Weekly CFDA News Roundup covers policies, industry standards, guidance, 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.
Standard
CFDA issued "2018 Medical Device Industry Standard Revision Plan" for feedback. The Plan covers 99 industry standards for medical devices, IVDs, such as mass spectrometer, assisted reproduction device and 3D printed dental device.
For English version of the Plan, please email info@ChinaMedDevice.com.
Guideline
CFDA issued 4 guidelines on May 18:
- Active device: Technical Review Guideline on Surgical Microscope
- Active device: Technical Review Guideline on Tonometer
- Active device: Technical Review Guideline on Pulse Wave Velocity and Ankle-Brachial Index Product
- Passive device: Technical Review Guideline on Cleaning Bench
QA/Recall/AE
CFDA announced a class I recall notice to implantable defibrillator by Abbott. Class I recall is the most urgent type of recall CFDA issues. For the reason of recall and the model number, please email info@ChinaMedDevice.com.
Approval
CFDA published directory of registered medical devices for April 2018. 52 domestic class III, 23 imported class III and 32 imported class II medical devices have been approved. GE, Siemens, Medtronic, Abbott, Johnson & Johnson, BD, Baxter are on the list.
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About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ companies' success.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------