CFDA issued a Quality Notice and identified 8 types of medical devices with quality issues: RF ablation system, X-ray imaging system, oxygen concentrator, biomedical freezer, surgical blade, etc.
5 foreign manufactures being inspected have no quality issues:
• Sirona Dental Systems GmbH: dental computed tomography X-ray system
• Panasonic Healthcare (Shanghai): biomedical freezer
• Panasonic Healthcare (Dalian): biomedical freezer
• Thermo Fisher: biomedical freezer
• Technolas Perfect Vision GMBH: surgical blade
Among 52 domestic companies, 3 products have quality issues:
• Henan Hualin: vaginal dilator
• Shuangsheng: oxygen concentrator
• Zhufeng: surgical gown
CFDA started to publish Medical Device Quality Notice since February 2016 to improve the quality system and post market compliance of manufacturers in China. A total of 49 notices have been issued in 2 years. The above is the 49th notice. The quality inspections are typically conducted by local CFDA offices where the manufacturers are registered.
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+ western companies’ entry.