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

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.

CIRS Medical Device Manual and Label Compiling Service
If you have any questions about medical device label and manual compiling, please feel free to contact CIRS at md@cirs-group.com.
Label sample:

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