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 |
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:
