NMPA Recall Analysis 3rd Quarter 2020

NMPA Finalized Clinical Trial Approval Catalog
October 2, 2020
NMPA: Nine Guidelines Issued in September
October 11, 2020

NMPA Recall Analysis 3rd Quarter 2020

In the third quarter of 2020, NMPA posted recall notices regarding 26 medical devices and IVDs. Here we provide the analysis of the recalls.

According to Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation (published on Aug 13, 2018, effective since Jan 1, 2019), a Periodic Risk Evaluation Report (PRER)is required to be submitted to NMPA. The report submission date varies based on when the initial NMPA approval has been obtained. Since a China PRER became mandatory on September 30, 2020, It is the obligation of each Market Authorization Holder to fulfill this post-market requirement and submit the report at the appropriate time in order to be compliant with the regulation.  re.

We are experienced in dealing with the issues involved in recalls, domestic & overseas quality inspections. We also have formulated templates for the Periodic Risk Evaluation Report. Email info@ChinaMedDevice.com to get a copy.

complete recall list (manufacturers are listed in alphabetical order)

manufacturerdevicerecall classdate
Arrow InternationalEpidurals Sets and Kits for Epidurals SetsII18-Aug
Beckman Coulterunsaturated iron binding capability test kitIII2-Sep
Becton DickinsonDisposable Sterile SyringeIII18-Aug
BIOMERIEUX S.A.Chocolate AGAR medium (without antibiotics)III4-Sep
BiometKnee Replacement SystemII18-Aug
Biometinverted shoulder joint systemII18-Sep
BiometAcetabular System of Hip ProsthesesII18-Sep
Boston ScientificAngiographic CatheterI17-Aug
Boston ScientificDisposable Poly Lifters, Disposable Electric TrapsIII18-Aug

Cook
ureter stent tubeII2-Sep
Cookpercutaneous nephrostomy catheter setII18-Sep
Datex-OhmedaventilatorII18-Sep
Epocal Inc.Blood Gas SystemIII4-Sep
Hitachifully automatic bio-chemical analyzerIII2-Sep
Inpeco S.A.Automatic sample processing systemIII4-Sep
Irvine BiomedicalInquiry Steerable Diagnostic CathetersII4-Sep
Maquet Critical CareventilatorII18-Sep
PhilipsX-ray Computerized Tomography EquipmentIII18-Aug
Physio-ControlAutomated External DefibrillatorIII18-Aug
Smith & NephewHip Surgical ToolsII18-Aug
Smith & NephewKnee Surgical ToolsIII18-Aug
Stryker MedicalAutomatic Patient BedII18-Aug
SynthesLocking Bone PlatesII18-Sep
Synthesintracranial maxillofacial surgical fixation systemIII2-Sep
XeroxEndoscopy Manual Tools for Endoscopy SurgeryII18-Aug
ZimmerElbow ProstheticsII18-Aug

Indication

Among the 26 recalls, there were five for cardiovascular devices and five for IVDs (clinical chemistry). Seven are related to orthopedic devices which takes up 27% of all recalls from last quarter.

Recall Reason Analysis

The predominant cause of device recalls was the quality issue, which accounts for 46% among all of the recalls, followed by packaging issue and mislabeling.

For more information on cause(s) of any specific device recall, please email info@ChinaMedDevice.com.