th 2020 )

Including yy-0167-2020 non absorbable surgical suture .

●Notice of the State Food and Drug Administration on the real problems in the supervisionAnd spot check of clinical trials of medical devices in 2019 (No.22 in 2020) ,( 2020-02-28 )

Announcement of the State Food and Drug Administration on approval and registrationof 120 medical device products (January 2020)(No.16 in 2020), (2020-02-27)

●Notice of State Food and Drug Administration on cancellation of medical device certificate( No.4 in 2020) ( 2020-02-19 ) .

●Notice of State Food and Drug Administration on approval and registration of 220 medicaldevices (December 2019)(No.13 in 2020 ) (2020-02-19)

●Announcement of State Food and Drug Administration on approval and registration of 201Medical devices ( November 2019 ) (No. 5 in 2020)(2020-01-09)

●Notice of the State Food and Drug Administration on the suspension and rectificationof zhe jiang Taisite Biotechnology Co., Ltd.(No.2 in 2020 ) (2020-01-08)

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●Notice of the State Food and Drug Administration on the suspension and rectification ofGuangxi double key technology Co., Ltd.(No.104 in 2019) ( December 31 , 2019 )

●Notice of the State Food and Drug Administration on Issuing the guiding principles

for the naming of common names of medical devices(No. 99 in 2019)(December 25, 2019)

●Notice of State Food and Drug Administration on cancellation of medical devicecertificate (No.93 in 2019) ( December 24,2019 )

●Notice of the State Food and Drug Administration on canceling the registration certificate ofDisposable anesthesia puncture kits (No.105,2019)(December 23,2019)

●Announcement of the State Food and Drug Administration on the conversion of 40 compulsorymedical device industry standards into recommended industry standards,compulsory medical

device industry standards is about the medical diagnostic X-ray radiation protective devicesPart 1: Determination of material attenuation performance and so on .

●State Food and Drug Administration of the people's Republic of China on medical diagnosticX-ray protective equipment Part 1 : Determination of material attenuation performance.

Announcement of 40 mandatory medical device industry standards into recommended industrystandards . ( No.106 at the end of 2019 ).

 


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