China NMPA Inspection - Qinghai Dentstar Medical Devices Co., Ltd. - October 20, 2020

The National Medical Products Administration (NMPA) conducted unannounced inspections, announced on October 20, 2020, revealing significant quality management system deficiencies at four medical device enterprises in China. The inspections highlighted non-compliance with the *Good Manufacturing Practice for Medical Devices* and related regulations. Qinghai Dentstar Medical Device Co., Ltd. faced issues including inadequate personnel roles with conflicting responsibilities, production deviations from registered technical requirements, and poor quality control, specifically lacking proper product release procedures and complete inspection documentation. Zhejiang Jinhua Monday Biotechnology Co., Ltd. failed to provide adequate personnel training and maintain critical sterile environment equipment, such as biosafety cabinets, alongside an outdated adverse event monitoring system. Shenzhen Haibo Technology Co., Ltd. demonstrated critical flaws in software development, including developers participating in black-box testing, deficient equipment maintenance documentation, and a lack of proper software version control, traceability analysis, and risk management in design. Beijing Fuaile Technology Development Co., Ltd. was cited for submitting incomplete product registration standards, omitting essential testing items without proper justification. As a result, the NMPA has ordered all four companies to immediately cease production and undertake comprehensive rectification measures. They must also assess product safety risks, initiate recalls if necessary, and are permitted to resume production only after provincial drug regulatory authorities confirm full compliance through re-inspection. Serious legal action will be taken for violations of the *Regulations on the Supervision and Administration of Medical Devices*.