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Beijing Datsing Bio-Tech Co.,LTD passed CE flight Inspection and Version Upgrade Certification

2018-09-10

   

     On September 7, 2018, BSI visited Beijing Datsing Bio-Tech Co., LTD (Beijing Datsing company) for flight inspection. The Audit Team audited the management records, internal audit files, design & development, production and quality control, data analysis, post-market clinical follow-up, adverse event monitoring, risk management and quality control procedures respectively. The audit team listened to the reports of relevant staffs, inspected on site and reviewed relevant records. This audit scope are for the dental desensitizer and bio-degradable hemostatic material. Beijing Datsing company received recognition from the Audit Team for good manufacture practice (GMP) and rigorous quality control and successfully passed the flight inspection

During September 13 and 14, 2018, BSI audited for version upgrade certificate. The Audit Team audited the institution and personnel, premises, equipment, document management, design & development, procurement, production management, quality control, sales, logistics, adverse event monitoring, post-market clinical follow-up, risk management etc., The audit team listened to the  reports of relevant staffs, inspected on site and checked relevant records. This audit scope are for dental desensitizer and bio-degradable hemostatic material. Beijing Datsing company successfully passed the certification under staffs efforts and cooperation.

Small defects in our quality management system were pointed out during the CE flight inspection and version upgrade certification, which will help Beijing Datsing company to improve system continuously and produce safe and effective products. With CE certificates, these products will be exported to international markets. Beijing Datsing company will access to the international market soon.