From June 12 to 14, 2026, an expert evaluation team from the China National Accreditation Service for Conformity Assessment (CNAS) and the National Inspection and Testing Institution Qualification (CMA) conducted a two‑day joint reassessment and scope‑expansion review at the Shanghai Biomaterials Research and Testing Center. Leveraging its robust quality management system and outstanding technical capabilities, the Center received unanimous recognition from the expert panel and successfully passed the evaluation.
The meeting was
presided over by Ms. Qi Baofen, leader of the CNAS/CMA review team and
chief assessor. She provided a detailed explanation of the basis, scope,
methodology, and principles of the on‑site review, as well as the overall work
arrangements. Director Liu Xin then delivered a report to the review team,
outlining the Center’s general profile, the operational status of its
management system, recent upgrades in personnel expertise and facility
capabilities, and its preparatory work for the assessment.
During the review
period, the expert team, in strict accordance with relevant CNAS criteria,
thoroughly examined all aspects of the Center’s operations—including
organizational structure, staff qualifications, laboratory facilities,
instruments and equipment, and management system performance. This was
accomplished through on‑site inspections, document reviews, report sampling,
practical skill tests, and in‑person interviews. The team comprehensively
verified the laboratory’s resource allocation, quality control measures, and
system implementation, with particular emphasis on the compliance of management
system documentation, the standardization of record‑keeping, the effectiveness
of risk response strategies, and the execution of corrective actions.
After two days
of comprehensive, well‑organized, and meticulous on‑site review, the experts
unanimously concluded at the closing meeting that the Shanghai Biomaterials
Research and Testing Center has made significant progress in its overall
development in recent years. Its talent structure has been continuously
optimized, with the addition of several highly educated technical
professionals, steadily enhancing the team’s research and testing capabilities.
The quality system operates effectively, and the technical competence fully
meets all applicable regulatory and technical requirements. Accordingly, the
expert panel approved the Center’s joint CNAS/CMA reassessment and scope‑expansion
review.
On behalf of the
Center, Director Liu Xin expressed sincere gratitude to the hospital
leadership, all functional departments, and the review experts for their
meticulous guidance and strong support. She noted that this review not only
served as a comprehensive verification of the Center’s testing capabilities and
quality management in the field of biological safety evaluation of medical
devices, but also provided an invaluable opportunity to benchmark against
industry standards and identify areas for improvement. Moving forward, the
Center will implement all corrective recommendations point by point, uphold its
quality policy of science, fairness, integrity, and service, and continue to
deepen its work in biological safety evaluation of medical devices. It remains
committed to precisely meeting the testing needs of domestic and international
enterprises, universities, and research institutes, supporting the clinical
translation of innovative domestic medical devices, empowering the high‑quality
development of the hospital, and safeguarding public health and well‑being.
