Weekly CFDA News Roundup covers government reports, policies, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) a consulting firm specializing in China CFDA regulatory, CRO and market access services.
Government Report
CFDA issued "2017 Medical Device Adverse Event Surveillance Report". China National Adverse Event Surveillance Center received 376,157 reports in the year of 2017, increased by 6.49% from 2016. Reports from healthcare facilities account for 86.83% of the total, and those from manufacturers account for 10.83%. In terms of device category, Class III and Class II devices account for 40.99% and 48.16% of the total respectively.
The 10 most reported medical devices are:
For English version of the Report, please email info@ChinaMedDevice.com.
Policy
CFDA published "Guidance for Electronic Regulated Product Submission (eRPS)". The Guidance applies to imported class II, class III and domestic class III medical devices for registration and clinical trial application.
QA/Recall/AE
CFDA announced 9 recall notices from 6 foreign manufacturers and 3 domestic ones. The foreign manufacturers are:
- Philips: defibrillator
- Boston Scientific: pacemaker wire
- Siemens: gentamicin assay kit
- Abbott: total prostate specific antigen assay
- Smith & Nephew: knee surgical device
- DiaMed: blood grouping reagent IH-card
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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, QA, post market compliance. We are certified as legal agent. 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------------------------------