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

In order to strengthen medical devices quality supervision and management 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

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 (%)
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 statistcs, CFDA keep strengthening their supervision on the medical device. And 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 CIRS at md@cirs-group.com.

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