Recently, Guangzhou LBP Medicine Science & Technology Co., Ltd. successfully passed the 2024 first national supervision and spot check for Class III medical device products. This marks another recognition of LBP's robust quality management and regulatory compliance.
?️ What Is the National Supervision Spot Check?
The national supervision and random inspection of medical devices is a mandatory regulatory activity led by the National Medical Products Administration (NMPA), aimed at strengthening the quality and safety supervision of medical devices and ensuring product performance and compliance with regulatory standards. The inspection process includes product sampling, documentation audits, on-site production reviews, and third-party laboratory testing.
? Products Under Inspection
This round of supervision targeted Class III in vitro diagnostic reagents, including:
HER2 gene detection kit (fluorescence in situ hybridization method) for breast and gastric cancer.
HPV genotyping test kit (PCR + melting curve analysis).
Both products are key components of LBP’s tumor diagnostics pipeline and had previously passed rigorous registration testing and clinical validation before receiving marketing approval.
? Inspection Outcome
Through a multi-phase review including product sampling, documentation checks, and laboratory testing— LBP’s products met all regulatory and technical standards without any non-conformities or risk indicators. This positive result once again reflects the company’s strict adherence to Good Manufacturing Practices (GMP) and its commitment to delivering safe, effective, and high-quality diagnostic solutions.
? Quality First, Steady Global Expansion
As a national-level specialized and innovative enterprise in pathology diagnostics, LBP has always upheld a "quality-first" philosophy. The successful completion of this regulatory spot check further strengthens the company's compliance foundation, providing greater confidence for its partners and healthcare providers both in China and internationally.
Moving forward, LBP will continue to enhance its quality management system, ensuring the safety, reliability, and innovation of its tumor diagnostic products— contributing to the high-quality development of the medical device industry and safeguarding public health.
