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    CFDA Post-marketing Supervision-- Medical Device Quality Sampling (Nov-Jan, 2017)

    In order to strengthen medical devices quality supervision and ensure the product safety and effectiveness, CFDA keep conducting inspections within certain interval.

    CFDA Regulation Background

    • Regulations for the Supervision and Administration of Medical Devices

    • CFDA Announcement about Strengthening the Medical Device Sampling work

    • 'Medical Device Manual and Label Management Regulation'.

    The Statistic about Medical Device Quality Sampling  


    Medical device quality announcement issued time

    The amount of category for spot check

    Spot check sample size

    The disqualification amount of label and manual

    The disqualification percentage of label and manual (%)

    11/27/2017

    4

    44

    0

    0

    11/22/2017

    11

    54

    2

    3.70

    10/23/2017

    4

    110

    2

    1.82

    09/26/2017

    2

    44

    5

    11.36

    09/14/2017

    2

    55

    7

    12.73

    09/07/2017

    1

    145

    25

    17.24

    08/31/2017

    1

    48

    8

    16.67

    08/21/2017

    3

    155

    5

    3.23

    08/08/2017

    3

    202

    4

    1.98

    07/21/2017

    5

    150

    4

    2.67

    07/10/2017

    1

    94

    0

    0.00

    06/21/2017

    3

    247

    2

    0.81

    06/14/2017

    2

    206

    0

    0.00

    05/24/2017

    1

    41

    8

    19.51

    05/10/2017

    2

    147

    6

    4.08

    05/08/2017

    3

    59

    1

    1.69

    04/26/2017

    1

    58

    0

    0.00

    04/19/2017

    2

    54

    0

    0.00

    04/11/2017

    2

    78

    0

    0.00

    04/06/2017

    2

    128

    0

    0.00

    03/28/2017

    6

    79

    2

    2.53

    03/14/2017

    2

    1222

    0

    0.00

    02/23/2017

    4

    63

    2

    3.17

    02/15/2017

    6

    47

    2

    4.26

    01/20/2017

    5

    81

    1

    1.23


    医疗器械食品化妆品法规服务


    医疗器械食品化妆品法规服务


    Based on the statics, medical device label and manual compiling is still a challenge for the manufactures.


    If you have any questions about medical device label and manual compiling, please feel free to contact us at service@bbotek.cn  
    Label sample:

    医疗器械食品化妆品法规服务



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