Medical network - February 13
Provinces, autonomous regions and municipalities directly under the food and drug administration, the xinjiang production and construction corps food and drug administration:
In order to enhance the risk identification ability of medical device supervision personnel, enhance the level of medical equipment production and regulatory risk prevention and control, according to the regulations on the supervision and administration of medical devices (state council order no. 650), "medical devices supervision and administration of production method" (the state food and drug supervision and administration of administration makes no. 7), "medical equipment production and the quality control standard" (the state food and drug administration bureau announcement no. 64, 2014) and its supporting documents, the food and drug supervision bureau to make the disposable plastic bags of 21 kinds of medical equipment production risk list and check the key point of (hereinafter referred to as "risk list and check point"), are hereby printed and distributed.
The risk list and check points mainly for the food and drug supervision and administration departments at various levels supervision personnel responsible for the supervision and inspection of relevant medical device manufacturing enterprise, with "medical equipment production and the quality control standard for relevant on-site inspection guidelines used as a guide, you may refer to other types of inspection is used.
Attachment: disposable plastic bags of 21 kinds of medical equipment production risk list and check points
The food and drug supervision bureau
On February 3, 2017 |
