NMPA Announces Cancellation of Registration Certificates for Pelvic Floor Repair System and Three Other Medical Devices

On June 14, the National Medical Products Administration issued the “Notice of the National Medical Products Administration on Canceling the Registration of 4 Products Including the Pelvic Floor Repair System”Medical DevicesAnnouncement on Registration Certificates (No. 49 of 2019).

The announcement stated that, in accordance with the provisions of the Measures for the Administration of Medical Device Registration and upon enterprise applications, the medical device registration certificates for the following four products from four enterprises, including Boston Scientific Corporation, are hereby cancelled:

1. One product of Boston Scientific Corporation: Pelvic Floor Repair System, Registration Certificate No.: Guo Xie Zhu Jin 20163461183.

II. One product from C.R. Bard, Inc.: Bio-Pelvic Floor Repair System, Registration Certificate No.: Guo Xie Zhu Jin 20153462255.

3. One product from Autobio Experimental Instruments (Zhengzhou) Co., Ltd.: Fully Automatic Chemiluminescence Immunoassay Analyzer, Registration Certificate No.: Guo Xie Zhu Zhun 20153400681.

IV. One product of Konica Minolta, Inc. (Konica Minolta, Inc., コニカミノルタ株式会社): Pulse Oximeter, Registration Certificate No.: Guo Xie Zhu Jin 20142215488.

Previously (on April 4, 2018), the National Medical Products Administration issued an announcement titled “Boston Scientific Corporation’s Voluntary Recall of Pelvic Floor Repair Systems and Single-Incision Sling Systems,” which stated thatBoston Scientific International Medical Trading (Shanghai) Co., Ltd. reported that, due to the Australian Therapeutic Goods Administration’s decision on January 4, 2018, to cancel the registration of pelvic floor repair systems and single-incision sling systems in Australia, the manufacturer, Boston Scientific Corporation, initiated a voluntary recall of its pelvic floor repair systems (Registration Certificate No.: Guo Xie Zhu Jin 20163461183) and single-incision sling systems (Registration Certificate No.: 20163461461). The recall is classified as Class II.

Source: National Medical Products Administration