On April 19th, the CFDA released the 8th issue of the 2017 Medical Device Quality Announcement (Total Issue 26). The State Food and Drug Administration has organized quality supervision and sampling on products of 54 varieties of breast implants and surgical singles. The results show that the medical equipment products that are not in compliance with the standard are related to the medical equipment manufacturers. The two varieties of 6 batches; the sampling items all meet the standard requirements of the medical device products involving 39 medical device manufacturers of two varieties of 48 batches.
Six of the products that do not meet the standard requirements include:
1. Sampling unit: Shanghai Weining Plastic Products Co., Ltd.
Label product name: silicone gel breast implant
Marking production enterprise: Shanghai Weining Plastic Products Co., Ltd.
Specification model: M220 h
Production date / batch number / factory number
Unqualified items: D4, D5 residues in the gel
2. The unit being sampled: the Fourth Affiliated Hospital of Harbin Medical University
Label product name: single use sterile pad
Marking production enterprise: Harbin Angel Health Material Factory
Specification model: 145×90
Production date / batch number / factory number: production date: November 13, 2015; batch number
Unqualified item: sterile
3. The unit being sampled: Pu'er Wanhe Hospital
Label product name: single use surgical order
Marking production enterprise: Nanchang Weicai Medical Devices Co., Ltd.
Specification model: A type pad single 120×80
Production date / batch number / factory number: September 08, 2015
Unqualified item: sterile
4, the spot check unit: the sixth hospital of Chengde City
Label product name: single use surgical pad
Marking production enterprise: Nanchang Xiangyu Medical Equipment Co., Ltd.
Specifications Model: Model: Type B pad; Specification: 220cm × 90cm
Production date / batch number / factory number: April 5, 2016
Unqualified items: 1. Tensile strength, dry state (non-critical areas of the product); 2. Sterile
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