Shanghai CFDA office released Medical Device Quarterly Report on April 10. Total 63 medical devices have been voluntarily recalled in Shanghai for the first quarter of 2018, including 58 imported devices (92%) and 5 domestic devices (8%). Foreign manufacturers include Roche, Siemens, GE, Philips, Abbott, Becton Dickinson, Boston Scientific, Smith&Nephew, etc.
The number of voluntary recalls in the first quarter of 2018 was increased by 110% comparing to the last quarter.
All the recalls were classified by category, severity of defects and reason:
Category – 38 active devices, 17 passive devices, and 8 IVDs
Severity of defects – 1 class I recall, 19 class II recall, and 3 Class III recall
Reason – 29 design defects, 21 manufacturing issues, and 9 labeling problem.
Three (3) recommendations were given by Shanghai CFDA:
- Manufacturer should pay attention to the risk of blood glucose strip defects, because the class I recall was for blood glucose strip and the strip has insufficient enzyme content that affects the test results.
- Manufacturer should pay attention to software calibration and update for active devices since active device was accounted for 60% of the total number of recalls and most of them were due to software failures.
- Manufacturer should focus on avoiding external interferences for IVDs since 3 out of 8 IVD recall cases were due to unanticipated external interferences such as drugs and biotin.
This is the first recall report published by provincial CFDA office.
For list of manufactures and reasons for recall, please email info@ChinaMedDevice.com
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.