Weekly CFDA News Roundup covers government reports, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
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Government Report
CFDA published Medical Device Registration Report for 2017. In the year of 2017, 2,823 imported class II and 2,800 imported class III medical devices and IVDs registered. The top five imported medical devices registered are: implantable materials and artificial organs, optical and endoscopic equipment, dental materials, medical polymer materials, and major electronic equipment. The top five countries exporting medical devices and IVDs to China are: US (1,469), Germany (827), Japan (404), UK (237) and Korea (195).
Guideline
CFDA issued technical review guideline on rigid optical endoscope.
QA/Recall/AE
- CFDA announced recall notices from two manufacturers:
- GE: infant incubator
- Philips: computed tomography x-ray system
- CFDA published adverse event notification for hyaluronic acid, an injection for plastic surgery.
New Approval
CFDA granted innovation approval to RT-PCR detection assay for colorectal cancer, by GeneBio Health, an IVD manufacturer based in Shenzhen.
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China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. We have an office in Beijing, Suzhou and Boston. www.ChinaMedDevice.com
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------