In September, 2021, NMPA published the AE and recall list reported by overseas manufacturers. Since China NMPA enhances the post-market surveillance, such AE and recall events can do help on manufacturers following China regulation.
Manufacturer
Product Name
Recall Class
Recall Reason
Johnson &Johnson Surgical Vision, Inc.
WHITESTAR Signature Phacoemulsification System
III
Small raw material design changes submitted for Japan PMDA in February 2017 were not approved, only involving procedure action error, not affecting the product quality and safety. Not involved in China.
NIHON KOHDEN CORP.
Central monitoring workstation
III
After the product software is upgraded to 05-19, when clicking the trend list on the inpatient review window, the machine will beep and restart automatically. Not involved in China.
Abbott Ireland Diagnostics Division
Total PSA Reagent Kit
III
The Korean IFU was incorrectly replaced by another product. The affected batch was not imported to China.
Smith & Nephew, Inc.
Centralizer
III
After receiving the product complaint, the affected batch of products cannot be used due to material deformation. Not sold in China.
ConvaTec Inc.
DuoDERM CGF Control Gel Formula Border Dressing
III
The inner package of batch 8G03458 may contain wrong products, i.e., the inner package should be square dressing instead of teardrop dressing. The affected batch was not imported to China.
BradyKnows provides the QMS and PMS support for medical device manufacturers to comply China requirement on China market, covering training, onsite audit, remote audit, AE report, recall practice etc. Please reach out to us via info@inspirativemed.com for any questions.
