Weekly CFDA News Roundup covers policies, 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.
Policy
CFDA issued Interpretation of Clinical Trials Quality Control for Medical Devices. It requires that, to ensure consistency of clinical trial protocols in two-site clinical trials, a lead entity shall be defined, and the clinical trial shall be conducted in the same period of time.
Guideline
CFDA issued 4 technical review guidelines, covering urology, gynecology and general devices.
- Urology: technical review guideline on Insufflator
- General: technical review guideline on medical cooler
- Urology: technical review guideline on electrical urinometer
- Gynecology: technical review guideline on electrical vaginal microscope
QA/Recall/AE
CFDA announced recall notices to 14 medical devices from 7 foreign manufactures and 4 local ones. Foreign manufacturers include:
- Philips: infant incubator
- Philips: x-ray angiographic system
- Philips: defibrillator
- Medtronic: heater/cooler system
- Medtronic: plasma filter
- Becton Dickinson: vacuum blood collection tube
- Maquet: ventilator
- Zimmer Biomet: hip stem
- Beckman Coulter: automatic urine analyzer
- Smith & Nephew: locking plate
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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------------------------------